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

NCT06604052 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Ileostomy

Interventions

PROCEDURE

Reduced-Port Fusion Surgery

(1) The Joint Trocar/Stoma Zone will be delineated by the stoma therapist. (2) The placement of the fusion point will involve collaboration between the surgeon and stoma therapist. This will be based on the surgeon\'s trocar placement plan and the stoma therapist\'s positioning principles. (3) Follow the principles of modified stomal positioning. (4) The surgeon will insert the main trocar based on the preoperative positioning point. During stoma creation, the 12 mm main trocar incision will be extended to 25-30 mm to create an ileostomy.

PROCEDURE

Traditional surgery

(1) The stoma therapists perform stoma positioning using traditional stoma positioning method. The surgeon will determine the primary trocar location, ensuring it does not overlap with the stoma site. (2) The surgeon will insert the primary trocar based on the preoperative positioning point and conduct the surgery. During stoma creation, the surgeons create ileal stoma according to the preoperative stoma positioning point.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604052 on ClinicalTrials.gov