Status:
UNKNOWN
Virtual Ileostomy Versus Conventional Loop Ileostomy
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the numb...
Detailed Description
Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior resection for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI re...
Eligibility Criteria
Inclusion
- Pathologically confirmed low to intermediate level rectal cancer, with the lower margin of anastomosis \<10cm from the anus.
- age ≥18 years and ≤80 years.
- the surgical procedure is anterior rectal resection (LAR).
- intraoperative virtual or conventional ileostomy was performed.
Exclusion
- BMI \>30 kg/m².
- ASA score \>3.
- Patients with coexisting complete intestinal obstruction.
- History of long-term use of immunosuppressive drugs or glucocorticoids.
- Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months prior to the procedure.
- chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min).
- Intraoperative combined multi-organ resection.
- Combined cirrhosis of the liver.
- Intraoperative findings of incomplete anastomosis and positive insufflation test.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05985252
Start Date
October 1 2023
End Date
December 31 2025
Last Update
August 14 2023
Active Locations (2)
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1
Daping hospital
Chongqing, China, 400042
2
Daping Hospital, Third Military Medical University
Chongqing, China