Multicenter Ventral Mesh Rectopexy Registry Collaborative

NCT05918367 | Recruiting

• 1 other identifier: 001130
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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. 1.Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications
2. 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?

Conditions

Pelvic Organ Prolapse; Rectocele; Enterocele; Rectal Prolapse; Descending Perineum Syndrome; Surgery

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• recurrence of posterior pelvic organ prolapse - new onset of symptoms

  5 years

• mesh related complications

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (5)

UZ Brussel

Brussels, Belgium

RECRUITING

University Hospital Antwerp

Edegem, 2650, Belgium

RECRUITING

AZ Jan Palfijn

Ghent, Belgium

NOT YET RECRUITING

Jessa ziekenhuis

Hasselt, Belgium

RECRUITING

AZ Delta Roeselare

Roeselare, Belgium

RECRUITING

Related Publications (6)

• 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: 31851453 RESULT

• 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: 25966804 RESULT

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

  PMID: 31651832 RESULT

• 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: 31628853 RESULT

• 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: 17031741 RESULT

• 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.

  PMID: 15499644 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse; Rectocele; Hernia; Rectal Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Sylvie Van den Broeck

CONTACT

003238215744; sylvie.vandenbroeck@uza.be

Niels Komen

CONTACT

00328215007; niels.komen@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2032
• Last Updated: October 25, 2023

Record last verified: 2023-06

Locations

BE (5)