Clinical trial · Interventional
Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma
Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominoperineal Resection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological mesh | Procedure | — | UNRESOLVED |
| Primary perineal wound closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm with biological mesh
- description
- The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)
- interventionNames
- Procedure: Biological mesh
- type
- ACTIVE_COMPARATOR
- label
- Arm with primary perineal wound closure
- description
- The intervention consists of perinal reconstruction by primary perineal wound closure
- interventionNames
- Procedure: Primary perineal wound closure
Primary outcomes (1)
- measure
- Incremental Cost-Utility Ratio (ICUR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Eastern Cooperative Oncology Group performance status score of 2 or less * Histologically proven rectal adenocarcinoma or anal canal epidermoïd carcinoma * Abdominoperineal resection indication after multidisciplinary team discussion: * for rectal adenocarcinoma: circumferential MRI margin equal or less than 1 mm from closest tumoral structure and a striated muscular layer (levator ani or external anal sphincter) * for epidermoid carcinoma: residual or recurrent tumour after chemoradiotherapy. * Voluntary written informed consent * Patients with social security insurance or equivalent social protection Exclusion Criteria: * T4 tumour needing a surgical extensive resection with reconstruction by a musculocutaneous flap * Metastasis disease deemed unresectable with curative intent * Previous pelvic radiotherapy for another disease than the rectal or anal cancer * Immunosuppressive drugs treatment * Uncontrolled diabetes (glycosylated hemoglobin (HbA1c) \> 8 % despite adequate therapy) * Patient under juridical protection. * Sensitivity to porcine derived products. * Enrolment in trial with overlapping primary endpoint. * Pregnant women * Breastfeeding women
References
Publications (1)
- DERIVEDBuscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333. PMID 33795299