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

N

Northern Jiangsu People's Hospital

Status

Completed

Conditions

Loop Ileostomies
Ileostomies
Ileostomy

Treatments

Procedure: the traditional ileostomy
Procedure: B-type suture ileostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05915052
NorthernJiangsu002

Details and patient eligibility

About

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.

Full 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.

Enrollment

185 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

185 participants in 2 patient groups

the B-type suture ileostomy group
Active Comparator group
Description:
the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy
Treatment:
Procedure: B-type suture ileostomy
the traditional ileostomy group
Active Comparator group
Description:
the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy
Treatment:
Procedure: the traditional ileostomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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