Comparing a new surgical method for temporary ileostomy with traditional surgery

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

This study is testing a new, less invasive surgery for temporary ileostomy to see if it leads to fewer complications and better recovery compared to traditional surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, China)
• Trial ID: NCT06604052 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel surgical technique called Reduced-Port Fusion Surgery for patients undergoing temporary ileostomy, comparing it to traditional surgical methods. The new approach aims to minimize complications associated with stoma positioning and improve patient outcomes by repositioning the stoma within a designated zone. The study focuses on patients scheduled for laparoscopic or robotic colorectal surgery and assesses the effectiveness and safety of this minimally invasive technique. Participants will be monitored for complications and overall recovery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 scheduled for laparoscopic or robotic colorectal surgery requiring a prophylactic ileostomy.

Not a fit: Patients with a history of ostomy surgery or serious infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce complications and improve recovery for patients with temporary ileostomy.

How similar studies have performed: While this specific approach is novel, similar minimally invasive techniques have shown promise in other surgical contexts.

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.

Where this trial is running

Shanghai, China

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China, China (RECRUITING)

Study contacts

• Study coordinator: Tingyu Wu, PhD

Conditions: Ileostomy, ileostomy, minimally invasive surgery, Reduced-Port Fusion Surgery, stoma complication