Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604052
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
A Study Comparing LaparoscopicRobotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Parallel-Controlled Study Comparing LaparoscopicRobotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUSION
Brief Summary:
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 trocarstoma fusion positioning and intraoperative trocarstoma fusion surgery The procedure is based on the 3R principles Reposition - the stoma is repositioned within the Joint TrocarStoma 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 11 ratio The experimental group will undergo Reduced-Port Fusion Surgery while the control group will receive traditional surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None