Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler in Chronic Constipation and Intussusception and Rectocele - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Stapled Transanal Resection (STARR) with Transtar (PROXIMATE®) 33 mm Circular Stapler

Detailed Description

Rectocele and rectal intussusception are frequent findings in women but are often asymptomatic apart from anatomical defects, which can be seen on vaginal examination. They can be associated, however, with refractory constipation that may be best described by the terms "Outlet Obstruction" or "Obstructive Defecation Syndrome (ODS)". ODS is characterized by a symptom complex, including the feeling of incomplete evacuation associated with the need to strain excessively and for external assistance (digital, mechanical or positional maneuvers, enemas or suppositories) to aid defecation. Abdominal or rectal pain is also a common complaint. Obstetric trauma is also recognized as a contributing factor. However, none of these symptoms/factors can be singled out to be pathognomonic for this problem. ODS has a prevalence of approximately 12% in the general population.

For individuals with ODS and related intussusception/rectocele, a variety of surgical techniques including abdominal, vaginal, transanal and perineal approaches have been devised. The impact of clinical studies to evaluate these techniques has been limited by variability of results and lack of comparators. Recently, a new surgical approach was developed by an Italian surgeon, A. Longo, and has been evaluated in several European centers. These early studies and observations indicate that this new procedure may in fact provide significantly better symptom resolution in ODS patients than other available treatments, and warrants further study. The procedure is referred to as "Stapled Transanal Rectal Resection (STARR)" and this study will assess its effectiveness in a United States population.

Study Type

Interventional

Enrollment (Actual)

75

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Orlando, Florida, United States, 32806
    - Colon and Rectal Clinic of Orlando
- Massachusetts
  - Burlington, Massachusetts, United States, 01805
    - Lahey Clinic
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - Colon & Rectal Surgery Associates Ltd.
- Ohio
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44106
    - University Hospitals of Cleveland
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio, Department of Surgery
- Oregon
  - Portland, Oregon, United States, 97205
    - Portland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Able to comprehend, understand, and speak the English language
Able to comprehend, follow, and sign an informed consent document (ICD)
Able to tolerate general or spinal anesthetic
Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
Have experienced ODS symptoms for at least 12 months prior to enrollment
Have a minimum ODS score of 10
Have rectocele and/or rectal intussusception confirmed by defecography
Screened for colorectal neoplasia within 7 years of the screening visit (e.g., colonoscopy or barium enema)
Have an American Society of Anesthesiologists (ASA) score of no more than 3
Willing to comply with evaluation and management schedule through 5-year follow-up

Exclusion Criteria:

Fecal incontinence to solid stool
Full-thickness prolapse
Perineal infection
Recto-vaginal fistula
Enterocele (at rest)
Any complex pelvic floor prolapse requiring a combined surgical approach
Prior sigmoid or anterior resection or prior rectal anastomosis
Presence of foreign material adjacent to the rectum (e.g., vaginal mesh)
Grade IV hemorrhoids
Pregnancy
Chronic narcotic use
Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
Physical or psychological condition which would impair study participation
Unable or unwilling to attend follow-up visits and examinations
Surgical procedure required concurrently with STARR
Prior pelvic radiotherapy
Failure to identify any anatomical or physiological abnormality in the evaluation
Significant rectal fibrosis
Anal stenosis precluding insertion of the stapling device
Participation in any other investigational device or drug study 30 days prior to enrollment
Presence or history of hepatitis B, hepatitis C, and/or HIV positive test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure Time Frame: one year from Baseline	The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.	one year from Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure Time Frame: Baseline, 1 month post procedure	Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.	Baseline, 1 month post procedure
Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM). Time Frame: Baseline, 6 months	Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.	Baseline, 6 months
Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score) Time Frame: Baseline, 6 months post procedure	The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.	Baseline, 6 months post procedure
PAC QOL Patient Assessment of Constipation (Overall) Time Frame: Baseline, 12 months	PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol	Baseline, 12 months
SF-12 QOL Change From Baseline (Physical Component)at 12 Months Time Frame: Baseline, 12 Months	The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.	Baseline, 12 Months
SF-12 QOL Change (Mental Component) at 12 Months From Baseline Time Frame: Baseline, 12 months	SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.	Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Investigators

Study Director: Robin F Scamuffa, MS, Ethicon Endo-Surgery
Study Director: William Bernie, MD, Ethicon Endo-Surgery
Principal Investigator: Anthony J Senagore, MD, Medical University of Ohio
Principal Investigator: Anders F Mellgren, MD, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria