A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy

Not Applicable

Recruiting

• Conditions: Ileostomy
• Interventions: Procedure: Reduced-Port Fusion Surgery; Procedure: Traditional surgery

• Registration Number: NCT06604052
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-06
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced-Port Fusion Surgery Group	Reduced-Port Fusion Surgery	Recive preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery
Traditional surgery group	Traditional surgery	Recive traditional preoperative stoma positioning and traditional stoma surgery

Primary Outcome Measures

Name	Time	Method
Overall complication rate of stoma	7, 30, and 90 days after surgery	Observe and assess for stoma complications

Secondary Outcome Measures

Name	Time	Method
DET（Discoloration，Erosion and Tissue overgrowth） score	7, 30, and 90 days after surgery	Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma
Stomal skin infection rate	7, 30, and 90 days after surgery	Observe and assess for stomal skin infection rate
Parastostomy trocar incision infection rate	7, 30, and 90 days after surgery	To observe whether trocar incision infection occurred
Parastomal hernia rate	7, 30, and 90 days after surgery	To observe whether parastomal hernia occurred
Stoma Pain Score	7, 30, and 90 days after surgery	Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain
Quality of life scale score	30 and 90 days after surgery	Measurement of quality of life for patients using the European Organization for Reasearch and Treatment of Cancer QLQ-C30 Questionnaire (EORTC QLQ-C30), ranging from 0-100, higher scores mean a better outcome of quality of life

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China