Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma
NCT ID: NCT02841293
Last Updated: 2021-03-04
Study Results
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Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2021-02-07
2024-02-29
Brief Summary
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Detailed Description
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Several strategies are used to decrease the complication rate. Closure by direct approximation of the pelvic muscles leads to a rate of major complication up to 57% depending on the series. Musculocutaneous flaps help to reduce this rate (16- 65%) but they generate their own morbidity, require experience and increase the costs of care. Finally, the use of biologic meshes since the beginning of 2010 seems to have improve the healing process. However, results are still variable and the only randomized study comparing direct closure and mesh closure showed no significant results at one year. Another ongoing randomized trial is comparing gluteus maximus flap to mesh closure and focusing on physical performances.
This increase in post-operative complications and their consequences causes an increase in costs. In addition, they affect the patients' quality of life and lead to a loss of productivity. From an oncological point of view, perineal scarring problems can cause a delay in the adjuvant therapeutic sequence. Few studies have highlighted the efficiency of perineal wound complications, using cost-effectiveness analyses. In order to clarify the best strategy comparing primary and mesh closure in term of cost effectiveness on perineal healing after ELAPE, we designed this randomized controlled trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm with biological mesh
The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)
Biological mesh
The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.
Arm with primary perineal wound closure
The intervention consists of perinal reconstruction by primary perineal wound closure
Primary perineal wound closure
The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure
Interventions
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Biological mesh
The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.
Primary perineal wound closure
The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Etienne BUSCAIL, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Toulouse
Locations
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Amiens University Hospital
Amiens, , France
Angers University Hospital
Angers, , France
Besançon University Hospital
Besançon, , France
Bordeaux University Hospital
Bordeaux, , France
Caen University Hospital
Caen, , France
Clermont-Ferrand University Hospital
Clermont-Ferrand, , France
Grenoble University Hospital
Grenoble, , France
Centre Oscar Lambret
Lille, , France
CHRU Lille
Lille, , France
Lyon University Hospital
Lyon, , France
Paoli Calmettes Institut
Marseille, , France
Institut de Cancérologie de Lorraine
Nancy, , France
Nancy University Hospital
Nancy, , France
Nantes University Hospital
Nantes, , France
Saint-Antoine Hospital
Paris, , France
Rouen University Hospital
Rouen, , France
University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Aurélien VENARA
Role: primary
Emilie DUCHALAIS, MD
Role: primary
References
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Buscail 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.
Other Identifiers
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RC31/16/7940
Identifier Type: -
Identifier Source: org_study_id
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