Clinical trial NCT06604052: A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Official title: A Prospective, Randomized, Parallel-Controlled Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ileostomy
Keywords: ileostomy
minimally invasive surgery
Reduced-Port Fusion Surgery
stoma complication
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: Inclusion Criteria:

1. After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to undergo prophylactic ileostomy.
2. No serious systemic infection or immunosuppression.
3. Over 18 years of age.
4. Eastern Cooperative Oncology Group Performance Status: 0-1
5. The expected survival time \> 6 months.
6. The subjects voluntarily participate and sign the informed consent

Exclusion Criteria:

1. Any skin infectious diseases in the abdominal wall.
2. Use hormones and immunosuppressive drugs within 1 month before surgery.
3. The time between operation and the last chemotherapy was less than 1 month.
4. Any previous ostomy surgery.
5. Any serious active infection or uncontrollable infection that requires systematic treatment.
6. A clear history of neurological or psychiatric disorders.
7. Subjects may not be able to complete the study for other reasons.

Primary outcomes:
measure: Overall complication rate of stoma
timeFrame: 7, 30, and 90 days after surgery
Secondary outcomes:
measure: DET（Discoloration，Erosion and Tissue overgrowth） score
timeFrame: 7, 30, and 90 days after surgery
measure: Stomal skin infection rate
timeFrame: 7, 30, and 90 days after surgery
measure: Parastostomy trocar incision infection rate
timeFrame: 7, 30, and 90 days after surgery
measure: Parastomal hernia rate
timeFrame: 7, 30, and 90 days after surgery
measure: Stoma Pain Score
timeFrame: 7, 30, and 90 days after surgery
measure: Quality of life scale score
timeFrame: 30 and 90 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References: