Stoma closure and reinforcement (SCAR): A study protocol for a pilot trial

Jenaya L Goldwag, Lauren R Wilson, Srinivas J Ivatury, Eric M Pauli, Michael J Tsapakos, Matthew Z Wilson, Jenaya L Goldwag, Lauren R Wilson, Srinivas J Ivatury, Eric M Pauli, Michael J Tsapakos, Matthew Z Wilson

Abstract

A quality metric for centers performing rectal cancer surgery is a high percentage of sphincter sparing procedures. These procedures often involve temporary bowel diversion to minimize the complications of an anastomotic leak. The most common strategy is a diverting loop ileostomy which is then closed after completion of adjuvant therapy or the patient recovers from surgery. Loop ileostomy is not without complications and the closure is complicated by a one in three chance of incisional hernia development. Strategies to prevent this problem have been designed using a variety of techniques with and without mesh placement. This proposed pilot study will test the safety and efficacy of a novel stoma closure technique involving permanent mesh in the retro rectus position during ileostomy closure. The study will prospectively follow 20 patients undergoing ileostomy closure using this technique and evaluate for safety of the procedure, quality of life, and feasibility for a larger randomized controlled trial. Patients will be followed post procedurally and evaluated for 30-day complications, as well as followed up with routine cancer surveillance computed tomography every 6 months in which the presence of stoma site incisional hernias will be evaluated. The results of this pilot study will inform the design of a multiple center, blinded randomized controlled trial to evaluate the utility of permanent mesh placement to decrease the incidence of prior stoma site incisional hernias.

Keywords: Colorectal cancer; Ileostomy; Incisional hernia.

© 2020 The Authors.

Figures

Fig. 1
Fig. 1
Retro-rectus placement of mesh in abdominal wall.

References

    1. Fujii S., Tsukamoto M., Fukushima Y. Systematic review of laparoscopic vs open surgery for colorectal cancer in elderly patients. World J. Gastrointest. Oncol. 2016;8(7):573–582.
    1. Butler E.N., Chawla N., Lund J. Patterns of colorectal cancer care in the United States and Canada: a systematic review. J. Natl. Canc. Inst. Monogr. 2013;(46):13–35. 2013.
    1. Ricciardi R., Virnig B.A., Madoff R.D. The status of radical proctectomy and sphincter-sparing surgery in the United States: diseases of the colon. & Rectum. 2007;50(8):1119–1127.
    1. Ridolfi T.J., Berger N., Ludwig K.A. Low anterior resection syndrome: current management and future directions. Clin. Colon Rectal Surg. 2016;29(3):239–245.
    1. Nguyen M.T., Phatak U.R., Li L.T. Review of stoma site and midline incisional hernias after stoma reversal. J. Surg. Res. 2014;190(2):504–509.
    1. De Keersmaecker G., Beckers R., Heindryckx E. Retrospective observational study on the incidence of incisional hernias after reversal of a temporary diverting ileostomy following rectal carcinoma resection with follow-up CT scans. Hernia. 2016;20(2):271–277.
    1. Oriel B.S., Chen Q., Itani K.M.F. Incidence, recurrence and risk factors of hernias following stoma reversal. Am. J. Surg. 2017;214(2):232–238.
    1. Schreinemacher M.H., Vijgen G.H., Dagnelie P.C., Bloemen J.G., Huizinga B.F., Bouvy N.D. Incisional hernias in temporary stoma wounds: a cohort study. Arch. Surg. 2011;146(1):94–99.
    1. Sharp S.P., Francis J.K., Valerian B.T., Canete J.J., Chismark A.D., Lee E.C. Incidence of ostomy site incisional hernias after stoma closure. Am. Surg. 2015;81(12):1244–1248.
    1. de Goede B., Eker H.H., Klitsie P.J. Incisional hernia after liver transplantation: risk factors and health-related quality of life. Clin. Transplant. 2014;28(7):829–836.
    1. Urbach D.R. Measuring quality of life after surgery. Surg. Innovat. 2005;12(2):161–165.
    1. Ah-Kee E.Y., Kallachil T., O'Dwyer P.J. Patient awareness and symptoms from an incisional hernia. Int. Surg. 2014;99(3):241–246.
    1. Shubinets V., Fox J.P., Lanni M.A. Incisional hernia in the United States: trends in hospital encounters and corresponding healthcare charges. Am. Surg. 2018;84(1):118–125.
    1. van Ramshorst G.H., Eker H.H., Hop W.C.J. Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am. J. Surg. 2012;204(2):144–150.
    1. Ravn S., Thaysen H.V., Harsløf S. Incisional hernia and its impact on health-related quality of life after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a national prospective cohort study. World J. Surg. Oncol. 2018;16(1)
    1. Itatsu K., Yokoyama Y., Sugawara G. Incidence of and risk factors for incisional hernia after abdominal surgery. Br. J. Surg. 2014;101(11):1439–1447.
    1. Henriksen N.A., Helgstrand F., Vogt K.C., Jorgensen L.N., Bisgaard T. Risk factors for incisional hernia repair after aortic reconstructive surgery in a nationwide study. J. Vasc. Surg. 2013;57(6):1524–1530. 1530.e1521-1523.
    1. Nakayama M., Yoshimatsu K., Yokomizo H. Incidence and risk factors for incisional hernia after open surgery for colorectal cancer. Hepato-Gastroenterology. 2014;61(133):1220–1223.
    1. Connelly T.M., Tappouni R., Mathew P., Salgado J., Messaris E. Risk factors for the development of an incisional hernia after sigmoid resection for diverticulitis: an analysis of 33 patients, operative and disease-associated factors. Am. Surg. 2015;81(5):492–497.
    1. Amelung F.J., de Guerre L.E.V.M., Consten E.C.J. Incidence of and risk factors for stoma‐site incisional herniation after reversal. BJS Open. 2018;2(3):128–134.
    1. Kaneko T., Funahashi K., Ushigome M. Incidence of and risk factors for incisional hernia after closure of temporary ileostomy for colorectal malignancy. Hernia. 2019;Aug; 23(4):743–748. doi: 10.1007/s10029-018-1855-4.
    1. Weissler J.M., Lanni M.A., Hsu J.Y. Development of a clinically actionable incisional hernia risk model after colectomy using the healthcare cost and utilization project. J. Am. Coll. Surg. 2017;225(2):274–284. e271.
    1. Luijendijk R.W., Hop W.C., van den Tol M.P. A comparison of suture repair with mesh repair for incisional hernia. N. Engl. J. Med. 2000;343(6):392–398.
    1. Christoffersen M.W., Helgstrand F., Rosenberg J., Kehlet H., Bisgaard T. Lower reoperation rate for recurrence after mesh versus sutured elective repair in small umbilical and epigastric hernias. A nationwide register study. World J. Surg. 2013;37(11):2548–2552.
    1. Bhangu A., Futaba K., Patel A., Pinkney T., Morton D. Reinforcement of closure of stoma site using a biological mesh. Tech. Coloproctol. 2014;18(3):305–308.
    1. Liu D.S., Banham E., Yellapu S. Prophylactic mesh reinforcement reduces stomal site incisional hernia after ileostomy closure. World J. Surg. 2013;37(9):2039–2045.
    1. Maggiori L., Moszkowicz D., Zappa M., Mongin C., Panis Y. Bioprosthetic mesh reinforcement during temporary stoma closure decreases the rate of incisional hernia: a blinded, case-matched study in 94 patients with rectal cancer. Surgery. 2015;158(6):1651–1657.
    1. Reinforcement of Closure of Stoma Site C, the West Midlands Research C Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement. Colorectal Dis. 2016;18(9):889–896.
    1. van Barneveld K.W., Vogels R.R., Beets G.L. Prophylactic intraperitoneal mesh placement to prevent incisional hernia after stoma reversal: a feasibility study. Surg. Endosc. 2014;28(5):1522–1527.
    1. Simon R. Optimal two-stage designs for phase II clinical trials. Contr. Clin. Trials. 1989;10(1):1–10.
    1. Jensen R.E., Potosky A.L., Moinpour C.M., Lobo T., Cella D., Hahn E.A.…Reeve B.B. United States population-based estimates of patient-reported outcomes measurement information system symptom and functional status reference values for individuals with cancer. J. Clin. Oncol. : Off. J. Am. Soc. Clin. Oncol. 2017;35(17):1913–1920. doi: 10.1200/JCO.2016.71.4410.
    1. Liapi A., Mavrantonis C., Lazaridis P., Kourkouni E., Zevlas A., Zografos G., Theodoropoulos G. Validation and comparative assessment of low anterior resection syndrome questionnaires in Greek rectal cancer patients. Ann. Gastroenterol. 2019;32(2):185–192. doi: 10.20524/aog.2019.0350.
    1. Sharma A., Deeb A.P., Rickles A.S., Iannuzzi J.C., Monson J.R., Fleming F.J. Closure of defunctioning loop ileostomy is associated with considerable morbidity. Colorectal Dis. 2013;15(4):458–462.
    1. Mengual-Ballester M., Garcia-Marin J.A., Pellicer-Franco E. Protective ileostomy: complications and mortality associated with its closure. Rev. Esp. Enferm. Dig. : organo oficial de la Sociedad Espanola de Patologia Digestiva. 2012;104(7):350–354.
    1. Mirbagheri N., Dark J., Skinner S. Factors predicting stomal wound closure infection rates. Tech. Coloproctol. 2013;17(2):215–220.
    1. Lee J.T., Marquez T.T., Clerc D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis. Colon Rectum. 2014;57(11):1282–1289.
    1. Rosen M.J., Bauer J.J., Harmaty M. Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA study. Ann. Surg. 2017;265(1):205–211.
    1. Carbonell A.M., Criss C.N., Cobb W.S., Novitsky Y.W., Rosen M.J. Outcomes of synthetic mesh in contaminated ventral hernia repairs. J. Am. Coll. Surg. 2013;217(6):991–998.
    1. Jimenez-Gomez L.M., Espin-Basany E., Trenti L. Factors associated with low anterior resection syndrome after surgical treatment of rectal cancer. Colorectal Dis. 2017
    1. Park A.E., Roth J.S., Kavic S.M. Abdominal wall hernia. Curr. Probl. Surg. 2006;43(5):326–375.
    1. Baillie D.R., Stawicki S.P., Eustance N., Warsaw D., Desai D. Use of human and porcine dermal-derived bioprostheses in complex abdominal wall reconstructions: a literature review and case report. Ostomy/Wound Manag. 2007;53(5):30–37.
    1. Breuing K., Butler C.E., Ferzoco S. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010;148(3):544–558.
    1. Burns N.K., Jaffari M.V., Rios C.N., Mathur A.B., Butler C.E. Non-cross-linked porcine acellular dermal matrices for abdominal wall reconstruction. Plast. Reconstr. Surg. 2010;125(1):167–176.
    1. Primus F.E., Harris H.W. A critical review of biologic mesh use in ventral hernia repairs under contaminated conditions. Hernia. 2013;17(1):21–30.
    1. Majumder A., Winder J.S., Wen Y., Pauli E.M., Belyansky I., Novitsky Y.W. Comparative analysis of biologic versus synthetic mesh outcomes in contaminated hernia repairs. Surgery. 2016;160(4):828–838.
    1. Argudo N., Pereira J.A., Sancho J.J., Membrilla E., Pons M.J., Grande L. Prophylactic synthetic mesh can be safely used to close emergency laparotomies, even in peritonitis. Surgery. 2014;156(5):1238–1244.
    1. Albino F.P., Patel K.M., Nahabedian M.Y., Sosin M., Attinger C.E., Bhanot P. Does mesh location matter in abdominal wall reconstruction? A systematic review of the literature and a summary of recommendations. Plast. Reconstr. Surg. 2013;132(5):1295–1304.
    1. Timmermans L., de Goede B., van Dijk S.M., Kleinrensink G.J., Jeekel J., Lange J.F. Meta-analysis of sublay versus onlay mesh repair in incisional hernia surgery. Am. J. Surg. 2014;207(6):980–988.
    1. Holihan J.L., Bondre I., Askenasy E.P. Sublay versus underlay in open ventral hernia repair. J. Surg. Res. 2016;202(1):26–32.
    1. Poulose B.K., Shelton J., Phillips S. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012;16(2):179–183.
    1. Fischer J.P., Basta M.N., Krishnan N.M., Wink J.D., Kovach S.J. A cost-utility assessment of mesh selection in clean-contaminated ventral hernia repair. Plast. Reconstr. Surg. 2016;137(2):647–659.

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