A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)

October 9, 2023 updated by: Duomed

A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

      • Genk, Belgium
        • Recruiting
        • Ziekenhuis Oost-Limburg (ZOL)
        • Contact:
          • Anne Dams, MD
          • Phone Number: +32 (0)89 32 60 20

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.

Description

Inclusion Criteria:

  • Female patients.
  • Patient ≥ 18 years of age at study entry.
  • Patient and investigator signed and dated the informed consent form prior to the index-procedure.
  • Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.

Exclusion Criteria:

  • Patient is unable / unwilling to provide informed consent.
  • Patient with recurrent rectal prolapse, rectocele and/or enterocele.
  • Patient is unable to comply with the study protocol or proposed follow-up visits.
  • Patient has a contra-indication for laparoscopic ventral mesh rectopexy.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: During procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
During procedure
Procedural efficacy - Conversion rate to laparotomy during the index procedure
Time Frame: During procedure
Number of conversions to laparotomy during the index procedure
During procedure
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: At discharge (assessed up to 1 week)
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
At discharge (assessed up to 1 week)
Procedural efficacy - Number of re-interventions
Time Frame: At discharge (assessed up to 1 week)
Number of re-interventions
At discharge (assessed up to 1 week)
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of re-interventions
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of re-interventions
Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of post-operative recurrences
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
Number of post-operative recurrences
Follow-up 1: 6 - 10 weeks after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: Follow-up 2: 12 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of re-interventions
Time Frame: Follow-up 2: 12 months after the procedure
Number of re-interventions
Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Time Frame: Follow-up 2: 12 months after the procedure
Number of post-operative recurrences
Follow-up 2: 12 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: Follow-up 3: 24 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of re-interventions
Time Frame: Follow-up 3: 24 months after procedure
Number of re-interventions
Follow-up 3: 24 months after procedure
Procedural efficacy - Number of post-operative recurrences
Time Frame: Follow-up 3: 24 months after the procedure
Number of post-operative recurrences
Follow-up 3: 24 months after the procedure
Procedural efficacy - Number of participants with (serious) adverse events
Time Frame: Follow-up 4: 36 months after the procedure
Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo
Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of re-interventions
Time Frame: Follow-up 4: 36 months after the procedure
Number of re-interventions
Follow-up 4: 36 months after the procedure
Procedural efficacy - Number of post-operative recurrences
Time Frame: Follow-up 4: 36 months after the procedure
Number of post-operative recurrences
Follow-up 4: 36 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time Frame: At baseline
Assessment of pre-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
At baseline
Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time Frame: At baseline
Assessment of pre-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
At baseline
Functional score - Obstructive Defecation Syndrome (ODS) score
Time Frame: At baseline
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
At baseline
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time Frame: At baseline
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
At baseline
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time Frame: At baseline
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
At baseline
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 1: 6 - 10 weeks after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 2: 12 months after the procedure
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 2: 12 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 3: 24 months after the procedure
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 3: 24 months after the procedure
Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 4: 36 months after the procedure
Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 4: 36 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 1: 6 - 10 weeks after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 2: 12 months after the procedure
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 2: 12 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 3: 24 months after the procedure
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 3: 24 months after the procedure
Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
Time Frame: Follow-up 4: 36 months after the procedure
Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Follow-up 4: 36 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time Frame: Follow-up 2: 12 months after the procedure
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Follow-up 2: 12 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time Frame: Follow-up 3: 24 months after the procedure
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Follow-up 3: 24 months after the procedure
Functional score - Obstructive Defecation Syndrome (ODS) score
Time Frame: Follow-up 4: 36 months after the procedure
The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms.
Follow-up 4: 36 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Follow-up 1: 6 - 10 weeks after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time Frame: Follow-up 2: 12 months after the procedure
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Follow-up 2: 12 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time Frame: Follow-up 3: 24 months after the procedure
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Follow-up 3: 24 months after the procedure
Functional score - Cleveland Clinical Incontinence Score (CCIS)
Time Frame: Follow-up 4: 36 months after the procedure
The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms.
Follow-up 4: 36 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time Frame: Follow-up 1: 6 - 10 weeks after the procedure
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Follow-up 1: 6 - 10 weeks after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time Frame: Follow-up 2: 12 months after the procedure
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinart symptoms. Higher scores are indicative of more severe symptoms.
Follow-up 2: 12 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time Frame: Follow-up 3: 24 months after the procedure
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Follow-up 3: 24 months after the procedure
Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
Time Frame: Follow-up 4: 36 months after the procedure
The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms.
Follow-up 4: 36 months after the procedure

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Anne Dams, MD, Ziekenhuis Oost-Limburg (ZOL)

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)

February 8, 2021

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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