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

NCT06604052 | Recruiting

• 1 other identifier: XHEC-C-2024-158-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy

Keywords

ileostomy; minimally invasive surgery; Reduced-Port Fusion Surgery; stoma complication

Outcome Measures

Primary Outcomes (1)

• Overall complication rate of stoma

  Observe and assess for stoma complications

  7, 30, and 90 days after surgery

Secondary Outcomes (6)

• DET（Discoloration，Erosion and Tissue overgrowth） score

  7, 30, and 90 days after surgery

• Stomal skin infection rate

  7, 30, and 90 days after surgery

• Parastostomy trocar incision infection rate

  7, 30, and 90 days after surgery

• Parastomal hernia rate

  7, 30, and 90 days after surgery

• Stoma Pain Score

  7, 30, and 90 days after surgery

Study Arms (2)

Reduced-Port Fusion Surgery Group

EXPERIMENTAL

Recive preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery

Procedure: Reduced-Port Fusion Surgery

Traditional surgery group

ACTIVE COMPARATOR

Recive traditional preoperative stoma positioning and traditional stoma surgery

Procedure: Traditional surgery

Interventions

Reduced-Port Fusion Surgery PROCEDURE

(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.

Reduced-Port Fusion Surgery Group

Traditional surgery PROCEDURE

(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.

Traditional surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092, China

RECRUITING

Central Study Contacts

Tingyu Wu, PhD

CONTACT

China: +86-021-25077855; wutingyu@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)