Clinical trial NCT02841293: Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominoperineal Resection
Keywords: anorectal carcinoma
perineal filling
cost-utility analysis
biological meshes
primary perineal wound closure
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental Cost-Utility Ratio (ICUR)
timeFrame: At 12 months
Secondary outcomes:
measure: Perineal wound healing
timeFrame: At 1, 3, 6, 9 and 12 months
measure: Pain intensity
timeFrame: From date of randomization until the date of study participation end of patient, assessed up to 12 months
measure: Health related Quality of life
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months
measure: Perineal complications
timeFrame: Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Angers
country: France
facility: Angers University Hospital
city: Besançon
country: France
facility: Besançon University Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Paoli Calmettes Institut
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Saint-Antoine Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Etienne BUSCAIL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.