RISE Ileocecal Valve Functional Reconstruction

Army Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Right-sided Colon Cancer

Treatments: Procedure: RISE (Revolute Insert Side-End ileocecal valve reconstruction)

Study type: Interventional

Funder types: Other

Identifiers

NCT07167420

RISE anastomosis 002

Details and patient eligibility

About

The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged 18-80 years;
• ASA score ≤ 3;
• Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure of the colon, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic radical right hemicolectomy;
• No history of other gastrointestinal diseases (except for intestinal polyps or gallstones);
• Willing to participate in the study and sign the informed consent form;
• Complete clinical data available.

Exclusion criteria

• Presence of other malignant tumors in different organs;
• Tumor invasion into adjacent organs;
• Patients with concurrent infectious diseases or autoimmune diseases (e.g., Crohn's disease);
• Patients with congenital or acquired metabolic disorders;
• Use of antibiotics or other microbiota-altering medications within one month prior to enrollment;
• Changes in surgical plan resulting in the resection not including the ileocecal valve.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

RISE anastomosis

Experimental group

Description:

After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.

Treatment:

Procedure: RISE (Revolute Insert Side-End ileocecal valve reconstruction)

Control

No Intervention group

Description:

Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection.