Prospective, Randomised European Multicentric Study, Comparing Enteral Stent Followed by Elective Surgery Versus Emergency Surgical Treatment in Malignant Colonic Obstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- incidence of postoperative complications
研究概览
简要总结
The purpose of this study is to verify whether stent positioning for malignant obstruction of the colon and rectum followed by elective surgery allows reduction of postoperative complications and hospital stay without worsening of evolution of the neoplastic illness, compared to emergency surgery.
Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be postoperative mortality, length of hospital stay, need for analgesia.
详细描述
Introduction & background In emergency surgery, although surgical and resuscitation techniques were improved, the postoperative complications and mortality rates are still high and however higher than for those patients that underwent to elective surgery (1-3). Using a Metallic prosthesis stent in an obstructed colon allows to transform an emergency surgical case into an elective surgery case. This allows to restore the bowel transit and to operate in elective condition reducing morbidity, mortality and the need of an enterostomy (4-10).
Although there are recent outcomes on literature about use of a decompressive stent before surgery in obstructed patients from malignant colic tumours, there are no prospective and randomised studies were stent positioning followed by elective surgery is compared with emergency surgery.
Study design Prospective, randomized multicentric clinical trial where samples are patients with emergency room diagnosis of obstructing colonic neoplasm.
Once informed and obtained consent, patients will be included in the study and randomized in one of the two branches of the study: A.- enteral stent positioning followed by second time resection in the same hospital stay. B.- emergency surgical treatment consisting in Hartmann operation or resection with same time anastomosis. Results from transit reconstruction in patients underwent Hartmann operation will be considered in the study.
Short term clinical evolution control in order to determine postoperative morbility and mortality, hospital stay.
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
- •malignant colonic obstruction localized between splenic flexure and 15 cm from anal margin diagnosed by CTScan.
- •Possibility of endoscopy and stent location during next 24 h after diagnostic.
- •Clinical occlusion to gas and faeces.
- •Informed consent obtained from the patient or from a relative in case of inability.
排除标准
- •Bowel perforation diagnosed by clinical exploration and complementary studies.
- •Associated pathologies contraindicating general anaesthesia and/or haemodynamic instability.
- •Impossibility to gain a valid informed consent or refusal from the patient.
- •Patients with multiple liver metastases diagnosed by CTScan at the moment of diagnostic and not considered operable with curative intention following the standards of every center.
结局指标
主要结局
incidence of postoperative complications
时间窗: 60 days
次要结局
- percentage of complications related to stent positioning(at stent positioning)
- postoperative mortality(30 days)
- quality of life and survival(3 years)
- success percentage of stent positioning in emergency(at stent positioning)
- length of hospital stay(3 months)
- cost differences(3 months)
- oncological results (local and distant recurrence rate)(3 years)
研究者
Alberto Arezzo
Assistant Professor of Surgery
European Association for Endoscopic Surgery