Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients: Short-term Outcomes and Microbiota (BUTYCLO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Postoperative complication rate
研究概览
简要总结
Low Anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer.
Ileostomy reversal performed in a second stage carries a high burden of postoperative complications.
Terminal ileum and colon dysfunction during bowel disconnection could negatively influence postoperative morbimortality after loop ileostomy reversal in Rectal Cancer patients.
Colonic microflora performs anaerobic breakdown of dietary fibre that reaches the gut in regular patients without ileostomy. One of the short-chain fatty acids (SCFAs) produced by bacteria is butyrate, the preferred substrate to be oxidized by colonocytes.
The effects of butyrate irrigations before ileostomy closure on colonic mucosa will be studied in 45 rectal cancer patients.
The effects of butyrate irrigation trough the efferent limb of loop ileostomy before its closure will be compared to the saline and non-irrigations group.
Short term outcomes, colonic microbiota composition and functional outcomes will be evaluated after ileostomy reversal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
1 treatment arm open label
1 treatment arm double-blind
1 treatment arm double-blind
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 over 18 years of age
- •Patients waiting for an elective ileostomy reversal after Rectal cancer surgical treatment
排除标准
- •Inflammatory bowel disease
- •Abnormal preoperative findings trough rectoscopy or CT-enema scan that precluded a safe ileostomy closure
- •Ileal pouch, poor treatment compliance
- •Pregnancy or lactation
- •Unwillingness to use adequate contraception throughout the study period
- •Combined surgeries
- •The impossibility to understand the informed consent.
研究组 & 干预措施
Saline irrigations
Saline irrigations trough the efferent limb of loop ileostomy
干预措施: Irrigations trough the efferent limb of loop ileostomy (Drug)
Butyrate irrigations
Butyrate irrigations trough the efferent limb of loop ileostomy
干预措施: Irrigations trough the efferent limb of loop ileostomy (Drug)
结局指标
主要结局
Postoperative complication rate
时间窗: Within 90 days after surgery
Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as: Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.
Length of hospital stay (number of days)
时间窗: Up to 4 weeks
Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge.
次要结局
- Diversion colitis evaluation trough rectoscopy in colonic mucosa(At 5-weeks before surgery, At day before surgery)
- Identification of microbiota modifications in colonic mucosa after irrigations(At 5-weeks before surgery, At day before surgery)
- Quality of life assessed with Short-Form 36 (SF-36) questionnaire(At hospital discharge and at 1 and 3 months after surgery)
- Anorectal functional outcome assessed by Colorectal Functional Outcome Questionnaire (COREFO) questionnaire(At hospital discharge and at 1 and 3 months after surgery)
研究者
Núria Gómez, MD
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta