BIOPEX 2-study: Gluteal turnover flap for closure of the perineal wound after abdominoperineal resection for rectal cancer
Trial Overview
| Acronym | BIOPEX 2-study |
|---|---|
| Number | NL65461.018.18 |
| Protocol Link | https://clinicaltrials.gov/ct2/show/NCT01927497 |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT01927497 |
| Status | In Preparation/Starting |
| Category | Colorectal Cancer - Rectal Specific |
| Treatment Course | Surgery |
Trial Description
| BIOPEX 2-study is a multicentre study in which patients undergoing an abdominoperineal resection for (recurrent) rectal cancer are randomised between standard care using primary closure of the perineum and the experimental arm with assisted closure using a gluteal turnover flap. |
Chief Investigator
|
P.J. Tanis Dr. |
| Profile Link |
Lead Centre
|
Amsterdam UMC, location AMC Meibergdreef 9 Amsterdam 1105AZ The Netherlands |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. IJsselland Hospital Prins Constantijnweg 2 Capelle aan den IJssel 2906ZC The Netherlands Contact: Dr. E.J.R. de Graaf Website |
| 2. Catharina Hospital Michelangelolaan 2 Eindhoven 5623EJ The Netherlands Contact: Dr. J.W.A. Burger Website |
| 3. St. Laurentius Hospital Monseigneur Driessenstraat 6 Roermond 6043CV The Netherlands Contact: Dr. J.W.A. Leijtens Website |
| 4. Radboud University Medical Centre Geert Grooteplein Zuid 10 Nijmegen 6525GA The Netherlands Contact: Prof. dr. H.W. de Wilt Website |
| 5. Erasmus Medical Centre Doctor Molewaterplein 40 Rotterdam 3015GD The Netherlands Contact: Dr. J. Rothbarth Website |
| 6. Deventer Hospital Nico Bolesteinlaan 75 Deventer 7416SE The Netherlands Contact: Dr. R.J.I. Bosker Website |
| 7. Flevo Hospital Hospitaalweg 1 Almere 1315RA The Netherlands Contact: A.W.H. van de Ven Website |
| 8. Bravis Hospital Boerhaavelaan 25 Roosendaal 4708AE The Netherlands Contact: H. Fabry Website |
| 9. Antoni van Leeuwenhoek Hospital Plesmanlaan 121 Amsterdam 1066CX The Netherlands Contact: Prof. dr. G. Beets Website |
| 10. University Hospital of Leicester Gwendolen Rd Leicester LE5 4PW United Kingdom Contact: Dr. B. Singh Website |
| 11. Amsterdam UMC, location VUmc De Boelelaan 1117 Amsterdam 1081HV The Netherlands Contact: Dr. J. Tuynman Website |
| 12. Tergooi Hospital Van Riebeeckweg 212 Hilversum 1213XZ The Netherlands Contact: Dr. A.A.W. van Geloven Website |
Funding Sponsors
| 1. KWF Kankerbestrijding |
Additional Information
Full Research Summary| Objective: | Morbidity after abdominoperineal resection (APR) is substantial and mainly consisting of perineal wound problems in about 35% of the patients. lf primary healing of the perineal wound after APR does not occur, secondary healing can take up to one year, and there is even a small proportion of patients in whom a chronic perineal wound or fistula. persists after one year. During this long period, intensive wound care is necessary. This results in a heavy burden on both patient and health care resources. The high morbidity rate of the perineal wound has resulted in a continuing discussion on how to close the perineal defect after APR. Our research group recently published the BIOPEX-study (NL42094.018.12), in which 104 patients were randomised between primary perineal wound closure and biological mesh closure of the pelvic floor after APR with preoperative radiotherapy tor rectal cancer. Similar uncomplicated perineal wound healing rate at 30 days (Southampton wound score 2) was found: 63% versus 66%, respectively. The hypothesis behind this negative trial result is related to the perineal dead space between the skin and the biological mesh. Fluid will accumulate in this dead space with the risk of secondary contamination and abscess formation, leading to wound dehiscence and purulent discharge. Autologous tissue flaps have been suggested to improve perineal wound healing based on several cohort studies. At least in the Netherlands, these flaps are used only for selected patients with the large defects and highest risk of wound problerns, because of the more extensive surgery with added surgical trauma and operative time, and associated donor site morbidity. For these reasons, primary perineal closure (control arm of BIOPEX) is still the standard of care in the Netherlands. A gluteal turnover flap (GT flap) is a small transposition flap trom the unilateral adjacent perineal skin and subcutaneous fat, which is flipped into the perineal dead space, and stitched with the deepithelialised dermis to the contralateral pelvic floor remnant. Subsequently, the perineal subcutaneous fat and skin are closed over the flap in the midline, thereby not adding a donor site scar. A small pilot study trom our group showed that this is a promising solution for routine perineal closure after APR, following the principle of filling perineal dead space. |
| Aim: | The aim of this study is to determine the additional value of a minimally invasive GT flap for perineal wound healing after APR for (recurrent) rectal cancer in comparison to primary closure. |
| Methods: | In this multicentre single blinded study, eligible patients will be randomised between pelvic floor reconstruction using a GT flap (intervention arm) and primary closure of the perineal defect (standard arm). The perineal wound healing will be evaluated at 14 days, 1, 3, and 6 months postoperatively using the Southamptom wound scoring system by an independent observer. In addition, CT-scan of the pelvis as usally performed during oncological follow-up, will be reviewed with respect to presacral or perineal sinuses and perineal herniation. Quality of Life questionanaires will be administered to the patient at each follow-up interval. In addition, the nature and severity of any wound event, all medical or surgical interventions and re-operations will be collected. The study population will consist of patients older then 18 years with a clinical diagnosis of primary rectal cancer or recurrent rectal cancer who are scheduled for APR, with or without neo-adjuvant (chemo)radiotherapy. Main exclusion criteria are intersphincteric APR, extended resections (sacral resection except for coccyx resection, (posterior) exenteration), severe systemic diseases affecting wound healing except diabetes (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV), collagen disorders (i.e. Marfan), and enrolment in trials with overlapping primary endpoint. |
| Reason for International Trial: | To be able to apply the technique more broadly. |