Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial.

PURPOSE: This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients. METHODS: A total of 119 women patients who suffered from obstructed defecation with associated rectocele and rectal intussusception were randomized to stapled transanal rectal resection or biofeedback training. Stapled transanal rectal resection was performed by using two circular staplers to produce transanal full-thickness rectal resection. Primary outcome was symptoms of obstructed defecation resolution at 12 months; secondary outcomes included safety, change in quality of life score, and anatomic correction of rectocele and rectal intussusception. RESULTS: Fourteen percent (8/59) stapled transanal rectal resection and 50 percent (30/60) biofeedback training patients withdrew early. Eight (15 percent) patients treated with stapled transanal rectal resection and 1 (2 percent) biofeedback patient experienced adverse events. One serious adverse event (bleeding) occurred after stapled transanal rectal resection. Scores of obstructed defecation improved significantly in both groups as did quality of life (both P < 0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P < 0.0001). Functional benefit was observed early and remained stable during the study. CONCLUSIONS: In this controlled trial, stapled transanal rectal resection was well tolerated, was more effective than biofeedback training for the resolution of obstructed defecation symptoms, and improved quality of life, with minimal risk of impaired continence. Thus, stapled transanal rectal resection offers a new treatment alternative for obstructed defecation after failure of conservative measures including biofeedback training, a noninvasive approach.

Evaluation of a 36 Gy elective node irradiation dose in anal cancer.

PURPOSE: To retrospectively analyze the efficacy of 36 Gy of elective node irradiation and report patterns of recurrence in patients with anal cancer treated by chemoradiation with the same radiotherapy (RT) treatment scheme. METHODS AND MATERIALS: Between January 1996 and December 2013, 142 patients with anal squamous cell cancer were scheduled to receive a dose of 36 Gy of elective node irradiation (ENI) to the inguinal area and whole pelvis over 4 weeks followed after a 2-week gap by a boost dose of 23.4 Gy over 17 days to the macroscopic disease. Mitomycin C combined with fluorouracil, capecitabin or cisplatin was given at day 1 of each sequence of RT. RESULTS: Disease stages were I: 3, II: 78, IIIA: 23, IIIB: 38. Compliance rates were 97.2% with RT and 87.9% with chemotherapy. After a median follow up of 48 months [3.6-192], estimated 5-year overall survival and colostomy-free survival were 75.4% and 85.3% respectively. Eleven patients (7.7%) never achieved a complete response, 15 had a local component of recurrence and 5 a regional one. One patient had failure in the common iliac node area outside the treatment fields. The inguinal control rate was 98.5%. The 5-year tumor and nodal control rates were 81.5% and 96.0%, respectively. CONCLUSION: Chemoradiation with a dose of 36 Gy ENI achieved excellent nodal control. However, it is necessary to improve the 5-year control rate of the primary tumor. Omitting the gap and using additional doses per fraction or hyper-fractionation are to be explored.

Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up.

PURPOSE: The purpose of this study was to compare the outcome of stapled hemorrhoidopexy (SH group) performed using a circular stapler with that of the Milligan-Morgan technique (MM group). The goals of the study were to evaluate the efficacy and reproducibility of stapled hemorrhoidopexy and define its place among conventional techniques. METHODS: A series of 134 patients were included at 7 hospital centers. They were randomized according to a single-masked design and stratified by center (with balancing every 4 patients). Patients were clinically evaluated preoperatively and at 6 weeks, 1 year, and a minimum of 2 years after treatment. Patients completed a questionnaire before and 1 year after surgery to evaluate symptoms, function, and overall satisfaction. RESULTS: The mean follow-up period was 2.21 years +/- 0.26 (1.89-3.07). Nine patients (7%) could not be monitored at 1 or 2 years, but 4 of these 9 nevertheless filled in the 1-year questionnaire. The patients in the SH group experienced less postoperative pain/discomfort as scored by pain during bowel movement (P < 0.001), total analgesic requirement over the first 3 days (according to the World Health Organization [WHO] class II analgesics [P = 0.002]; class III [P = 0.066]), and per-patient consumption frequency of class III analgesics (P = 0.089). A clear difference in morphine requirement became evident after 24 hours (P = 0.010). Hospital stay was significantly shorter in the SH group (SH 2.2 +/- 1.2 [0; 5.0] versus MM 3.1 +/- 1.7 [1; 8.0] P < 0.001). At 1 year, no differences in the resolution of symptoms were observed between the 2 groups, and over 2 years, the overall incidence of complications was the same, specifically fecaloma (P = 0.003) in the MM group and external hemorrhoidal thrombosis (P = 0.006) in the SH group. Impaired sphincter function was observed at 1 year with no significant difference between the groups for urgency (12%), continence problems (10%), or tenesmus (3%). No patient needed a second procedure for recurrence within 2 years, although partial residual prolapse was detected in 4 SH patients (7.5%) versus 1 MM patient (1.8%) (P = 0.194). CONCLUSION: Stapled hemorrhoidopexy causes significantly less postoperative pain. The technique is reproducible and can achieve comparable outcomes as those of the MM technique as long as the well-described steps of the technique are followed. Like with conventional surgery, anorectal dysfunction can occur after stapled hemorrhoidopexy in some patients. Its effectiveness in relieving symptoms is equivalent to conventional surgery, and the number of hemorrhoidal prolapse recurrences at 2 years is not significantly different. Hemorroidopexy is applicable for treating reducible hemorrhoidal prolapse.