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Completed

NCT Number: NCT05915052

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

B-type suture ileostomy

Procedure

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

Procedure

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.

Primary outcomes

  1. total operative time

    Time frame: one year

    the operating time of the two groups

  2. ileostomy time

    Time frame: one year

    time spent on ileostomies by the two groups

  3. bleeding volume

    Time frame: one year

    Intraoperative bleeding in both groups

  4. time of stoma evacuation

    Time frame: one year

    time of stoma evacuation for the two groups

  5. time of starting to eat

    Time frame: one year

    time of starting to eat in both groups

  6. time to first ambulation

    Time frame: one year

    time to first ambulation in both groups

  7. postoperative hospital stay

    Time frame: one year

    postoperative hospital stay in both groups

Secondary outcomes

  1. Complications related to the stoma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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