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

fan li

Status: Not yet enrolling

Conditions: Rectal Neoplasms

Treatments: Procedure: No ileostomy; Procedure: Ghost ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06225609

Ghost 002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Ghost ileostomy

Experimental group

Description:

Laparoscopic or robotic surgery with ghost ileostomy

Treatment:

Procedure: Ghost ileostomy

No ileostomy

Active Comparator group

Description:

Laparoscopic or robotic surgery with no ileostomy

Treatment:

Procedure: No ileostomy