Authors' objectives:

To determine the safety, clinical effectiveness and cost-effectiveness of circular stapled haemorrhoidopexy (SH) for the treatment of
haemorrhoids.

Authors' results and conclusions: The clinical effectiveness review included 27 RCTs (n = 2279; 1137 SH; 1142 CH). All had some methodological flaws; only two reported recruiting patients with second, third and fourth degree haemorrhoids, and 37% reported using an appropriate method of randomisation and/or allocation concealment. In the early postoperative period 95% of trials reported less pain following SH; by day 21 the pain reported following SH and CH was minimal, with little difference between the two techniques. Significantly fewer patients had unhealed wounds at 6 weeks following SH [odds ratio (OR) 0.08, 95% confidence interval (CI) 0.03 to 0.19, p < 0.001]. Residual prolapse was more common after SH (OR 3.38, 95% CI 1.00 to 11.47, p = 0.05, nine RCTs, results of a sensitivity analysis). There was no difference between SH and CH in the incidence of bleeding or postoperative complications. SH resulted in shorter operating times, hospital stay, time to first bowel movement and return to normal activity. In the short term (between 6 weeks and a year) prolapse was more common after SH (OR 4.68, 95% CI 1.11 to 19.71, p = 0.04, six RCTs). There was no difference in the number of patients complaining of pain between SH and CH. In the long term (1 year and over), there was a significantly higher rate of prolapse after SH (OR 4.34, 95% CI 1.67 to 11.28, p = 0.003, 12 RCTs). There was no difference in the number of patients experiencing pain, or the incidence of bleeding, between SH and CH. There was no difference in the total number of reinterventions, or reinterventions for pain, bleeding or complications, between SH and CH. Significantly more reinterventions were undertaken after SH for prolapse at 12 months or longer (OR 6.78, 95% CI 2.00 to 23.00, p = 0.002, six RCTs). Overall, there was no statistically significant difference in the rate of complications between SH and CH.

Authors' recommendations: SH was associated with less pain in the immediate postoperative period, but a higher rate of residual prolapse, prolapse in the longer term and reintervention for prolapse. There was no clear difference in the rate or type of complications associated with the two techniques and the absolute and relative rates of recurrence and reintervention for both are still uncertain. CH and SH had very similarcosts and QALYs, the cost of the staple gun being offset by savings in hospital stay. Should the price of the gun change, the conclusions of the economic analysis may also change. Some training may be required in the use of the staple gun; this is notexpected to have major resource implications. Given the currently available clinical evidence and the results of the economic analysis, the decision as to whether SH or CH is conducted could primarily be based on the priorities and preferences of the patient and surgeon. An adequately powered, good-quality RCT is required, comparing SH with CH, recruiting patients with second, third and fourth degreehaemorrhoids, and having a minimum follow-up period of 5 years to ensure an adequate evaluation of the reintervention rate. Other areas for research are the effectiveness of SH in patients with fourth degree haemorrhoids and patients with co-morbid conditions, the reintervention rates for all treatments for haemorrhoids, utilities of patients up to 6 months postoperatively, the trade-offs of patients for shortterm pain versus long-term outcomes, and the ability of SH to reduce hospital stays in a real practice setting.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1544

Year Published: 2008

URL for published report: n/a

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk