- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564677
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
Conditions
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
- Name: Anne Dams, MD
- Phone Number: +32 (0)89 32 60 20
- Email: anne.dams@zol.be
Study Contact Backup
- Name: Stephanie De Munter, PhD
- Phone Number: +32 (0)11 28 69 48
- Email: stephanie.de.munter@archerresearch.eu
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM-ZOL-02
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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