Clinical trial NCT05985239: Virtual Ileostomy Versus Diverting Ileostomy
Official title: Comparing the Safety and Efficacy of Virtual Ileostomy Versus Diverting Ileostomy in Patients Underwent Total Mesorectal Excision for Rectal Cancer: a Propensity-matched Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Virtual ileostomy
Diverting ileostomy
Total mesorectal excision
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: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent total mesorectal excision for rectal cancer between September 2014 and January 2024.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
timeFrame: 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
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 total mesorectal excision 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 total mesorectal excision for rectal cancer
Locations:
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
References:
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