Surgery Clinical Trial
— M2R2Official title:
Multicenter Ventral Mesh Rectopexy Registry Collaborative
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?
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2032 |
Est. primary completion date | September 30, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Brussel | |
Belgium | University Hospital Antwerp | Edegem | |
Belgium | AZ Jan Palfijn | Gent | |
Belgium | Jessa ziekenhuis | Hasselt | |
Belgium | AZ Delta Roeselare | Roeselare |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
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. — View 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. — View 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 O — View Citation
Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional outcome | 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 | |
Primary | 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? | 5 years | ||
Secondary | recurrence of posterior pelvic organ prolapse - new onset of symptoms | 5 years | ||
Secondary | mesh related complications | 5 years |
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