Multicenter Ventral Mesh Rectopexy Registry Collaborative (M2R2)

• ClinicalTrials.gov Identifier: NCT05918367
• Recruitment Status: Recruiting
• First Posted: June 26, 2023
• Last Update Posted: October 25, 2023
• Sponsor: University Hospital, Antwerp
• Information provided by (Responsible Party): University Hospital, Antwerp

Study Description

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

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?

Condition or disease
Pelvic Organ Prolapse; Rectocele; Enterocele; Rectal Prolapse; Descending Perineum Syndrome; Surgery

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Multicenter Ventral Mesh Rectopexy Registry Collaborative
• Actual Study Start Date: September 25, 2023
• Estimated Primary Completion Date: September 30, 2030
• Estimated Study Completion Date: September 30, 2032

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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?
2. 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 ]

Secondary Outcome Measures :

1. recurrence of posterior pelvic organ prolapse - new onset of symptoms [ Time Frame: 5 years ]
2. mesh related complications [ Time Frame: 5 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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)

Criteria

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)

Contacts and Locations

Contacts

Contact: Sylvie Van den Broeck; 003238215744; sylvie.vandenbroeck@uza.be

Contact: Niels Komen; 00328215007; niels.komen@uza.be

Locations

Belgium

UZ Brussel; Recruiting

Brussel, Belgium

Contact: Jasper Stijns jasper.stijns@uzbrussel.be

University Hospital Antwerp; Recruiting

Edegem, Belgium, 2650

Contact: Sylvie Van den Broeck 00328215744 sylvie.vandenbroeck@uza.be

AZ Jan Palfijn; Not yet recruiting

Gent, Belgium

Contact: Emmelie Reynvoet emmelie.reynvoet@janpalfijngent.be

Jessa ziekenhuis; Recruiting

Hasselt, Belgium

Contact: Bert Houben bert.houben@jessazh.be

AZ Delta Roeselare; Recruiting

Roeselare, Belgium

Contact: Paul Pattyn paul.pattyn@azdelta.be

Sponsors and Collaborators

University Hospital, Antwerp

More Information

Publications of Results:

Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.

Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. Int Urogynecol J. 2015 Nov;26(11):1559-73. doi: 10.1007/s00192-015-2695-8. Epub 2015 May 13.

Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519.

Doumouchtsis SK, Raheem AA, Milhem Haddad J, Betschart C, Contreras Ortiz O, Nygaard CC, Medina CA, La Torre F, Iancu G, Cervigni M, Zanni G. An update of a former FIGO Working Group Report on Management of Posterior Compartment Prolapse. Int J Gynaecol Obstet. 2020 Feb;148(2):135-144. doi: 10.1002/ijgo.13006. Epub 2019 Nov 19.

D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y.

D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779.

• Responsible Party: University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT05918367
• Other Study ID Numbers: 001130
• First Posted: June 26, 2023
• Last Update Posted: October 25, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Antwerp:

Posterior pelvic organ prolapse; descending perineum; ventral mesh rectopexy; functional outcome

Additional relevant MeSH terms:

Rectal Prolapse; Rectocele; Prolapse; Pelvic Organ Prolapse; Hernia; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases