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

Last updated: January 17, 2024
Sponsor: fan li
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colorectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

Ghost ileostomy

No ileostomy

Clinical Study ID

NCT06225609
Ghost 002
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 cardiacfunction ≥ grade 2.
  • Patients with a history of myocardial infarction or coronary artery surgery within 6months 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

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Ghost ileostomy
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2027

Study 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.