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

Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05915052
• Other study ID #: NorthernJiangsu002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 6, 2023

Study information

• Verified date: April 2024
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 6, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ileostomy

Intervention

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 .
• 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.

Locations

Country	Name	City	State
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total operative time	the operating time of the two groups	one year
Primary	ileostomy time	time spent on ileostomies by the two groups	one year
Primary	bleeding volume	Intraoperative bleeding in both groups	one year
Primary	time of stoma evacuation	time of stoma evacuation for the two groups	one year
Primary	time of starting to eat	time of starting to eat in both groups	one year
Primary	time to first ambulation	time to first ambulation in both groups	one year
Primary	postoperative hospital stay	postoperative hospital stay in both groups	one year
Secondary	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