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

NCT05915052 | Completed

• 1 other identifier: NorthernJiangsu002
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ileostomy; Ileostomies; Loop Ileostomies

Keywords

Loop Ileostomies; ileostomy; traditional; laparoscopic low anterior rectal resection; complications

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Complications related to the stoma

  one year

Study Arms (2)

the B-type suture ileostomy group

ACTIVE COMPARATOR

the B-type suture ileostomy group underwent laparoscopic low anterior resection and a B-type suture ileostomy

Procedure: B-type suture ileostomy

the traditional ileostomy group

ACTIVE COMPARATOR

the traditional ileostomy group underwent laparoscopic low anterior resection and a traditional ileostomy

Procedure: the traditional ileostomy

Interventions

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 B-type suture ileostomy group

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.

the traditional ileostomy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Related Publications (1)

• Sun L, Zhou J, Ji L, Wang W, Zhang Q, Qian C, Zhao S, Li R, Wang D. Clinical application of the B-type sutured ileostomy in robotic-assisted low anterior resection for rectal cancer: a propensity score matching analysis. J Robot Surg. 2024 Apr 5;18(1):159. doi: 10.1007/s11701-024-01924-8.

  PMID: 38578352 DERIVED

Study Officials

• sun longhe, Master

  https://www.yzsbh.com/

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: To minimize bias in baseline characteristics between the B-suture stoma group and the conventional method stoma group, we performed propensity score matching (pSM) with a matching tolerance (M) set at 0.02 and nearest neighbor matching without put-back at a ratio of 1:1. Baseline information for matching was: gender, age, BMI, hemoglobin, albumin, diabetes, hypertension, previous abdominal surgery history, distance of the lower margin of the tumor from the anal margin, tumor diameter, American Society of Anesthesiology (ASA) physical classification, and tumor stage. 62 patients in the B-suture stoma group were successfully matched 1:1 with 123 patients in the conventional stoma group to 59 patients in the B-suture stoma group and 59 patients in the conventional stoma group. 59 patients in the B-stitch stoma group and 59 patients in the conventional stoma group.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: June 6, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)