A clinical trial to study the effects of cleaning the bowel of fecal matter by administering oral cleansing agents before operation on the septic complications after the operatio
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectumHealth Condition 2: null- post rectal surgery for rectal malignancy
- Registration Number
- CTRI/2017/10/010177
- Lead Sponsor
- Department of Gastroenterology Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
All patients undergoing
1) elective anterior resection for adenoma or malignancy diagnosed by colonoscopic biopsy at least 15 cms from the anal verge requiring
2) 18-85 years with an
3) ASA grade of I, II or III
Cases presenting as
1)Acute obstruction
2)peritonitis
3)Inflammatory bowel disease of the rectum
4)Diverticulitis requiring anterior resection with concomitant pelvic abscess or pericolic abscess
5)Those requiring intraoperative colonoscopy
6)Any case undergoing rectal surgery without a rectal anastomosis
7)Participants who were unable to drink PEG
8)Patient who refused to be randomized
9)Severe systemic llnesses like immunosuppression, human immunodeficiency virus infection and liver cirrhosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Anastomotic leakageTimepoint: within 30 days of surgery
- Secondary Outcome Measures
Name Time Method Major wound infection, <br/ ><br>minor wound infection, <br/ ><br>intraabdominal collections, <br/ ><br>feculent or purulent discharge from drains <br/ ><br>duration of drain retention, <br/ ><br>resumption of oral diet, <br/ ><br>reoperation/intervention, <br/ ><br>discharge day, <br/ ><br>extraabdominal infectious complications and <br/ ><br>extraabdominal non infectious complications <br/ ><br>death â??within 30 days <br/ ><br>Timepoint: within 30 days of surgery