Abdominoperineal ResectionGRECCAR-9NCT02841293
Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma
A study testing Biological mesh and Primary perineal wound closure in people with Abdominoperineal Resection, run by University Hospital, Toulouse at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominoperineal Resection
- What is being tested?
- Biological mesh and Primary perineal wound closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 20 sitesFrance
- Study dates
- 7 Feb 2021to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- Sensitivity to porcine derived products.
- Enrolment in trial with overlapping primary endpoint.
- Pregnant women
- Breastfeeding women
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Amiens University Hospital
Amiens
Angers University Hospital
Angers
Besançon University Hospital
Besançon
Clinique Tivoli Ducos
Bordeaux, 33000
Bordeaux University Hospital
Bordeaux
Caen University Hospital
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Grenoble University Hospital
Grenoble
Centre Oscar Lambret
Lille
CHRU Lille
Lille
Lyon University Hospital
Lyon
Hôpitaux Universitaires de Marseille Nord
Marseille, 13915
Paoli Calmettes Institut
Marseille
Institut de Cancérologie de Lorraine
Nancy
Nancy University Hospital
Nancy
Nantes University Hospital
Nantes
Saint-Antoine Hospital
Paris
Rouen University Hospital
Rouen
Hôpital de Hautepierre (Hôpitaux Universitaires de Strasbourg)
Strasbourg, 67200
University Hospital of Toulouse
Toulouse, 31059
About this study
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
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.
Read the 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.
- Conditions
- Abdominoperineal Resection
- Being tested
- Biological mesh, Primary perineal wound closure
- Keywords
- anorectal carcinoma, perineal filling, cost-utility analysis, biological meshes, primary perineal wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological meshProcedure or surgery
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 closureProcedure or surgery
The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure
| Study group | Role | What they receive |
|---|---|---|
| Arm with biological mesh | Experimental | The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm) Receives: Procedure: Biological mesh |
| Arm with primary perineal wound closure | Active comparator | The intervention consists of perinal reconstruction by primary perineal wound closure Receives: Procedure: Primary perineal wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months
Secondary outcomes (4)
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)
Measured: At 1, 3, 6, 9 and 12 months
Pain intensity
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
Measured: 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
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Perineal complications
Perineal complications include:
- Perineal wound infection defined as a swelling of the wound or surrounding tissues with purulent discharge
- Breakdown of the perineal wound included any wound dehiscence, sinus or ulcer
- Pelvic abscess included a fluid collection in the pelvis
- Perineal evisceration defined by exposure of the pelvic cavity through the perineal wound
- Perineal hernia symptomatic or not
- Perineal sinus defined as an incomplete healing after 6 months
Measured: Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start7 Feb 2021
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominoperineal ResectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne BUSCAIL, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841293
- Sponsor's protocol ID
- RC31/16/7940
- Acronym
- GRECCAR-9
- Status last verified
- Nov 2026
- First submitted
- 12 Jul 2016
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33795299
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02841293
- Acronym / sponsor ID
- GRECCAR-9 / RC31/16/7940
- Conditions
- Abdominoperineal Resection
- Keywords
- anorectal carcinoma, perineal filling, cost-utility analysis, biological meshes, primary perineal wound closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm with biological mesh | Experimental | Procedure: Biological meshThe intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm) |
| Arm with primary perineal wound closure | Active comparator | Procedure: Primary perineal wound closureThe intervention consists of perinal reconstruction by primary perineal wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological meshThe 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. | Procedure or surgery | Arm with biological mesh |
| Primary perineal wound closureThe intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure | Procedure or surgery | Arm with primary perineal wound closure |
Primary outcome
Incremental Cost-Utility Ratio (ICUR)
Time frame: At 12 months
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.
4 secondary outcomes
Perineal wound healing
Time frame: At 1, 3, 6, 9 and 12 months
Pain intensity
Time frame: From date of randomization until the date of study participation end of patient, assessed up to 12 months
Health related Quality of life
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Perineal complications
Time frame: Daily during hospitalization and at 1, 3, 6, 9 and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 33795299Buscail 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne BUSCAIL, MD principal investigator
University Hospital of Toulouse
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological mesh and Primary perineal wound closure in people with Abdominoperineal Resection, run by University Hospital, Toulouse at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-Utility Ratio (ICUR) (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.