Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06604052

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

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-09-19

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new surgical method called Reduced-Port Fusion Surgery for patients undergoing temporary ileostomy during laparoscopic or robotic colorectal surgery. This study compares this new technique with traditional stoma positioning and surgery methods to see if it can reduce complications, lessen postoperative pain, improve quality of life, and make stoma retraction surgery easier. A total of 80 patients will be randomly assigned to either the new or traditional surgery group. The Reduced-Port Fusion Surgery involves preoperative planning where the stoma therapist and surgeon collaborate to create a joint trocar and stoma fusion point that allows more lateral stoma placement outside the rectus abdominis muscle. During surgery, the main trocar incision is extended to create the ileostomy at this fusion site, allowing dual use of one incision. The control group will receive traditional stoma positioning within the rectus abdominis and conventional ileostomy creation, ensuring the trocar and stoma sites do not overlap. Participants will be monitored for stoma-related complications, skin infection rates, hernia incidence, postoperative pain, and quality of life at 7, 30, and 90 days after surgery. Evaluations include the DET score assessing skin discoloration, erosion, and tissue overgrowth. The study also tracks infection rates at the stoma and trocar sites, parastomal hernia development, and pain levels. Quality of life is assessed at 30 and 90 days. The trial aims to provide detailed safety and effectiveness data over this follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for laparoscopic or robotic colorectal surgery (rectum, sigmoid colon, left colon) planned to have prophylactic ileostomy
  • No serious systemic infection or immunosuppression
  • Age 18 years or older
  • Eastern Cooperative Oncology Group Performance Status of 0-1
  • Expected survival time greater than 6 months
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Any skin infectious diseases on the abdominal wall
  • Use of hormones or immunosuppressive drugs within 1 month before surgery
  • Time between operation and last chemotherapy less than 1 month
  • Any previous ostomy surgery
  • Any serious active or uncontrollable infection requiring systemic treatment
  • History of neurological or psychiatric disorders
  • Inability to complete the study for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo either laparoscopic/robotic reduced-port fusion surgery or traditional stoma surgery with preoperative stoma positioning.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 90 days after surgery

Participants are monitored for complications, skin infections, pain, and quality of life after surgery.

Visits at 7, 30, and 90 days after surgery

Trial Site Locations

Total: 1 location

1

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China, 200092

Actively Recruiting

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Research Team

T

Tingyu Wu, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Frequently Asked Questions

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