Improved Clinical Outcomes With a New Contour-Curved Stapler in the Surgical Treatment of Obstructed Defecation Syndrome: A Mid-Term Randomized Controlled Trial

BACKGROUND: Stapled transanal rectal resection has become the primary surgical procedure for surgical treatment of obstructed defecation syndrome caused by rectocele or rectal intussusception. The procedure is generally performed with 2 circular staplers. Recently, a dedicated contour-curved stapler was developed. OBJECTIVE: This study was designed to compare the effects of these stapler types on relief of symptoms. DESIGN AND SETTING: A randomized controlled trial was conducted at a regional referral center in Naples, Italy. PATIENTS: Patients with obstructed defecation syndrome and rectocele or rectal intussusception, treated from November 2005 through September 2007. INTERVENTIONS: Participants were randomly assigned to undergo stapled transanal rectal resection with 2 circular staplers or the contour-curved stapler. MAIN OUTCOME MEASURES: The primary end point was success rate at 24 months, defined by symptom improvement on an obstructed defecation syndrome scale. Secondary end points included success rate at 12 months, Agachan-Wexner constipation score, and rates of early and late complications at 12 and 24 months. RESULTS: Of 198 patients evaluated, 63 patients (31.8%) satisfied criteria. Follow-up data were available for 61 patients: 30 patients (28 women) in the circular stapler group (mean age, 53; range, 41-75 years) and 31 (29 women) in the contour-curved stapler group (mean age, 55; range, 38-69 years). At 24-month follow-up, success was achieved in 21 patients (70.0%) with the circular staplers and in 27 (87.0%) with the contour-curved stapler (P = .10). Symptom scores improved significantly in both groups from baseline to 12 months (P < .0001). Improvement was maintained in the contour-curved stapler group: mean score, 5.0 (SD, 1.6) at 12 months and 5.5 (1.5) at 24 months (P = .20). In the circular stapler group, symptom scores worsened from 4.5 (1.5) at 12 months to 9.0 (1.3) at 24 months (P < .0001). At 24 months, the groups differed significantly in symptom scores (P < .0001) and constipation scores (P = .03). No significant differences were seen in duration of postoperative hospital stay or rate of early or late complications. CONCLUSIONS: Stapled transanal rectal resection with either circular or contour-curved staplers can achieve relief of symptoms in patients with obstructed defecation syndrome. The contour-curved stapler appears to result in more stable clinical results over time.