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.