Stapled Trans-anal Rectal Resection Using Single Versus Double Stapler in Surgical Management of Obstructed Defecation: A Randomised Clinical Trial

The stapled trans-anal rectal resection (STARR) procedure has been widely used, with reports of favourable outcomes and significant complications. This study evaluated the safety and efficacy of the procedure using a single stapler versus a double stapler for the management of obstructed defecation syndrome (ODS). This randomised, single-blinded, parallel-group clinical trial involved 48 patients with rectal intussusception who were scheduled for STARR surgery. The patients were randomised into two groups. In the single STARR group, 24 patients underwent STARR operation using a single PPH-03™ stapler anteriorly, while in the double STARR group, another 24 patients underwent STARR operation using double PPH-03™ staplers anteriorly and posteriorly. The primary outcome was the ODS score at 3 and 6 months postoperatively. Secondary outcomes included the operative time, pain, incidence of bleeding, defecation urgency, flatus incontinence and the cost. Both single and double STARR procedures improved postoperative ODS scores compared to preoperative assessment with comparable reduction in the scores at three and six months postoperatively (p = 0.211 and 0.282, respectively). The operative time, the incidence of defecation urgency and the financial costs were significantly reduced in the single STARR compared to the double STARR (30.8 standard deviation (SD) 3.1 versus 44.6 SD4.0 min, 8.3% versus 33.3%, 14,991.67 SD704.59 versus 30,516.67 SD905.38 Egyptian pounds, p < 0.001, 0.034 and < 0.001, respectively). Improvement of obstructed defecation syndrome score was comparable in the single- and double-stapled trans-anal rectal resection procedures. However, the single procedure offers shorter operative time, less postoperative urgency and lower cost. ClinicalTrials.gov identifier: PACTR202403582262947.