Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

NCT ID: NCT06344923

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2025-09-01

Brief Summary

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In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.

Detailed Description

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Conditions

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Ileostomy - Stoma Rectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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modified preventive ileostomy

Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing

Group Type EXPERIMENTAL

Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing

Intervention Type PROCEDURE

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches.

conventional preventive ileostomy

Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Group Type ACTIVE_COMPARATOR

Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Intervention Type PROCEDURE

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches

Interventions

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Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches.

Intervention Type PROCEDURE

Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* preventive ileostomy in laparoscopic rectal surgery

Exclusion Criteria

* ileostomy due to anastomotic leak
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiang Zhang

Role: primary

+8618560089182

Other Identifiers

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KYLL

Identifier Type: -

Identifier Source: org_study_id

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