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

A Prospective, Randomized, Parallel-Controlled Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy

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.

Study Overview

• Status: Recruiting
• Conditions: Ileostomy
• Intervention / Treatment: Procedure: Reduced-Port Fusion Surgery; Procedure: Traditional surgery

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tingyu Wu, PhD; Phone Number: China: +86-021-25077855; Email: wutingyu@xinhuamed.com.cn

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Min Shi; Phone Number: China:+86-021-25076143; Email: xinhuahospitalec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced-Port Fusion Surgery Group; Recive preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery	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.
Active Comparator: Traditional surgery group; Recive traditional preoperative stoma positioning and traditional stoma surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall complication rate of stoma	Observe and assess for stoma complications	7, 30, and 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DET（Discoloration，Erosion and Tissue overgrowth） score	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	7, 30, and 90 days after surgery
Stomal skin infection rate	Observe and assess for stomal skin infection rate	7, 30, and 90 days after surgery
Parastostomy trocar incision infection rate	To observe whether trocar incision infection occurred	7, 30, and 90 days after surgery
Parastomal hernia rate	To observe whether parastomal hernia occurred	7, 30, and 90 days after surgery
Stoma Pain Score	Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain	7, 30, and 90 days after surgery
Quality of life scale score	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	30 and 90 days after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ileostomy; minimally invasive surgery; Reduced-Port Fusion Surgery; stoma complication
• Other Study ID Numbers: XHEC-C-2024-158-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In this study personal information and data such as patient history, physical examination results, surgical records, and study questionnaire data will be collected. These data will be used to evaluate the efficacy and safety of the new procedure and for academic publication. The researcher will treat the patients' personal data confidentially and anonymize the data and information in any public release of the results of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No