Randomized Controlled Clinical Trial: Endoluminal Loco-regional Resection (ELRR) by Transanal Endoscopic Microsurgery (TEM) Versus Laparoscopic Total Mesorectal Excision (LTME) in it2n0m0 Small Low Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 主要终点
- oncological result in term of local and/or systematic recurrence
研究概览
简要总结
The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.
详细描述
From April 1997 to April 2004, patients with cT2 rectal cancer and no suspicion for positive lymph-nodes or distant metastases (cN0 M0) were enrolled in this study.
History, routine laboratory tests including tumour markers, digital examination to evaluate tumour fixation and sphincter tone, clinical evaluation, were recorded for each patient in a data base.
At admission, staging included: 1) endorectal ultrasound (EUS) 2) rigid rectoscopy and tumour biopsies; 3) total colonoscopy with vital dye staining of the rectum and 6-8 standard biopsies of normal mucosa at a distance of approximately 1 cm around the tumour with India ink tattooing of biopsy sites; 4) helical Total Body Computerized Tomography (CT), and 5) pelvic magnetic resonance imaging (MRI). Rigid rectoscopy was performed in order to measure the exact distance of the tumour from the anal verge and to select the most appropriate patient's position on the operative table in case of TEM surgery.
Positive lymph-node status at imaging was established according to the following criteria:
- at EUS, diameter > 0.8 cm, circular or irregular shape, hypervascularization at colour Doppler and hypoechogenicity.
- at CT and MRI, diameter of > 0.8 cm, circular or irregular shape. All patients with suspicious nodes or contradictory response at EUS, CT or MRI T staging were not enrolled in the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor located within 6 cm from the anal verge
- •Tumor diameter not larger than 3 cm, and staged as iT2, N0, G1-2
排除标准
- •Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4
结局指标
主要结局
oncological result in term of local and/or systematic recurrence
时间窗: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation
To evaluate local and/or systematic recurrence, all patients were followed up prospectively by clinical examination, measurement of tumour markers and sigmoidoscopy every 3 months for the first 3 years, and every 6 months thereafter. Whole-body CT and pelvic MRI were repeated every 6 months for the first 5 year. All patients had a minimum follow-up of 5 years.
次要结局
- Morbidity(participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group)
- operative time(operative time)
- blood loss(during time of operation)
- analgesic use(participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group)
- 30 day mortality(at 30 days from operation)
- hospital stay(participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group)
- cancer-related mortality(3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation)
研究者
Lezoche Emanuele
Professor
University of Roma La Sapienza