A New Type of Temporary Ileostomy --B-suture Ileostomy Applied to Laparoscopic Low Anterior Rectal Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- ileostomy time
Study Overview
Brief Summary
OBJECTIVE: The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.
CONCLUSION: This study shows that B-suture ileostomy can simplify the surgical procedure, facilitate learning and promotion, shorten the stoma and surgical time, can reduce complications such as irritant dermatitis, peristoma infection, stoma stricture, stoma retraction, shorten the hospital stay, reduce postoperative pain, and is similar to the traditional procedure in terms of secondary surgical return, which is a surgical procedure worth continuing to explore.
Detailed Description
OBJECTIVE
The purpose of this study was to introduce a new temporary ileostomy modality, the B-suture ileostomy, and to compare its technical advantages in comparison with conventional ileostomy.
METHODS: A retrospective single-center study analyzed 185 patients undergoing laparoscopic low anterior resection for rectal cancer combined with temporary ileostomy, collecting general case data, surgery-related data, postoperative-related complications, secondary surgical return data, and postoperative health status data, and divided into a B-suture ileostomy group (n=62) and a conventional method ileostomy group (n=123) according to the different stoma methods, by propensity score matching (pSM) for 1:1 matching (n=59 for both groups after matching). The advantages and disadvantages of the B-suture method ileostomy were evaluated by analyzing and comparing information on the perioperative period, postoperative related complications, and postoperative health status.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list. For example:simultaneous laparoscopic low anterior resection of rectal cancer + temporary ileostomy;
- •pathologically confirmed primary rectal cancer;
- •rectal tumor height ≤12 cm from the anal verge;
- •no tumor metastasis at the time of surgical resection;
- •all surgeries were performed by the same surgical team with more than 10 years of experience in laparoscopic radical resection of rectal cancer and ileostomy.
Exclusion Criteria
- •patients who did not undergo stoma rejection due to tumor metastasis or recurrence;
- •patients who were too old or in poor general condition to undergo stoma reversal surgery;
- •patients with multiple primary colorectal cancers who underwent simultaneous multifocal resection;
- •patients with incomplete clinical medical information.
Outcomes
Primary Outcomes
ileostomy time
Time Frame: one year
time spent on ileostomies by the two groups
time of starting to eat
Time Frame: one year
time of starting to eat in both groups
time to first ambulation
Time Frame: one year
time to first ambulation in both groups
time of stoma evacuation
Time Frame: one year
time of stoma evacuation for the two groups
postoperative hospital stay
Time Frame: one year
postoperative hospital stay in both groups
total operative time
Time Frame: one year
the operating time of the two groups
bleeding volume
Time Frame: one year
Intraoperative bleeding in both groups
Secondary Outcomes
- Complications related to the stoma(one year)
Investigators
Daorong Wang
DR
Northern Jiangsu People's Hospital