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.

BACKGROUND: Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications. METHODS: One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement. DISCUSSION: The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh. TRIAL REGISTRATION: The PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018.

Surgical techniques for parastomal hernia repair: a systematic review of the literature.

BACKGROUND: Parastomal hernias are a frequent complication of enterostomies that require surgical treatment in approximately half of patients. This systematic review aimed to evaluate and compare the safety and effectiveness of the surgical techniques available for parastomal hernia repair. METHODS: Systematic review was performed in accordance with PRISMA. Assessment of methodological quality and selection of studies of parastomal hernia repair was done with a modified MINORS. Subgroups were formed for each surgical technique. Primary outcome was recurrence after at least 1-year follow-up. Secondary outcomes were mortality and postoperative morbidity. Outcomes were analyzed using weighted pooled proportions and logistic regression. RESULTS: Thirty studies were included with the majority retrospective. Suture repair resulted in a significantly increased recurrence rate when compared with mesh repair (odds ratio [OR] 8.9, 95% confidence interval [CI] 5.2-15.1; P < 0.0001). Recurrence rates for mesh repair ranged from 6.9% to 17% and did not differ significantly. In the laparoscopic repair group, the Sugarbaker technique had less recurrences than the keyhole technique (OR 2.3, 95% CI 1.2-4.6; P = 0.016). Morbidity did not differ between techniques. The overall rate of mesh infections was low (3%, 95% CI 2) and comparable for each type of mesh repair. CONCLUSIONS: Suture repair of parastomal hernia should be abandoned because of increased recurrence rates. The use of mesh in parastomal hernia repair significantly reduces recurrence rates and is safe with a low overall rate of mesh infection. In laparoscopic repair, the Sugarbaker technique is superior over the keyhole technique showing fewer recurrences.

Chronic pain after mesh repair of inguinal hernia: a systematic review.

BACKGROUND: Chronic pain is a severe complication of mesh-based inguinal hernia repair. Its perceived risk varies widely in the literature. The current objectives are to review the incidence, severity, and consequences of chronic pain and its etiologies. DATA SOURCES: A multi-database systematic search was conducted for prospective trials on mesh-based inguinal hernia repair reporting the measurement and outcome of pain at least 3 months postoperatively with a minimum follow-up of 80%. CONCLUSIONS: After mesh-based inguinal hernia repair, 11% of patients suffer chronic pain. More than a quarter of these patients have moderate to severe pain, mostly with a neuropathic origin. As a consequence of chronic pain, almost one third of patients have limitations in daily leisure activities. Chronic pain is less frequent after endoscopic repair and with the use of a light-weighted mesh.

Short-term outcome of loop ileostomy closure under local anesthesia: results of a feasibility study.

BACKGROUND: Loop ileostomy is an established technique for temporary deviation of bowel contents to avoid clinical anastomotic leakage, fistulas, or use of an inflamed colon. Anesthetic risks and postoperative complications of the closure operation result in a significant proportion of ileostomies that are never closed, factors that should be borne in mind when fashioning temporary stomas. We investigated loop ileostomy closure under local anesthesia as a way to avoid these problems. METHODS: As a feasibility study, 15 successive patients underwent closure of a loop ileostomy under local anesthesia. The patients' experience of the procedure, postoperative pain, analgesia requirements, and oral intake were prospectively evaluated. RESULTS: Procedures could be comfortably completed under safe doses of local anesthesia. Use of standard nasogastric tubes was avoided and immediately postoperatively patients were able to resume a full oral diet. Discharge was on the second postoperative day (median). Complications were paralytic ileus for two days (1 patient), anastomotic leakage (1 patient), and superficial wound infection (1 patient). CONCLUSION: Reversal of loop ileostomy can be performed safely and comfortably under local anesthesia. Postoperative results compare favorably with those of routine procedures.