Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy

BACKGROUND: Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. OBJECTIVE: The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. DESIGN: This is a prospective, multicenter, randomized controlled clinical trial. SETTINGS: This study was conducted at 2 university and 3 central Finnish hospitals. PATIENTS: From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. INTERVENTIONS: In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. MAIN OUTCOME MEASURES: The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. RESULTS: Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. LIMITATIONS: The study was limited by its small size and short follow-up time. CONCLUSIONS: Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after laparoscopic abdominoperineal resection. However, prophylactic mesh repair was associated with significantly lower risk of clinically detected parastomal hernia.

[1]  J. Fleshman,et al.  A Prospective, Multicenter, Randomized, Controlled Study of Non-cross-linked Porcine Acellular Dermal Matrix Fascial Sublay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies , 2014, Diseases of the colon and rectum.

[2]  L. Feldman,et al.  Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. , 2014, Journal of the American College of Surgeons.

[3]  B. Hansson Parastomal hernia: treatment and prevention 2013; where do we go from here? , 2013, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[4]  M. Śmietański,et al.  European Hernia Society classification of parastomal hernias , 2013, Hernia.

[5]  M. Thaha,et al.  The persistent challenge of parastomal herniation: a review of the literature and future developments , 2013, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[6]  R. Bleichrodt,et al.  PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial , 2012, Trials.

[7]  R. Bleichrodt,et al.  The laparoscopic modified Sugarbaker technique is safe and has a low recurrence rate: a multicenter cohort study , 2012, Surgical Endoscopy.

[8]  B. Chaudhary,et al.  A systematic review on the use of prophylactic mesh during primary stoma formation to prevent parastomal hernia formation , 2012, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[9]  M. López-Cano,et al.  Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial , 2012, Hernia.

[10]  M. Ujiki,et al.  Laparoscopic modified Sugarbaker technique results in superior recurrence rate , 2012, Surgical Endoscopy.

[11]  C. Bhan,et al.  Stapled mesh stoma reinforcement technique (SMART)--a procedure to prevent parastomal herniation. , 2011, Annals of the Royal College of Surgeons of England.

[12]  L. Israelsson,et al.  Laparoscopic stoma formation with a prophylactic prosthetic mesh , 2010, Hernia.

[13]  L. Israelsson,et al.  Experiences with a Prophylactic Mesh in 93 Consecutive Ostomies , 2010, World Journal of Surgery.

[14]  M. Bailey,et al.  Prospective Audit of Parastomal Hernia: Prevalence and Associated Comorbidities , 2010, Diseases of the colon and rectum.

[15]  E. Espín-Basany,et al.  Prosthetic Mesh in Parastomal Hernia Prevention. Laparoscopic Approach , 2009, Diseases of the colon and rectum.

[16]  S. Navarro-Soto,et al.  Randomized, Controlled, Prospective Trial of the Use of a Mesh to Prevent Parastomal Hernia , 2009, Annals of surgery.

[17]  L. Israelsson,et al.  Preventing Parastomal Hernia with a Prosthetic Mesh: A 5-Year Follow-up of a Randomized Study , 2008, World Journal of Surgery.

[18]  D. Berger Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay mesh (Dynamesh IPST®) , 2008, Hernia.

[19]  L. Israelsson Preventing and Treating Parastomal Hernia , 2005, World journal of surgery.

[20]  Ph.D. Leif A. Israelsson M.D. Preventing and Treating Parastomal Hernia , 2005, World Journal of Surgery.

[21]  L. Israelsson,et al.  Preventing parastomal hernia with a prosthetic mesh. , 2004, Archives of surgery.

[22]  L. Israelsson,et al.  Randomized clinical trial of the use of a prosthetic mesh to prevent parastomal hernia , 2004, The British journal of surgery.