Transrectal Vacuum Assisted Drainage: A NEW METHOD OF TREATING ANASTOMOTIC LEAKAGE AFTER RECTAL RESECTION. A Prospective Randomized Multicenter Study in Cooperation With "The Danish Colorectal Cancer Group"
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Healing time of the anastomotic leakage
研究概览
简要总结
Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage.
Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.
The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically significant* anastomotic leakage after intended curative rectal resection (LAR) for rectal cancer with primary anastomosis.
- •Patients whose operation did not include ileostomy must have surgery to create a stoma within two days after beginning of the vacuum therapy and before randomization. Anastomotic leakage must have been diagnosed within 21 days of the primary operation.
- •Patients with and without preoperative radiation therapy may participate.
- •Groups will be formed accordingly, because patients who had preoperative radiation therapy heal more slowly.
- •Patients with anastomotic leakage (diagnosed by endoscopic or radiology techniques) and clinical signs and symptoms indicating a health impairment (fever, pain, elevated creatinine levels).
- •Anastomotic leakage after rectal cancer surgery
排除标准
- •Informed consent
- •Age < 18 years
- •Acute surgery
- •Leakage diagnosed more than 21 days after the primary operation
- •Patient does not consent to temporary ileostomy
- •Anastomosis technically inaccessible for vacuum-assisted drainage
- •Small intestine visible in abscess cavity
- •Residual cancer tissue in the pelvic cavity
- •Suspicion of fistulation between the abscess cavity and internal genitalia, urinary tract system, or small intestines.
结局指标
主要结局
Healing time of the anastomotic leakage
时间窗: 1 year
次要结局
- Salvage surgery (abdominal reoperation with debridement of anastomosis)(1 month)
- Duration of fever and antibiotic treatment(2 months)
- Duration of hospital stay(2 monts)
- Number of visits in the outpatient clinic / number of sponge changes(8 weeks)
- Functional result, defined as +/- closure of temporary ileostomy(2 years)
- Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)(2 years)