Virtual Ileostomy Versus Diverting Ileostomy
- Conditions
- Rectal Cancer
- Interventions
- Procedure: DIProcedure: VI
- Registration Number
- NCT05985239
- Lead Sponsor
- fan li
- 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 number of hospitalizations with virtual ileostomy versus conventional divertingileostomy after total mesorectal excision for rectal cancer.
- Detailed Description
Diverting ileostomy (DI) is a common procedure performed in patients undergoing total mesorectal excision for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 612
- Diagnosis of rectal cancer confirmed by pathology
- Age ≥ 18 years
- Lap/robot total mesorectal excision (TME) surgical procedures and colon-rectum or colon-anal anastomosis#1.anterior resection (AR/ PME), 2. low anterior resection (LAR) , 3.intersphincteric abdominoperineal resection (ISR), 4.transanal total mesorectal excision (TaTME)
- Ability to understand the nature and risks of participating in the trial
- Emergency surgery, open surgery
- ASA score >3points
- Patients with combined complete intestinal obstruction
- Long-term history of using immunosuppressants 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 before 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
- missing information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diverting ileostomy DI Laparoscopic or robotic surgery with diverting ileostomy Virtual ileostomy VI Laparoscopic or robotic surgery with virtual ileostomy
- Primary Outcome Measures
Name Time Method Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient An average of 1 year from the date of total mesorectal excision for rectal cancer until the date of when the patient's condition is stabilized without complications The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
- Secondary Outcome Measures
Name Time Method Postoperative hospitalization days Through study completion, an average of 1 year Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Readmission rates Through study completion, an average of 1 year Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
The number of hospitalizations Through study completion, an average of 1 year Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
Duration of bearing the stoma (months) Through study completion, an average of 1 year If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.
First hospitalization costs During hospitalization,approximately 7 days Patient hospitalization costs for radical resection of rectal cancer.
Total hospitalization costs Through study completion, an average of 1 year Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of low anterior resection for rectal cancer.
Trial Locations
- Locations (1)
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, China