NCT05985252

Virtual Ileostomy Versus Conventional Loop Ileostomy

Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.

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 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.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Virtual ileostomy	Laparoscopic or robotic surgery with virtual ileostomy
PROCEDURE	Diverting ileostomy	Laparoscopic or robotic surgery with diverting ileostomy

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2025-12-31
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

2 sites across 1 country: China