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NCT Number: NCT06604052

A 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200092

Location status: Recruiting

Location contact

Min Shi

CONTACT

[email protected]

China:+86-021-25076143

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Overall complication rate of stoma

    Time frame: 7, 30, and 90 days after surgery

    Observe and assess for stoma complications

Secondary outcomes

  1. DET(Discoloration,Erosion and Tissue overgrowth) score

    Time frame: 7, 30, and 90 days after surgery

    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

  2. Stomal skin infection rate

    Time frame: 7, 30, and 90 days after surgery

    Observe and assess for stomal skin infection rate

  3. Parastostomy trocar incision infection rate

    Time frame: 7, 30, and 90 days after surgery

    To observe whether trocar incision infection occurred

  4. Parastomal hernia rate

    Time frame: 7, 30, and 90 days after surgery

    To observe whether parastomal hernia occurred

  5. Stoma Pain Score

    Time frame: 7, 30, and 90 days after surgery

    Measurement of stoma pain level using numerical rating scale,ranging from 0-10, higher scores mean a worse outcome of pain

  6. Quality of life scale score

    Time frame: 30 and 90 days after surgery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Tingyu Wu, PhD

CONTACT

[email protected]

China: +86-021-25077855

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: FUSION

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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