Virtual Ileostomy Versus Diverting Ileostomy

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Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: DI; Procedure: VI

Study type: Observational

Funder types: Other

Identifiers

NCT05985239

VI vs. DI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 612 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

612 participants in 2 patient groups

Virtual ileostomy

Description:

Laparoscopic or robotic surgery with virtual ileostomy

Treatment:

Procedure: VI

Diverting ileostomy

Description:

Laparoscopic or robotic surgery with diverting ileostomy

Treatment:

Procedure: DI