Health Condition 1: K639- Disease of intestine, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
University of Birmingham
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult patients undergoing right colectomy with or without primary anastomosis. Right colectomy is defined as ileocaecal resection or right hemicolectomy (any colonic transection with the distal resection margin proximal to the splenic flexure). 2. All patients undergoing right colectomy are eligible, including those who do not have an anastomosis and are defunctioned by a proximal stoma. 3. Procedures for any pathology, via any operative approach (open, laparoscopic, robotic or converted) are eligible. 4. Elective (surgery on a planned admission), expedited (within 48 hours), and emergency (surgery on an unplanned admission) procedures are eligible.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing more than one gastrointestinal anastomosis during the same operation. 2. In Crohnâ??s disease, additional upstream strictureoplasty or resection/anastomosis to treat disease or strictures at the same operation. 3. Simultaneous right colectomy and hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anastomotic leak within 30-days of surgery (with Day 0 as the day of surgery). The denominator for the primary outcome is the total for patients who had a primary anastomosis. The numerator is anastomotic leak, defined as a composite of either: Anastomotic leakage identified radiologically or clinically Intraperitoneal fluid collection as per the Centre for Disease Control Criteria for Organ Space infection Entero-enteric fistula identified radiologicallyTimepoint: Baseline Data Immediately Post Operative 30 day follow up post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ The denominator is the total for patients who had a primary anastomosis: â?¢ Reoperation for anastomotic leak, within 30-days â?¢ The denominator is the total for all patients: â?¢ Reoperation for any cause, within 30-days â?¢ Unplanned admission to critical care, within 30 days â?¢ Readmission within 30 days. â?¢ Post-operative length of hospital stay, up to 30-days â?¢ Mortality within 30-days. â?¢ Rate of ileostomy without anastomosis. â?¢ Rate of defunctioning ileostomy with anastomosis.Timepoint: 30 day follow up post surgery | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, China, Denmark, Egypt, Ethiopia, Germany, Greece, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Italy, Japan, Jordan, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Nigeria, Other, Pakistan, Panama, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sri Lanka, Sudan, Sweden, Syrian Arab Republic, Taiwan, Turkey, Ukraine, United Kingdom, United States of America, Yemen
Contacts
Public ContactDr Parvez David Haque
Tata Medical Center Kolkata
Outcome results
None listed