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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05915052
Other study ID # NorthernJiangsu002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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