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Randomized clinical trial comparing LigaSure haemorrhoidectomy with open diathermy haemorrhoidectomy.

ABSTRACT: BACKGROUND: Milligan-Morgan excision haem-orrhoidectomy remains a very popular treatment modality for third and fourth degree haemorrhoids due to its cost effectiveness and good long-term results. The LigaSure tissue-sealing device is an alternative technique used in haemorrhoidectomy that has been shown to produce favourable results. The aim of this study was to assess the effectiveness of the LigaSure tissue sealing device in comparison with conventional diathermy haemorrhoidectomy. METHODS: A prospective clinical trial was conducted. Patients with newly diagnosed haemorrhoids requiring haemorrhoidectomy were randomized to either LigaSure haemorrhoidectomy or diathermy haemorrhoidectomy. Surgical technique and postoperative care was standardized. Outcome measures were operative time and bleeding, postoperative pain (measured on a visual analogue scale) and rate of wound healing. RESULTS: We randomized 44 patients, 22 to LigaSure and 22 to diathermy; 43 patients were evaluated. They were aged between 19 and 71 years. There were no differences in patient demographics or type of haemorrhoid being operated on. LigaSure haemorrhoidectomy had a significantly lower mean operative time and intraoperative bleeding. At 3 weeks after surgery, haemorrhoidectomy performed with LigaSure had an odds ratio for complete epithelialization of 3.1 over diathermy (95% CI 1.2-8.2). There was no difference in postoperative pain. CONCLUSION: LigaSure haemorrhoidectomy is superior to diathermy for open haemorrhoidectomy.

SUBMITTER: Tan KY

PROVIDER: S-EPMC2780654 | biostudies-other | 2008 Jun

REPOSITORIES: biostudies-other

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Project description:BackgroundOpen radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk.ObjectiveTo compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques.Design, setting, and participantsA prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively.InterventionStandard ORC or RARC with PLND; all urinary diversions were performed via an open approach.Outcome measurements and statistical analysisPrimary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score.Results and limitationsThe trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings.ConclusionsThis trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique.Patient summaryOf 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups.Trial registrationClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.

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Randomized clinical trial comparing LigaSure haemorrhoidectomy with open diathermy haemorrhoidectomy.

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