B-suture Ileostomy in Clinical Practice: a Retrospective, Single-center, Propensity Score-matched Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A New Type of Temporary Ileostomy --B-suture Ileostomy Applied to Laparoscopic Low Anterior Rectal Resection

Conditions
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Ileostomy, Ileostomies, Loop Ileostomies

Intervention / Treatment
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* Procedure: B-type suture ileostomy
* Procedure: the traditional ileostomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the B-type suture ileostomy group<br>the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy | Procedure: B-type suture ileostomy<br>* Type B suture stoma group：2-0 stitched sutures were placed in the center of the incision, from the anterior rectus sheath on the left side of the incision → the posterior rectus sheath on the left side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the right side of the incision → the anterior rectus sheath on the right side of the incision→ the posterior rectus sheath on the right side of the incision → through the avascular area below the vascular arch at the mesenteric border of the ileum to the contralateral side → the posterior rectus sheath on the left side of the incision →the anterior rectus sheath on the left side of the incision sutures were sewn through in the sequence, tightened and knotted .<br>|
| Active Comparator: the traditional ileostomy group<br>the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy | Procedure: the traditional ileostomy<br>* Then take the right lower abdominal incision to cut a circular incision of 3 cm in diameter, round excision of subcutaneous fat, cross incision of rectus sheath and peritoneum, enter the abdomen, raise the marked ileum out of the body, interrupt suture of ileum with peritoneum and posterior sheath of rectus abdominis for one week, then interrupt suture of ileum with anterior sheath of rectus abdominis for one week, transverse incision of 2 cm in diameter, interrupted with 3-0 absorbable thread, The ileocecal incision and the skin of the right lower abdominal circular incision were sutured for one week to complete the double-lumen stoma at the end of the ileum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operative time | the operating time of the two groups | one year | 
| ileostomy time | time spent on ileostomies by the two groups | one year | 
| bleeding volume | Intraoperative bleeding in both groups | one year | 
| time of stoma evacuation | time of stoma evacuation for the two groups | one year | 
| time of starting to eat | time of starting to eat in both groups | one year | 
| time to first ambulation | time to first ambulation in both groups | one year | 
| postoperative hospital stay | postoperative hospital stay in both groups | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to the stoma | Complications related to the stoma in both groups，such as irritant dermatitis、Parastomal hernia、Incisional hernia、Intestinal obstruction、Stoma bleeding Peristomal infection、Infection of specimen 、removal incision、Stoma stenosis、Stoma retraction、Stoma prolapse、Dehydration | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loop Ileostomies, ileostomy, traditional, laparoscopic low anterior rectal resection, complications