Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy

NCT04130555 | Completed

• 2 other identifiers: RPR_01_CIP2019-A02024-53 (ID-RCB)
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in comparison to the clinical data related to other types of fixation material. The present study will be a prospective multicentric non-randomized and non-controlled trial involving 55 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

Conditions

Rectal Prolapse

Keywords

ventral rectopexy; biological mesh

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events including reoperation and removal of the mesh

  Percentage

  From the surgical procedure through the entire 24-month follow-up period

Secondary Outcomes (9)

• Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated

  Throughout the study until end of the 24-month follow-up period

• Rate of structural defect recurrence requiring reoperation

  Throughout the study until end of the 24-month follow-up period

• Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)

  At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits

• Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)

  At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits

• Rate of symptoms recurrence

  Throughout the study until end of the 24-month follow-up period

Study Arms (1)

CELLIS Rectopexy

Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix

Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)

Interventions

CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM) DEVICE

Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy

CELLIS Rectopexy

Eligibility Criteria

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

Study Population

Constitution and follow-up of a consecutive cohort of patients operated with the CELLIS Rectopexy membrane based on the usual practices, the indication and the inclusion-exclusion criteria.

You may qualify if:

• Patient aged ≥18 years,
• Patient with an indication of rectal prolapse repair by ventral rectopexy (external and internal rectal prolapse),
• Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
• Patient being informed of the porcine origin of the device in advance of the procedure.

You may not qualify if:

• Patient with known hypersensitivity to porcine materials,
• Patient with an existing infection not appropriately treated,
• Patient who are pregnant,
• Patient having refused to participate to the study,
• Patient refusing to come back to the follow-up visits.

Sponsors & Collaborators

• Meccellis Biotech: lead

Study Sites (3)

CHU Estaing

Clermont-Ferrand, 63 003, France

Location

CHU Nantes Hôtel Dieu

Nantes, 44 093, France

Location

Hôpital Haut-Lévèque- CHU de Bordeaux

Pessac, 33 604, France

Location

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillaume MEURETTE, MD

  CHU Nantes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 17, 2019
• Study Start: December 11, 2019
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)