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

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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy; Ileostomies; Loop Ileostomies
• Intervention / Treatment: Procedure: B-type suture ileostomy; Procedure: the traditional ileostomy

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 Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the B-type suture ileostomy group; the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy	Procedure: B-type suture ileostomy; 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 .
Active Comparator: the traditional ileostomy group; the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy	Procedure: the traditional ileostomy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital
• Investigators: Principal Investigator: sun longhe, Master, https://www.yzsbh.com/

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ileostomy; complications; Loop Ileostomies; traditional; laparoscopic low anterior rectal resection
• Other Study ID Numbers: NorthernJiangsu002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No