Virtual Ileostomy Versus Conventional Loop Ileostomy

Study Overview
=================
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 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.

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

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Virtual ileostomy
* Procedure: Diverting ileostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual ileostomy<br>Laparoscopic or robotic surgery with virtual ileostomy | Procedure: Virtual ileostomy<br>* Laparoscopic or robotic surgery with virtual ileostomy<br>|
| Active Comparator: Diverting ileostomy<br>Laparoscopic or robotic surgery with diverting ileostomy | Procedure: Diverting ileostomy<br>* Laparoscopic or robotic surgery with diverting ileostomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient | 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. | An average of 1 year from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospitalization days | 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. | Through study completion, an average of 1 year | 
| Readmission rates | 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. | Through study completion, an average of 1 year | 
| The number of hospitalizations | 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. | Through study completion, an average of 1 year | 
| Duration of bearing the stoma (months) | 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. | Through study completion, an average of 1 year | 
| First hospitalization costs | Patient hospitalization costs for radical resection of rectal cancer. | During hospitalization,approximately 7 days | 
| Total hospitalization costs | 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. | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual ileostomy, Diverting ileostomy, Rectal Neoplasms, Rectosigmoid junction