Multicenter Ventral Mesh Rectopexy Registry Collaborative (M2R2)
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ClinicalTrials.gov Identifier: NCT05918367 |
Recruitment Status :
Recruiting
First Posted : June 26, 2023
Last Update Posted : October 25, 2023
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Tracking Information | |||||||||
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First Submitted Date | June 15, 2023 | ||||||||
First Posted Date | June 26, 2023 | ||||||||
Last Update Posted Date | October 25, 2023 | ||||||||
Actual Study Start Date | September 25, 2023 | ||||||||
Estimated Primary Completion Date | September 30, 2030 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Multicenter Ventral Mesh Rectopexy Registry Collaborative | ||||||||
Official Title | Multicenter Ventral Mesh Rectopexy Registry Collaborative | ||||||||
Brief Summary | 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
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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
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. |
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Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 5 Years | ||||||||
Biospecimen | Not Provided | ||||||||
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) | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
200 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | September 30, 2032 | ||||||||
Estimated Primary Completion Date | September 30, 2030 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Belgium | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT05918367 | ||||||||
Other Study ID Numbers | 001130 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | University Hospital, Antwerp | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | University Hospital, Antwerp | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | University Hospital, Antwerp | ||||||||
Verification Date | June 2023 |