An observational study in Rectal Prolapse, sponsored by Meccellis Biotech. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Meccellis Biotech · Observational
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.
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).
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 55 is below the median of 200 across 21 observational studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Meccellis Biotech is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rectal prolapse repair by ventral rectopexy with the CELLIS Rectopexy matrix
Device: CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy
Rate of adverse events including reoperation and removal of the mesh
Percentage
Time frame: From the surgical procedure through the entire 24-month follow-up period
Rate of structural defect recurrence based on rectal examination with/without adjunctive investigations as clinically indicated
Percentage
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of structural defect recurrence requiring reoperation
Percentage
Time frame: 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)
Described at each visit and compared to baseline
Time frame: 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)
Described at each visit and compared to baseline
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Rate of symptoms recurrence
Percentage
Time frame: Throughout the study until end of the 24-month follow-up period
Severity of disease by the use of the Cleveland Clinic Incontinence Score (CCIS)
Change from screening of total score at each follow-up visit. This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Severity of disease by the use of the Obstructed Defecation Score (ODS)
Change from screening of total score at each follow-up visit. The ODS score is the sum of all points, with a minimum of 0 point and a maximum possible of 31 points with higher scores meaning worse outcome.
Time frame: At baseline and at 30-day, 6-month, 12-month and 24-month follow-up visits
Quality of life by the use of the Short Form (36) Health Survey (SF-36) questionnaire
Change from screening of each domain score and total score at 24-month. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 with lower scores = more disability, and higher scores = less disability
Time frame: At baseline and at 24-month
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.
Summarized and listed
Time frame: During the surgical procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Meccellis Biotech