Klarenbeek Bastiaan R, Veenhof Alexander A F A, de Lange Elly S M, Bemelman Willem A, Bergamaschi Roberto, Heres Piet, Lacy Antonio M, van den Broek Wim T, van der Peet Donald L, Cuesta Miguel A
Department of Surgery, VU medical centre, Amsterdam, The Netherlands.
BMC Surg. 2007 Aug 3;7:16. doi: 10.1186/1471-2482-7-16.
Diverticulosis is a common disease in the western society with an incidence of 33-66%. 10-25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger (< 50 years) patient. Open sigmoid resection is still the gold standard, but laparoscopic colon resections seem to have certain advantages over open procedures. On the other hand, a double blind investigation has never been performed. The Sigma-trial is designed to evaluate the presumed advantages of laparoscopic over open sigmoid resections in patients with symptomatic diverticulitis.
Indication for elective resection is one episode of diverticulitis in patients < 50 years and two episodes in patient > 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy. It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patient's notes. Primary endpoints are the postoperative morbidity and mortality. We divided morbidity in minor (e.g. wound infection), major (e.g. anastomotic leakage) and late (e.g. incisional hernias) complications, data will be collected during hospital stay and after six weeks and six months postoperative. Secondary endpoints are the operative and the postoperative recovery data. Operative data include duration of the operation, blood loss and conversion to laparotomy. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire) and duration of hospital stay.
The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.
憩室病在西方社会是一种常见疾病，发病率为33% - 66%。其中10% - 25%的患者会发展为憩室炎。为了避免高风险的急诊手术，建议老年患者在发生两次憩室炎后或年轻患者（<50岁）发生一次憩室炎后进行择期乙状结肠切除术。开放乙状结肠切除术仍是金标准，但腹腔镜结肠切除术似乎比开放手术有某些优势。另一方面，从未进行过双盲调查。西格玛试验旨在评估腹腔镜乙状结肠切除术相对于开放乙状结肠切除术在有症状憩室炎患者中的假定优势。
择期切除的指征为50岁以下患者发生一次憩室炎，50岁以上患者发生两次憩室炎，或因既往憩室炎发作导致狭窄引起进行性腹部不适。通过CT扫描、钡剂灌肠和/或结肠镜检查确诊。要求参与的外科医生至少进行过15例腹腔镜和开放乙状结肠切除术。开放切除术通过正中剖腹术进行，腹腔镜切除术通过4或5个套管进行。切除有浆膜改变或硬结的乙状结肠和结肠，并进行无张力吻合。完成任何一种手术后，使用不透明敷料，覆盖从脐上10厘米至耻骨。手术细节将与患者病历分开保存。主要终点是术后发病率和死亡率。我们将发病率分为轻微（如伤口感染）、严重（如吻合口漏）和晚期（如切口疝）并发症，数据将在住院期间以及术后六周和六个月收集。次要终点是手术和术后恢复数据。手术数据包括手术持续时间、失血量和中转开腹情况。术后恢复包括恢复正常饮食、疼痛、镇痛药使用、总体健康状况（SF - 36问卷）和住院时间。
西格玛试验是一项前瞻性、多中心、双盲、随机研究，旨在确定腹腔镜乙状结肠切除术在有症状憩室炎患者中的作用。
