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

Not Applicable

Completed

• Conditions: Ileostomy; Ileostomies; Loop Ileostomies
• Interventions: Procedure: the traditional ileostomy; Procedure: B-type suture ileostomy

• Registration Number: NCT05915052
• Lead Sponsor: Northern Jiangsu People's Hospital

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-12-31
• Study First Submitted: 2023-06-05
• Study Completion: 2023-06-06
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
the traditional ileostomy group	the traditional ileostomy	the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy
the B-type suture ileostomy group	B-type suture ileostomy	the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complications related to the stoma	one year	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

Trial Locations

Locations (1)

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China