Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

Shandong University

Status: Enrolling

Conditions: Ileostomy - Stoma; Rectal Neoplasms

Treatments: Procedure: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing; Procedure: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT06344923

KYLL

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preventive ileostomy in laparoscopic rectal surgery

Exclusion criteria

• ileostomy due to anastomotic leak

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

modified preventive ileostomy

Experimental group

Description:

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

Treatment:

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

conventional preventive ileostomy

Active Comparator group

Description:

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

Treatment:

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