Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy

May 21, 2024 updated by: The University of Texas Medical Branch, Galveston

Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse

The purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (RA SCP).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to tunneling versus dissection technique during RA SCP with the total sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. Subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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
    • Texas
      • Galveston, Texas, United States, 77554
        • University of Texas Medical Branch Galveston

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Females at least 18 years of age at the time of consent.
  2. Able to understand and read English
  3. Able and willing to provide written informed consent
  4. Able to comply with the follow-up study protocol, per clinician judgment
  5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.
  6. RA SCP as desired surgical approach to correct apical prolapse

Exclusion Criteria:

  1. Females who are pregnant, or intend to become pregnant during the study
  2. Texas Department of Criminal Justice prisoners
  3. A known history of sensitivity to propylene mesh
  4. Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)
  5. Active or chronic systemic infection including any pelvic infection, abscess
  6. Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
  7. Prior or current pelvic radiation, or chemotherapy.
  8. Not a candidate for general anesthesia
  9. History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE, Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)
  10. History of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Dissection Technique
The peritoneum is incised superficially and opened longitudinally from the sacral promontory, downward to the posterior cul-de-sac and the posterior vaginal wall to create retroperitoneal space for the SCP mesh.
Procedure: Dissection Technique during RA SCP
As described in the intervention arm above
Experimental: Tunneling Technique
A retroperitoneal tunnel is created by undermining the peritoneum with the robotic scissors and/or needle driver which is placed in the peritoneal opening over the sacral promontory. The tunnel is created just medial to the right uterosacral ligament and toward the posterior vaginal wall by using forward pressure and a sweeping motion to create a space within the retroperitoneum
Procedure: Tunneling Technique during RA SCP
As described in the intervention arm above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time (minutes)
Time Frame: Intraoperative time

Operating time for dissection technique: includes dissection and suturing time. The dissection time starts when the robotic instruments are used to extend the retroperitoneal incision (created during the presacral space dissection) and ends when the extension reaches the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum at the presacral space and ends when the suture is cut after the presacral space, retroperitoneal space and the peritoneum covering the mesh are completely re-approximated.

Operating time for tunneling technique: includes tunneling and suturing time. The tunneling time starts when the robotic instruments are used to undermine the peritoneum and ends when the tunnel is completely created, reaching the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum to close the presacral space and ends when the suture is cut after the peritoneum covering the mesh is completely re-approximated.
Intraoperative time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POP-Q exam
Time Frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
The POP-Q is staged by using the 9 measurements. The stage can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Pelvic Floor Distress Inventory PFDI-20
Time Frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Pelvic Floor Impact Questionnaire PFIQ-7
Time Frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12
Time Frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
The total score of the PISQ-12 questionnaire ranges from 0 to 48. The higher the score is, the better the quality of sexual life.
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Patient Global Impression of Improvement PGI-I
Time Frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Report the patient's response using the response scale from 1-7
Baseline, 6 weeks postoperatively and 12 weeks postoperatively
Decision Regret Scale (DRS)
Time Frame: 6 weeks postoperatively and 12 weeks postoperatively
A five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse.
6 weeks postoperatively and 12 weeks postoperatively
Satisfaction with Decision Scale (SDS)
Time Frame: 6 weeks postoperatively and 12 weeks postoperatively
Scoring consists of taking the mean of the 6 items (range 1 to 5)
6 weeks postoperatively and 12 weeks postoperatively
Clavien-Dindo classification for operative complication
Time Frame: 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively
The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event
2 weeks, 6 weeks postoperatively and 12 weeks postoperatively

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Gokhan Kilic, MD, UTMB

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)

August 10, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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