No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer
Launched by FAN LI · Jan 17, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the differences between two surgical approaches for patients with rectal cancer who are undergoing a procedure called total mesorectal excision. Specifically, the study is comparing outcomes for patients who have a temporary stoma (a small opening in the abdomen to help with waste elimination) versus those who have no stoma at all. Researchers want to find out which method results in fewer complications, shorter hospital stays, and lower medical costs after surgery.
To be eligible for this trial, participants must be between 18 and 80 years old and have a confirmed diagnosis of rectal cancer. They should also either have a temporary stoma or no stoma created during their surgery. Certain health conditions, such as severe heart issues or kidney failure, might exclude someone from participating. If you join this study, you can expect to be monitored closely after your surgery for complications and will help researchers understand which approach is more beneficial for patients like you.
Gender
ALL
Eligibility criteria
- 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.
About Fan Li
Fan Li is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial design and execution. With a focus on developing novel therapeutic solutions, Fan Li collaborates with leading researchers and healthcare professionals to ensure rigorous study protocols and adherence to regulatory standards. Leveraging a wealth of expertise in various therapeutic areas, the organization emphasizes transparency, ethical practices, and patient-centric approaches, ultimately striving to contribute to the evolution of healthcare and the discovery of impactful treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported