Clinical trial NCT05915052: B-suture Ileostomy in Clinical Practice: a Retrospective, Single-center, Propensity Score-matched Study
Official title: A New Type of Temporary Ileostomy --B-suture Ileostomy Applied to Laparoscopic Low Anterior Rectal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Ileostomies
Loop Ileostomies
Keywords: Loop Ileostomies
ileostomy
traditional
laparoscopic low anterior rectal resection
complications
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: To minimize bias in baseline characteristics between the B-suture stoma group and the conventional method stoma group, we performed propensity score matching (pSM) with a matching tolerance (M) set at 0.02 and nearest neighbor matching without put-back at a ratio of 1:1. Baseline information for matching was: gender, age, BMI, hemoglobin, albumin, diabetes, hypertension, previous abdominal surgery history, distance of the lower margin of the tumor from the anal margin, tumor diameter, American Society of Anesthesiology (ASA) physical classification, and tumor stage. 62 patients in the B-suture stoma group were successfully matched 1:1 with 123 patients in the conventional stoma group to 59 patients in the B-suture stoma group and 59 patients in the conventional stoma group. 59 patients in the B-stitch stoma group and 59 patients in the conventional stoma group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: total operative time
timeFrame: one year
measure: ileostomy time
timeFrame: one year
measure: bleeding volume
timeFrame: one year
measure: time of stoma evacuation
timeFrame: one year
measure: time of starting to eat
timeFrame: one year
measure: time to first ambulation
timeFrame: one year
measure: postoperative hospital stay
timeFrame: one year
Secondary outcomes:
measure: Complications related to the stoma
timeFrame: one year
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
affiliation: https://www.yzsbh.com/
name: sun longhe, Master
role: PRINCIPAL_INVESTIGATOR
References: