No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer

Not Applicable

Not yet recruiting

• Conditions: Rectal Neoplasms
• Interventions: Procedure: No ileostomy; Procedure: Ghost ileostomy

• Registration Number: NCT06225609
• Lead Sponsor: fan li

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 group versus no ileostomy group after total mesorectal excision for rectal cancer.

Detailed Description

So far, there are no relevant reports on ghost ileostomy among the Asian population, and all studies are small sample studies.In the past decades, with the advent of circular stapling devices, many middle and low rectal cancers have chosen new sphincter-saving procedures (such as ISR and Ta TME). Nevertheless, when the incidence rate of AL remains high, is diverting ileostomy applicable? Is ghost ileostomy applicable to rectal cancer in the context of new surgical procedures such as pelvic floor reconstruction, perineal drainage, anastomotic reinforcement and robotic surgery? Is this delayed stoma safe and feasible with the increase of preoperative neoadjuvant therapy? Therefore, our study proposes to summarize the review of the complications of GI and no stoma to explore the safety and effectiveness of GI in clinical practice.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Pathologically confirmed rectal cancer.
• age ≥18 years and ≤80 years.
• intraoperative ghost ileostomy or no stoma was performed.

Exclusion Criteria

• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No ileostomy	No ileostomy	Laparoscopic or robotic surgery with no ileostomy
Ghost ileostomy	Ghost ileostomy	Laparoscopic or robotic surgery with ghost ileostomy

Primary Outcome Measures

Name	Time	Method
Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient	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	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.

Secondary Outcome Measures

Name	Time	Method
Readmission rates	Through study completion, an average of 1 year	Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
The number of hospitalizations	Through study completion, an average of 1 year	Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the number of hospitalizations after total mesorectal excision for rectal cancer. If the ghost ileostomy and no stoma groups required bedside or secondary surgery for diverting ileostomy due to complications, record the number of hospitalizations due to complications and/or reoperation since the data of total mesorectal excision for rectal cancer.
Postoperative hospitalization days	Through study completion, an average of 1 year	If the ghost ileostomy group required bed rest or a second surgery for ileostomy due to complications or no stoma group required a second surgery due to complications, the number of days of hospitalization due to complications and/or reoperation since total mesorectal excision for rectal cancer was recorded.
First hospitalization costs	During hospitalization,approximately 7 days	Patient hospitalization costs for total mesorectal excision of rectal cancer.
Total hospitalization costs	Through study completion, an average of 1 year	Patients in the ghost ileostomy and no stoma groups who did not have a second surgery due to complications recorded the costs total mesorectal excision for rectal cancer, if the ghost ileostomy and no stoma groups 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 total mesorectal excision for rectal cancer.