Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of participants with Post-operative Ileus (POI)
研究概览
简要总结
The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is:
• If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.
Participants admitted for stoma reversal will be divided into two groups:
-
EE: Conventional Hand-sewn end-to-end anastomosis, and
-
SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:
-
HSSA: Hand-sewn side-to-side anastomosis
-
SSSA: Stapled side-to-side anastomosis
Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:
- Rates of major post-operative complications
- Rates of short-term complications (within 30 days of surgery)
- Rates of re-operation
- Post-operative length of stay in the hospital
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consent
排除标准
- •Pre-operatively diagnosed malnutrition or cachexia
- •Bleeding disorders
- •Patients undergoing stoma reversal along with a concurrent abdominal surgery
- •Rectal anastomosis
- •Use of circular stapler for anastomosis.
结局指标
主要结局
Number of participants with Post-operative Ileus (POI)
时间窗: From the day of surgery for 30 days
Number of participants with two or more episodes of nausea/vomiting, inability to tolerate oral diet over 24 hours, absence of flatus over 24 hours, or distension, and with radiologic confirmation, occurring postoperatively without spontaneous resolution
Number of participants with Anastomotic Leak
时间窗: From the day of surgery for 30 days
Number of participants with leakage of bowel contents from the anastomotic site, confirmed with imaging studies and clinical signs, such as fever \>38.5˚C, leucocytosis, elevated serum C-reactive protein, drainage of intestinal content from the drain or computed tomography findings of abscess formation around the anastomosis.
Number of participants with complications of Clavien-Dindo grade higher than 2
时间窗: From the day of surgery for 30 days
Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication.
Number of participants with Bowel Obstruction
时间窗: From the day of surgery for 30 days
Number of participants with Bowel dilatation and obstipation (inability to pass flatus as well as motion), requiring surgery for treatment, with transition point of the obstruction confirmed either radiologically or intraoperatively
次要结局
- Operating Time(Intraoperatively)
- Number of participants with Wound Infection(From the day of surgery for 30 days)
- Number of participants with Anastomotic Stricture(From the day of surgery for 30 days)
- Overall Morbidity(From the day of surgery for 30 days)
- Number of participants with Intra-abdominal Collection(From the day of surgery for 30 days)
- Number of participants with Anastomotic Bleeding(From the day of surgery for 30 days)
- Number of participants with Re-operation(From the day of surgery for 30 days)
- Number of participants with Organ Dysfunction for each individual organ(From the day of surgery for 30 days)
研究者
Tanmay Agarwal
Junior Resident, Principal Investigator
Sawai Mansingh Medical College