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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.
Perineal wound problems after abdominoperineal resection (APR) in the context of cancer are frequent. These types of resection problems occur because of wound complications caused by large perineal defects. Indeed, perineal wound complications, perineal abscess, wound dehiscences, chronic fistulas and sinuses lengthen the hospital stays. Futhermore, the standardization of the surgery since the late 2000s and the extralevator technique lead a larger defect and increase i perineal complications.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm with biological mesh | Experimental | The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm) |
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| Arm with primary perineal wound closure | Active Comparator | The intervention consists of perinal reconstruction by primary perineal wound closure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological mesh | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Cost-Utility Ratio (ICUR) | The primary endpoint in this study is based on the assessment of the incremental cost-utility ratio at 1 year, from the collective perspective between biological mesh perineal reconstructions versus. primary perineal closure in patients operated for anorectal carcinoma with proven rectal adenocarcinoma or anal canal epidermoid carcinoma. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perineal wound healing | The perineal wound healing will be assessed using the Southampton wound assessment scale (6-point scale ranging from 0=normal healing to V=deep or severe wound infection) | At 1, 3, 6, 9 and 12 months |
| Pain intensity |
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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:
Voluntary written informed consent
Patients with social security insurance or equivalent social protection
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Etienne BUSCAIL, MD | Contact | 33-561322373 | buscail.e@chu-toulouse.fr | |
| Cindy CANIVET, CRA | Contact | canivet.c@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Etienne BUSCAIL, MD | University Hospital of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University Hospital | Not yet recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33795299 | Derived | 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. |
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| Primary perineal wound closure | Procedure | The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure |
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assessed on an 11-point Numeric Rating Scale (NRS) at baseline before surgical procedure and at least 3 times a day during hospital stay. Thereafter, patients will rate their pain intensity in a patient subject diary every day and immediately before each use of pain medication
| From date of randomization until the date of study participation end of patient, assessed up to 12 months |
| Health related Quality of life | Health related quality of life will be assessed using the EuroQOL EQ-5D-5L questionnaire | 1 month, 3 months, 6 months, 9 months, 12 months |
| Perineal complications | Perineal complications include:
| Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery |
| Angers University Hospital | Not yet recruiting | Angers | France |
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| Besançon University Hospital | Not yet recruiting | Besançon | France |
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| Bordeaux University Hospital | Not yet recruiting | Bordeaux | France |
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| Caen University Hospital | Not yet recruiting | Caen | France |
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| Clermont-Ferrand University Hospital | Not yet recruiting | Clermont-Ferrand | France |
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| Grenoble University Hospital | Not yet recruiting | Grenoble | France |
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| Centre Oscar Lambret | Recruiting | Lille | France |
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| CHRU Lille | Not yet recruiting | Lille | France |
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| Lyon University Hospital | Not yet recruiting | Lyon | France |
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| Paoli Calmettes Institut | Not yet recruiting | Marseille | France |
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| Institut de Cancérologie de Lorraine | Not yet recruiting | Nancy | France |
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| Nancy University Hospital | Not yet recruiting | Nancy | France |
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| Nantes University Hospital | Not yet recruiting | Nantes | France |
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| Saint-Antoine Hospital | Not yet recruiting | Paris | France |
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| Rouen University Hospital | Not yet recruiting | Rouen | France |
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| University Hospital of Toulouse | Recruiting | Toulouse | 31059 | France |
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