Status:
RECRUITING
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar inc...
Eligibility Criteria
Inclusion
- After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to undergo prophylactic ileostomy.
- No serious systemic infection or immunosuppression.
- Over 18 years of age.
- Eastern Cooperative Oncology Group Performance Status: 0-1
- The expected survival time \> 6 months.
- The subjects voluntarily participate and sign the informed consent
Exclusion
- Any skin infectious diseases in the abdominal wall.
- Use hormones and immunosuppressive drugs within 1 month before surgery.
- The time between operation and the last chemotherapy was less than 1 month.
- Any previous ostomy surgery.
- Any serious active infection or uncontrollable infection that requires systematic treatment.
- A clear history of neurological or psychiatric disorders.
- Subjects may not be able to complete the study for other reasons.
Key Trial Info
Start Date :
September 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06604052
Start Date
September 6 2024
End Date
December 31 2025
Last Update
September 19 2024
Active Locations (1)
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1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, China, 200092