Paolo Boccasanta1, Marco Venturi, Giancarlo Roviaro. 1. Ospedale Maggiore Policlinico, Ca'Granda Istituto di Ricovero e Cura a Carattere Scientifico Foundation, Milan 1st Department of General Surgery, University of Milan, Milan, Italy. pboccasanta@tiscali.it
Abstract
PURPOSE: A randomized study was conducted to compare the clinical and functional outcomes of the stapled transanal rectal resection, using the traditional 2 circular staplers and a new, curved stapler device in patients with obstructed defecation caused by rectal intussusception and rectocele. Stapled transanal rectal resection gives good midterm results in patients with obstructed defecation syndrome, but the limited capacity of the casing of the circular stapler and the impossibility to control the positioning of the rectal wall and the firing of staples may result in incomplete removal of the prolapsed tissues, or serious complications. The new curved multifire stapler could avoid these drawbacks. METHODS:From January to December 2006, 100 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography, and randomly assigned to 2 groups: 50 patients underwentstapled transanal rectal resection with 2 traditional circular staplers (STARR group) and 50 had the same operation with a new, curved multifire stapler (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and colpocystodefecography, with the recurrence rate as the primary outcome measure. RESULTS:Recurrence rates at 3 years were 12.0% in STARR group and 0 in the TRANSTAR group (P = .035). Operating time was significantly shorter in the STARR group (P = .008). Complications were 2 bleeds (4%) in the STARR group and 1 tear of the vagina in the TRANSTAR group. The incidence of fecal urgency was 34.0% in the STARR group and 14.0% in the TRANSTAR group (P = .035). All symptoms and defecographic parameters significantly improved after the operation (P < .001) without differences between groups. CONCLUSIONS: The curved Contour Transtar stapler device did not appear to offer significant advantages over the traditional PPH-01 device during the operation or in the clinical and functional outcomes. However, the lower incidence of fecal urgency and recurrences might justify the higher cost of the new stapler.
RCT Entities:
PURPOSE: A randomized study was conducted to compare the clinical and functional outcomes of the stapled transanal rectal resection, using the traditional 2 circular staplers and a new, curved stapler device in patients with obstructed defecation caused by rectal intussusception and rectocele. Stapled transanal rectal resection gives good midterm results in patients with obstructed defecation syndrome, but the limited capacity of the casing of the circular stapler and the impossibility to control the positioning of the rectal wall and the firing of staples may result in incomplete removal of the prolapsed tissues, or serious complications. The new curved multifire stapler could avoid these drawbacks. METHODS: From January to December 2006, 100 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography, and randomly assigned to 2 groups: 50 patients underwent stapled transanal rectal resection with 2 traditional circular staplers (STARR group) and 50 had the same operation with a new, curved multifire stapler (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and colpocystodefecography, with the recurrence rate as the primary outcome measure. RESULTS: Recurrence rates at 3 years were 12.0% in STARR group and 0 in the TRANSTAR group (P = .035). Operating time was significantly shorter in the STARR group (P = .008). Complications were 2 bleeds (4%) in the STARR group and 1 tear of the vagina in the TRANSTAR group. The incidence of fecal urgency was 34.0% in the STARR group and 14.0% in the TRANSTAR group (P = .035). All symptoms and defecographic parameters significantly improved after the operation (P < .001) without differences between groups. CONCLUSIONS: The curved Contour Transtar stapler device did not appear to offer significant advantages over the traditional PPH-01 device during the operation or in the clinical and functional outcomes. However, the lower incidence of fecal urgency and recurrences might justify the higher cost of the new stapler.