Clinical trial NCT05985252: Virtual Ileostomy Versus Conventional Loop Ileostomy
Official title: Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Virtual ileostomy
Diverting ileostomy
Rectal Neoplasms
Rectosigmoid junction
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
timeFrame: 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 outcomes:
measure: Postoperative hospitalization days
timeFrame: Through study completion, an average of 1 year
measure: Readmission rates
timeFrame: Through study completion, an average of 1 year
measure: The number of hospitalizations
timeFrame: Through study completion, an average of 1 year
measure: Duration of bearing the stoma (months)
timeFrame: Through study completion, an average of 1 year
measure: First hospitalization costs
timeFrame: During hospitalization,approximately 7 days
measure: Total hospitalization costs
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.
timeFrame: Through study completion, an average of 1 year
measure: Patients with stoma (terminal/loop) at 6 months after initial surgery
timeFrame: 6 months from the date of low anterior resection for rectal cancer
measure: The number of participants with virtual ileostomy converted to diverting ileostomy
timeFrame: Through study completion, an average of 1 year
measure: The number of patients who required secondary abdominal surgery under general anesthesia due to complications
timeFrame: Through study completion, an average of 1 year
measure: Ghost ileostomy remove time
timeFrame: During hospitalization,approximately 7 days
measure: The number of patients with complications after low anterior resection for rectal cancer
timeFrame: Through study completion, an average of 1 year
measure: Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.
timeFrame: 6 months from the date of low anterior resection for rectal cancer
Locations:
city: Chongqing
country: China
facility: Daping hospital
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: fan li
role: PRINCIPAL_INVESTIGATOR
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