Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-05 @ 8:18 PM
Study NCT ID:
NCT05918367
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Ventral Mesh Rectopexy Registry Collaborative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D020047', 'term': 'Rectocele'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D012005', 'term': 'Rectal Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '5 years', 'description': '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?'}, {'measure': '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?', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'recurrence of posterior pelvic organ prolapse - new onset of symptoms', 'timeFrame': '5 years'}, {'measure': 'mesh related complications', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterior pelvic organ prolapse', 'descending perineum', 'ventral mesh rectopexy', 'functional outcome'], 'conditions': ['Pelvic Organ Prolapse', 'Rectocele', 'Enterocele', 'Rectal Prolapse', 'Descending Perineum Syndrome', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '31851453', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25966804', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31651832', 'type': 'RESULT', 'citation': 'Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519.'}, {'pmid': '31628853', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17031741', 'type': 'RESULT', 'citation': "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."}, {'pmid': '15499644', 'type': 'RESULT', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nSecondly complications (mesh erosions, recurrence, reoperations) are evaluated.\n\nFollowing main questions will be analysed - other can follow in consultation with the collaborative\n\n1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications\n2. 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?', 'detailedDescription': "The study M2R2 is a multicentre registry based on the still ungoing monocentre study in the University Hospital of Antwerp.\n\nPelvic 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.\n\nThe 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.\n\nSecondly complications (mesh erosions, recurrence, reoperations) are evaluated.\n\nThe patients will be recruited from outpatient clinic of abdominal surgery in the participating centers. The treating physician recruits patients.\n\nMethods and analysis\n\n1. 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.\n2. Questionnaire send to the patients at 5 time points\n\n Preoperative - 3 months - 1 year - 3 years - 5 years postoperative\n\n 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\n * Wexner Vaizey-score\n * Low anterior resection syndrome score (LARS)\n * Bristol stool chart\n * Rome IV criteria functionam obstipation\n * Rome IV criteria IBS\n * CCS (Wexner constipation score)\n\n 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\n3. Data management\n\nCollected 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.\n* All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.\n\nExclusion Criteria:\n\n1. Inability to complete a written informed conscent\n2. Pregnant women\n3. No email adress available to send the questionnaires to\n4. Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)'}, 'identificationModule': {'nctId': 'NCT05918367', 'acronym': 'M2R2', 'briefTitle': 'Multicenter Ventral Mesh Rectopexy Registry Collaborative', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Multicenter Ventral Mesh Rectopexy Registry Collaborative', 'orgStudyIdInfo': {'id': '001130'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jasper Stijns', 'role': 'CONTACT', 'email': 'jasper.stijns@uzbrussel.be'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sylvie Van den Broeck', 'role': 'CONTACT', 'email': 'sylvie.vandenbroeck@uza.be', 'phone': '00328215744'}], 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Ghent', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Emmelie Reynvoet', 'role': 'CONTACT', 'email': 'emmelie.reynvoet@janpalfijngent.be'}], 'facility': 'AZ Jan Palfijn', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bert Houben', 'role': 'CONTACT', 'email': 'bert.houben@jessazh.be'}], 'facility': 'Jessa ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Roeselare', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Paul Pattyn', 'role': 'CONTACT', 'email': 'paul.pattyn@azdelta.be'}], 'facility': 'AZ Delta Roeselare', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}], 'centralContacts': [{'name': 'Sylvie Van den Broeck', 'role': 'CONTACT', 'email': 'sylvie.vandenbroeck@uza.be', 'phone': '003238215744'}, {'name': 'Niels Komen', 'role': 'CONTACT', 'email': 'niels.komen@uza.be', 'phone': '00328215007'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}