Actively Recruiting
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-09-19
80
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 incision being too close to the stoma site, increasing the risk of baseplate leakage and skin infection. (2) Since stoma positioning is required to be within the rectus abdominis, the proximity between the stoma and auxiliary incision can heighten difficulties in stoma bag attachment and raises the risk of fecal leakage. (3) Stoma retraction surgery within the rectus abdominis is more traumatic and complex. We introduce for the first time a modified stoma positioning and surgical method, termed Reduced-Port Fusion Surgery. This technique includes preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery. The procedure is based on the 3R principles: Reposition - the stoma is repositioned within the Joint Trocar/Stoma Zone, allowing for more lateral placement to meet surgical needs without being confined to the rectus abdominis. Reduce Port - the same fusion point is used for both trocar insertion and stoma creation, enabling dual use of one site. Recognize - surgeons participate in stoma positioning, recognize the positioning, and follow the procedure. This prospective, randomized, parallel-controlled clinical study aims to evaluate whether Reduced-Port Fusion Surgery can reduce stoma-related complications, postoperative pain, improve quality of life, and facilitate stoma retraction surgery compared to traditional methods. A total of 80 participants will be randomly assigned in a 1:1 ratio. The experimental group will undergo Reduced-Port Fusion Surgery while the control group will receive traditional surgery.
CONDITIONS
Official Title
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) with planned prophylactic ileostomy
- No serious systemic infection or immunosuppression
- Age over 18 years
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Expected survival time longer than 6 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Presence of any skin infectious diseases in the abdominal wall
- Use of hormones or immunosuppressive drugs within 1 month before surgery
- Time between operation and last chemotherapy less than 1 month
- Previous ostomy surgery
- Serious active or uncontrollable infection requiring systemic treatment
- History of neurological or psychiatric disorders
- Inability to complete the study for any other reason
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, China, 200092
Actively Recruiting
Research Team
T
Tingyu Wu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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