- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638235
Pelvic Floor Repair Systems for Prolapse Repair (PROPEL)
A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
- This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
- The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
- The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
- The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
- Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
Study Overview
Status
Conditions
Intervention / Treatment
- Device: AMS Apogee™ with IntePro
- Device: AMS Apogee™ with Intexen LP
- Device: AMS Perigee™ with IntePro
- Device: AMS Perigee™ with IntePro Lite
- Device: AMS Apogee™ with IntePro Lite
- Device: AMS Elevate™ Apical & Posteiror with IntePro Lite
- Device: AMS Elevate™ Apical & Posteiror with IntXen LP
- Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
- Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium
- UZ Leuven Dept of Urology
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Montpellier, France, 34070
- CMC Beau Soleil
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Paris, France, 75020
- Service urologie de Paris l'Hôpital Tenon
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Paris, France
- Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest
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Rouen, France, 76031
- CHU de Rouen - Pavillon Derocque - Rez de Chaussée
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Strasbourg, France, 67082
- Clinique Adassa
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Alzey, Germany, 55232
- Dr. Rainer Lange
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Munich, Germany, 81679
- Beckenbodenzentrum Munich
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Amsterdam, Netherlands, 1105AZ
- University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics
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Barcelona, Spain, 08906
- Hospitalet General de l'Hospitalet
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Leicester, United Kingdom, LE5 4PW
- University Hospital of Leicester NHS Trust
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California
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Downey, California, United States, 90242
- Kaiser Permanente - Dept. of Obstetrics & Gynecology
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Florida
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Wellington, Florida, United States, 33414
- Institute for Women's Health & Body
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Georgia
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Alpharetta, Georgia, United States, 30005
- Atlanta Medical Research Institute
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rosemark WomenCare Specialists
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Partners
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Portland, Maine, United States, 04102
- Fore River Urology
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Massachusetts
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Whitinsville, Massachusetts, United States, 01588
- Female Pelvic Health
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Female Pelvic Medicine and Urogynecology Inst. of Michigan
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Grand Rapids, Michigan, United States, 49546
- Michigan Medical P.C.
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Paw Paw, Michigan, United States, 49079
- Women's Health Care Specialists, PC
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Minnesota
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Plymouth, Minnesota, United States, 55441
- Metro Urology
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North Carolina
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Gastonia, North Carolina, United States, 28054
- Piedmont Urology Associates
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Ohio
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Englewood, Ohio, United States, 45322
- Huey & Weprin Obstetrics & Gynecology
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South Carolina
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Columbia, South Carolina, United States, 29201
- South Carolina OB/GYN
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee - Dept of Obstetrics & Gynecology
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Texas
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El Paso, Texas, United States, 79905
- Texas Tech University Health Science Center - OB/GYN Department
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion Criteria:
- The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
- Subject has had radiation therapy to the pelvic area.
- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- Subject has a known hypersensitivity to the graft material(s).
- Subject has uncontrolled diabetes.
- Subject is on any medication which could result in compromised immune response, such as immune modulators.
- Subject was involved in any other research trial < 30 days of enrollment into this study.
- Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- Subject is unwilling or unable to give valid informed consent.
- Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
- Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Phase I (IntePro, US only)
AMS Apogee™ with IntePro(Began May 2006 - Closed)
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Mesh implant for posterior wall pelvic organ prolapse
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Phase I (InteXen LP, US only)
AMS Apogee™ with InteXen LP (Began May 2006 - Closed)
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Graft implant for posterior wall pelvic organ prolapse
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Phase II (France only)
AMS Perigee™ with IntePro (Began February 2007 - Closed)
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Mesh implant for anterior wall pelvic organ prolapse
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Phase III/IV (Perigee IntePro Lite, US only)
AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
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Mesh implant for anterior wall pelvic organ prolapse
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Phase III/IV (Apogee IntePro Lite, US only)
AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)
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Mesh implant for posterior wall pelvic organ prolapse
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Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical & Posteiror with IntePro Lite (Began April 2008 - Closed)
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Mesh implant for apical and posterior wall pelvic organ prolapse
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Phase V (Elevate Posterior InteXen, US only)
AMS Elevate™ Apical & Posteiror with IntXen LP (Began April 2008 - Closed)
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Graft implant for apical and posterior wall pelvic organ prolapse
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Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)
AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed)
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Mesh implant for anteiror and apical wall pelvic organ prolapse
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Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 2, Began April 2009 - Closed)
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Mesh implant for anteiror and apical wall pelvic organ prolapse
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure
Time Frame: 12-months
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Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
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12-months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
Time Frame: 12-months
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Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
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12-months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
Time Frame: 12-months
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Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF).
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
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12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Time Frame: 6 Months
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Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. |
6 Months
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Procedural Time
Time Frame: Approximately 30 minutes
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Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device.
Procedure duration in minutes
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Approximately 30 minutes
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Estimated Blood Loss
Time Frame: Approximately 30 minutes
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Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml
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Approximately 30 minutes
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Percent of Subjects Experiencing Major Device Related Complications
Time Frame: Through 24 months
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This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure
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Through 24 months
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Rate of Graft Extrusions
Time Frame: Through 24 months
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Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall
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Through 24 months
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Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Time Frame: Through 24 months
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Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence
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Through 24 months
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Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
Time Frame: baseline and 6 weeks
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Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure
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baseline and 6 weeks
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Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Time Frame: 6 Months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
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6 Months
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Surgical Revision Rate
Time Frame: Through 24 months
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The monitoring of AEs occured through the end of the follow up period.
Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
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Through 24 months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
Time Frame: 6 months
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The POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
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6 months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
Time Frame: 24 months
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The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note:
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24 months
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Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Time Frame: 12 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
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12 months
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Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Time Frame: 24 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note:
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24 months
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Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Time Frame: 6 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
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6 months
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Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Time Frame: 12 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
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12 months
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Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Time Frame: 24 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
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24 months
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Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Time Frame: 6 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
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6 months
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Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Time Frame: 12 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
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12 months
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Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
Time Frame: 24 months
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Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
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24 months
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Wong-Baker Faces Pain Scale at 3 Months Post Procedure
Time Frame: baseline and 3 months
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Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure
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baseline and 3 months
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Time Frame: 12 months
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Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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12 months
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Time Frame: baseline and 24 months
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Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 24 months
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
Time Frame: baseline and 6 months
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Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented. .
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baseline and 6 months
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
Time Frame: baseline and 12 months
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Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 12 months
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QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
Time Frame: baseline and 24 months
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Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 24 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M
Time Frame: baseline and 6 months
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Quality of Life as measure by PFDI subscale UDI.
UDI scale ranges from 0-100 with 100 representing the most urinary distress.
Changes in UDI scores between follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 6 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
Time Frame: baseline and 12 months
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Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 12 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
Time Frame: baseline and 24 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 24 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
Time Frame: baseline and 6 months
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Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 6 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
Time Frame: baseline and 6 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
|
baseline and 6 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
Time Frame: baseline and 12 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
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baseline and 12 months
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QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
Time Frame: baseline and 24 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
|
baseline and 24 months
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
Time Frame: baseline and 12 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
|
baseline and 12 months
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
Time Frame: baseline and 24 months
|
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI).
PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op.
QoL scores for follow-up and baseline were presented.
Only data from those subjects who completed both baseline and follow-up were presented.
|
baseline and 24 months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
Time Frame: 6 months
|
Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
6 months
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Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
Time Frame: 24 months
|
Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
24 months
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
Time Frame: 6 months
|
Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF).
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
6 months
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
Time Frame: 24 months
|
Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF).
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure
Time Frame: 6 months
|
Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
6 months
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure
Time Frame: 24 months
|
Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method.
Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures.
Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing.
Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James C. Lukban, DO, Eastern Virginia Medical School
Publications and helpful links
General Publications
- Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. doi: 10.1007/s00192-012-1692-4. Epub 2012 Mar 15.
- Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10.
- Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. doi: 10.1007/s00192-012-1744-9. Epub 2012 May 10.
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Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Organ Prolapse
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University of CalgaryAlberta Health services; Cook Group IncorporatedCompletedAnterior Pelvic Organ ProlapseCanada
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Coloplast A/SCompletedPelvic Organ Prolapse (POP)United States
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University of British ColumbiaCompletedPelvic Organ Prolapse, Patient EducationCanada
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University of MelbourneCompletedVaginal Hysterectomy | Pelvic Organ Prolapse Vaginal SurgeryAustralia
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Unity Health TorontoUnknownVoiding Dysfunction After Pelvic Organ Prolapse SurgeryCanada
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Nykøbing Falster County HospitalZealand University Hospital; University Hospital, Gentofte, Copenhagen; Copenhagen...UnknownBenign Hysterectomy | Postoperative Pelvic Organ Prolapse | Suspension
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Mackay Medical CollegeRecruitingPelvic Organ Prolapse | Stage III and IV High Grade Pelvic Organ ProlapseTaiwan
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Peking Union Medical College HospitalUnknown
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Gaziosmanpasa Research and Education HospitalRecruitingPatients With Pelvic Organ Prolapse | Pectopexy | Lateral Suspension | Pop-q | Pisq-12Turkey
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Charles University, Czech RepublicUnknownPelvic Organ Prolapse RecurrenceCzech Republic
Clinical Trials on AMS Apogee™ with IntePro
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ASTORA Women's HealthCompletedVaginal ProlapseUnited States
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Assistance Publique - Hôpitaux de ParisUnknown
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American Medical SystemsCompletedErectile DysfunctionUnited States
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Boston Scientific CorporationCompletedStress Urinary IncontinenceBelgium, France
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Shanghai Zhongshan HospitalRecruitingCOVID-19 | Hydrogen-oxygen Gas | AMS-H-03China
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Guangzhou Institute of Respiratory DiseaseNot yet recruitingCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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Guangzhou Institute of Respiratory DiseaseUnknownCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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Ruijin HospitalActive, not recruitingCovid19 | Hydrogen-oxygen Gas | AMS-H-03China
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The Cleveland ClinicCompleted
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Indiana UniversityCompletedColorectal NeoplasmsUnited States