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Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study)
- 作者:Gijsbert D Musters (1)
Willem A Bemelman (1) Robbert JI Bosker (2) Jacobus WA Burger (3) Peter van Duijvendijk (4) Boudewijn van Etten (5) Anna AW van Geloven (6) Eelco JR de Graaf (7) Christiaan Hoff (8) Niels de Korte (9) Jeroen WA Leijtens (10) Harm JT Rutten (11) Baljit Singh (12) Anthony van de Ven (13) Ronald JCLM Vuylsteke (14) Johannes HW de wilt (15) Marcel GW Dijkgraaf (16) Pieter J Tanis (1)
1. Department of Surgery ; Academic Medical Centre ; University of Amsterdam ; Post box 22660 ; Amsterdam ; 1105AZ ; The Netherlands 2. Department of Surgery ; Deventer Hospital ; Post Box 5001 ; Deventer ; 7400CC ; The Netherlands 3. Department of Surgery ; Erasmus Medical Centre / Daniel den Hoed ; Post box 2040 3000 ; Rotterdam ; CA ; The Netherlands 4. Department of Surgery ; Gelre Hospital ; Albert Schweitzerlaan 31 ; Apeldoorn ; DZ ; 7334 ; The Netherlands 5. Department of Surgery ; University Medical Centre Groningen ; University of Groningen ; Hanzeplein 1 ; Groningen ; RB ; 9700 ; The Netherlands 6. Department of Surgery ; Tergooi Hospital ; Post box 10016 ; Hilversum ; DA ; 1201 ; The Netherlands 7. Department of Surgery ; IJsselland hospital ; Post box 690 ; Capelle aan de Ijssel ; AR ; 2900 ; The Netherlands 8. Department of Surgery ; Medical Centre Leeuwarden ; Henri Dunantweg 2 ; LeeuwardenAD ; 8934 ; The Netherlands 9. Department of Surgery ; Spaarne Hospital ; Spaarnepoort 1 ; Spaarne ; TM ; 2134 ; The Netherlands 10. Department of Surgery ; St. Laurentius Hospital ; Monseigneur Driessenstraat 6 ; Roermond ; CV ; 6043 ; The Netherlands 11. Department of Surgery ; Catherina hospital ; Eindhoven ; EJ and Maastricht University Medical Centre ; Michelangelolaan 2 ; P. Debyelaan 25 6229 ; Maastricht ; HX ; 5623 ; The Netherlands 12. Department of Surgery ; Leicester Hospital ; Gwendolen Rd ; Leicester ; UK 13. Department of Surgery ; Flevohospital ; Hospitaalweg 1 ; Almere ; RA ; 1315 ; The Netherlands 14. Department of Surgery ; Kennemer Gasthuis ; Boerhaavelaan 22 ; Haarlem ; RC ; 2035 ; The Netherlands 15. Department of Surgery ; Radboud University Medical Centre ; Geert Grooteplein-Zuid 22 ; Nijmegen ; GA ; 6525 ; The Netherlands 16. Clinical Research Unit ; Academic Medical Centre ; University of Amsterdam ; Post box 22660 ; Amsterdam ; 1105AZ ; The Netherlands
- 关键词:Abdominoperineal resection ; Rectal cancer ; Radiotherapy ; Primary perineal wound closure ; Biological mesh ; perineal wound infection ; Perineal wound healing
- 刊名:BMC Surgery
- 出版年:2014
- 出版时间:December 2014
- 年:2014
- 卷:14
- 期:1
- 全文大小:490 KB
- 参考文献:1. Den Dulk, M, Putter, H, Collette, L, Marijnen, CA, Folkesson, J, Bosset, JF, R枚del, C, Bujko, K, P氓hlman, L, van de Velde, CJ (2009) The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer 45: pp. 1175-1183 CrossRef
2. Stelzner, S, Koehler, C, Stelzer, J, Sims, A, Witzigmann, H (2011) Extended abdominoperineal excision vs. standard abdominoperineal excision in rectal cancer鈥揳 systematic overview. Int J Colorectal Dis 26: pp. 1227-1240 CrossRef 3. Bullard, KM, Trudel, JL, Baxter, NN, Rothenberger, DA (2005) Primary perineal wound closure after preoperative radiotherapy and abdominoperineal resection has a high incidence of wound failure. Dis Colon Rectum 48: pp. 438-443 CrossRef 4. El-Gazzaz, G, Kiran, RP, Lavery, I (2009) Wound complications in rectal cancer patients undergoing primary closure of the perineal wound after abdominoperineal resection. Dis Colon Rectum 52: pp. 1962-1966 CrossRef 5. Nissan, A, Guillem, JG, Paty, PB, Douglas, WW, Minsky, B, Saltz, L, Cohen, AM (2001) Abdominoperineal resection for rectal cancer at a specialty center. Dis Colon Rectum 44: pp. 27-35 CrossRef 6. West, NP, Anderin, C, Smith, KJ, Holm, T, Quirke, P (2010) Multicentre experience with extralevator abdominoperineal excision for low rectal cancer. Br J Surg 97: pp. 588-599 CrossRef 7. Christensen, HK, Nerstrom, P, Tei, T, Laurberg, S (2011) Perineal repair after extralevator abdominoperineal excision for low rectal cancer. Dis Colon Rectum 54: pp. 711-717 CrossRef 8. Butt, HZ, Salem, MK, Vijaynagar, B, Chaudhri, S, Singh, B (2013) Perineal reconstruction after extra-levator abdominoperineal excision (eLAPE): a systematic review. Int J Colorectal Dis 28: pp. 1459-1468 CrossRef 9. Dalton, RS, Smart, NJ, Edwards, TJ, Chandler, I, Daniels, IR (2012) Short-term outcomes of the prone perineal approach for extra-levator abdomino-perineal excision (elAPE). Surgeon 10: pp. 342-346 CrossRef 10. Han, JG, Wang, ZJ, Wei, GH, Gao, ZG, Yang, Y, Zhao, BC (2012) Randomized clinical trial of conventional versus cylindrical abdominoperineal resection for locally advanced lower rectal cancer. Am J Surg 204: pp. 274-282 CrossRef 11. Foster, JD, Pathak, S, Smart, NJ, Branagan, G, Longman, RJ, Thomas, MG, Francis, N (2012) Reconstruction of the perineum following extralevator abdominoperineal excision for carcinoma of the lower rectum: a systematic review. Colorectal Dis 14: pp. 1052-1059 CrossRef 12. Singh, B, Lloyd, G, Nilsson, PJ, Chaudhri, S (2012) Laparoscopic extralevator abdominal perineal excision of the rectum: the best of both worlds. Tech Coloproctol 16: pp. 73-75 CrossRef 13. Bellows, CF, Smith, A, Malsbury, J, Helton, WS (2013) Repair of incisional hernias with biological prosthesis: a systematic review of current evidence. Am J Surg 205: pp. 85-101 CrossRef 14. Peppas, G, Gkegkes, ID, Makris, MC, Falagas, ME (2010) Biological mesh in hernia repair, abdominal wall defects, and reconstruction and treatment of pelvic organ prolapse: a review of the clinical evidence. Am Surg 76: pp. 1290-1299 15. Bebenek, M (2009) Abdominosacral amputation of the rectum for low rectal cancers: ten years of experience. Ann Surg Oncol 16: pp. 2211-2217 CrossRef 16. De Broux, E, Parc, Y, Rondelli, F, Dehni, N, Tiret, E, Parc, R (2005) Sutured perineal omentoplasty after abdominoperineal resection for adenocarcinoma of the lower rectum. Dis Colon Rectum 48: pp. 476-481 CrossRef 17. De Campos-Lobato, LF, Stocchi, L, Dietz, DW, Lavery, IC, Fazio, VW, Kalady, MF (2011) Prone or lithotomy positioning during an abdominoperineal resection for rectal cancer results in comparable oncologic outcomes. Dis Colon Rectum 54: pp. 939-946 CrossRef 18. Bailey, IS, Karran, SE, Toyn, K, Brough, P, Ranaboldo, C, Karran, SJ (1992) Community surveillance of complications after hernia surgery. BMJ 304: pp. 469-471 CrossRef 19. Chadwick, MA, Vieten, D, Pettitt, E, Dixon, AR, Roe, AM (2006) Short course preoperative radiotherapy is the single most important risk factor for perineal wound complications after abdominoperineal excision of the rectum. Colorectal Dis 8: pp. 756-761 CrossRef 20. Han, JG, Wang, ZJ, Gao, ZG, Xu, HM, Yang, ZH, Jin, ML (2010) Pelvic floor reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection. Dis Colon Rectum 53: pp. 219-223 CrossRef 21. Peacock, O, Pandya, H, Sharp, T, Hurst, NG, Speake, WJ, Tierney, GM, Lund, JN (2012) Biological mesh reconstruction of perineal wounds following enhanced abdominoperineal excision of rectum (APER). Int J Colorectal Dis 27: pp. 475-482 CrossRef 22. Vaughan-Shaw, PG, King, AT, Cheung, T, Beck, NE, Knight, JS, Nichols, PH, Nugent, KP, Pilkington, SA, Smallwood, JA, Mirnezami, AH (2011) Early experience with laparoscopic extralevator abdominoperineal excision within an enhanced recovery setting: analysis of short-term outcomes and quality of life. Ann R Coll Surg Engl 93: pp. 451-459 CrossRef 23. Wille-Jorgensen, P, Pilsgaard, B, Moller, P (2009) Reconstruction of the pelvic floor with a biological mesh after abdominoperineal excision for rectal cancer. Int J Colorectal Dis 24: pp. 323-325 CrossRef 24. / EQ-5D-5L Value Sets. [of-eq-5d/eq-5d-5l-value-sets.html" class="a-plus-plus">http://www.euroqol.org/about-eq-5d/valuation-of-eq-5d/eq-5d-5l-value-sets.html] 25. Hakkaart-van Rooijen L: / Handleiding voor kostenonderzoek. [http://www.zorginstituutnederland.nl/binaries/content/documents/zinl-www/documenten/publicaties/overige-publicaties/1007-handleiding-voor-kostenonderzoek/1007-handleiding-voor-kostenonderzoek/Handleiding+voor+kostenonderzoek.pdf] 26. Butler, CE, Gundeslioglu, AO, Rodriguez-Bigas, MA (2008) Outcomes of immediate vertical rectus abdominis myocutaneous flap reconstruction for irradiated abdominoperineal resection defects. J Am Coll Surg 206: pp. 694-703 CrossRef 27. Lefevre, JH, Parc, Y, Kerneis, S, Shields, C, Touboul, E, Chaouat, M, Tiret, E (2009) Abdomino-perineal resection for anal cancer: impact of a vertical rectus abdominis myocutaneus flap on survival, recurrence, morbidity, and wound healing. Ann Surg 250: pp. 707-711 CrossRef 28. Nisar, PJ, Scott, HJ (2009) Myocutaneous flap reconstruction of the pelvis after abdominoperineal excision. Colorectal Dis 11: pp. 806-816 CrossRef 29. Artioukh, DY, Smith, RA, Gokul, K (2007) Risk factors for impaired healing of the perineal wound after abdominoperineal resection of rectum for carcinoma. Colorectal Dis 9: pp. 362-367 CrossRef 30. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2482/14/58/prepub
- 刊物主题:Surgery; Internal Medicine;
- 出版者:BioMed Central
- ISSN:1471-2482
文摘
Background Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. Methods/Design In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. Trail registration number NCT01927497 (Clinicaltrial.gov).
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