Clinical trial NCT04130555: Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
Official title: Observational Prospective Study of a Non-cross-linked Porcine Acellular Dermal Matrix in Ventral Mesh Rectopexy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Prolapse
Keywords: ventral rectopexy
biological mesh
Lead sponsor: Meccellis Biotech
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of CELLIS Rectopexy used in rectal prolapse repair by ventral rectopexy.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 3 investigational centres including 55 patients scheduled for the repair of rectal prolapse.

Each patient will participate in one assessment period including a screening visit, followed by the day of surgical procedure and a hospitalization period. Patients will return for ambulatory visits at Day 30 (+/- 7 days), Month 6 (+/- 2 weeks), Month 12 (+/- 2 weeks) and Month 24 (+/-2 weeks).

The surgical technique used to repair rectal prolapse will be either Laparoscopic Ventral Rectopexy (LVR) or a robotic assisted rectopexy with the use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of adverse events including reoperation and removal of the mesh
timeFrame: From the surgical procedure through the entire 24-month follow-up period
Secondary outcomes:
measure: Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: Rate of structural defect recurrence requiring reoperation
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: Symptoms evolution: presence or absence of symptoms (constipation, fecal incontinence, bloody and/or mucous rectal discharge (soiling), unsatisfactory sexual activity, pain)
timeFrame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
measure: Symptoms severity scored by a visual analog scale (0-10; 0 corresponding to no impact on life and 10 corresponding to extreme, incapacitating impact)
timeFrame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
measure: Rate of symptoms recurrence
timeFrame: Throughout the study until end of the 24-month follow-up period
measure: Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)
timeFrame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
measure: Severity of disease by the use of the Obstructed Defecation Score (ODS)
timeFrame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
measure: Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire
timeFrame: At baseline and at 24-month
measure: Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
timeFrame: During the surgical procedure
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Nantes
country: France
facility: CHU Nantes Hôtel Dieu
city: Pessac
country: France
facility: Hôpital Haut-Lévèque- CHU de Bordeaux
Study officials:
affiliation: CHU Nantes, France
name: Guillaume MEURETTE, MD
role: PRINCIPAL_INVESTIGATOR
References: