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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Device: Ifabond (Péters surgical)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duomed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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