Multicenter Ventral Mesh Rectopexy Registry Collaborative (M2R2)

October 23, 2023 updated by: University Hospital, Antwerp

The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.

Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.

Following main questions will be analysed - other can follow in consultation with the collaborative

  1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications
  2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study M2R2 is a multicentre registry based on the still ungoing monocentre study in the University Hospital of Antwerp.

Pelvic organ prolapse (POP) is a benign condition in which pelvic organs prolapse beyond their normal anatomical position due to weakening or damage to the pelvic floor muscles and other supporting tissues.[1] The incidence increases with age, multiparity, vaginal delivery and obesity.[2] POP can cause urinary, sexual and bowel complaints with a huge impact on quality of life.[3,4] Patients with posterior compartment prolapse may include symptoms of vaginal swelling, heaviness, perineal pressure and/or obstructive defecation with fragmented stools, need for hard straining, feeling of incomplete emptying, splinting, faecal urgency and even incontinence.[4] Ventral mesh rectopexy is surgical technique used to treat posterior compartment prolapse (rectocele, enterocele, sigmoidocele, rectal prolapse, combination) in patients with symptoms where conservative therapy fails or is ineffective. In this procedure, a mesh is placed between the back wall of the vagina and the rectum, the rectovaginal septum. This is attached at the level of the bone higher up (the promontorium) so that the back wall of the vagina is reinforced, preventing the prolapse to recurre.This technique was first described as technique to treat rectal prolapse by d'Hoore, a colorectal surgeon and widely accepted given the feasible transabdominal technique with good functional results. However, whether this technique gives also effective long-term anatomical and functional outcomes for rectoceles, enteroceles/sigmoidoceles +/- perineal descent, besides rectal prolapse, is not known.[5,6] Sometimes a combined procedure is necessary in which the anterior compartment (bladder) and/or middle compartment (cervix/vagina tip) is also reinforced.

The main objective of this registry is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.

Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.

The patients will be recruited from outpatient clinic of abdominal surgery in the participating centers. The treating physician recruits patients.

Methods and analysis

  1. Data registry Parameters will be registered by means of case record form: History of the patient, urinary, prolapse, defecatory complaints, MRI or CR CCD if performed, anal manometry if performed, results of pelvic floor physiotherapy if performed. Surgical technique, operation time/length of stay and complications.

  2. Questionnaire send to the patients at 5 time points

    Preoperative - 3 months - 1 year - 3 years - 5 years postoperative

    Questionnaires consisting of different topics I. In female: questions about childbirth (only preoperative) II. Medication III. Inventarisation of pelvic floor (dys)- function: PFDI-20 IV. Intestinal function and constipation

    • Wexner Vaizey-score
    • Low anterior resection syndrome score (LARS)
    • Bristol stool chart
    • Rome IV criteria functionam obstipation
    • Rome IV criteria IBS
    • CCS (Wexner constipation score)

    V. Urinary (ICIQ-SF) VI. Seksuality (PISC-IR) VII. Impact of pelvic floor problem on quality of life (PISQ-7) VIII. Subjective satisfaction after surgery

  3. Data management

Collected data will be entered in a case record form by the treating physician of the participating centre or by assigned study staff using the RedCap platform. Patients will be coded to insure patient anonymity.

Study Type

Observational

Enrollment (Estimated)

200

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

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined)

Description

Inclusion Criteria:

  • Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.
  • All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.

Exclusion Criteria:

  1. Inability to complete a written informed conscent
  2. Pregnant women
  3. No email adress available to send the questionnaires to
  4. Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 5 years
Evaluation of the long-term functional outcomes of ventral mesh rectopexy (VMR) for posterior organ prolapse. Is VMR the surgical technique of choice for treatment of rectoceles?
5 years
Has perineal descent has an impact on the functional outcome of ventral mesh rectopexy performed for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidocele or combined pelvic organ prolapse?
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence of posterior pelvic organ prolapse - new onset of symptoms
Time Frame: 5 years
5 years
mesh related complications
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

University Hospital, Antwerp

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)

September 25, 2023

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2032

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001130

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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