Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Location status: Recruiting
NCT Number: NCT06604052
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shanghai, China, 200092
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(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.
(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.
Time frame: 7, 30, and 90 days after surgery
Observe and assess for stoma complications
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
Time frame: 7, 30, and 90 days after surgery
Observe and assess for stomal skin infection rate
Time frame: 7, 30, and 90 days after surgery
To observe whether trocar incision infection occurred
Time frame: 7, 30, and 90 days after surgery
To observe whether parastomal hernia occurred
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
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
Contact information is provided by the study sponsor or research team.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Other
A Prospective, Randomized, Parallel-Controlled Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Acronym: FUSION
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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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