RISE Ileocecal Valve Functional Reconstruction

NCT ID: NCT07167420

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-10-01

Brief Summary

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.

Conditions

Right-sided Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RISE anastomosis

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.

Group Type: EXPERIMENTAL

RISE (Revolute Insert Side-End ileocecal valve reconstruction)

Intervention Type: PROCEDURE

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RISE (Revolute Insert Side-End ileocecal valve reconstruction)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Army Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Weidong Xiao

Chief of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weidong Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery, Xinqiao Hospital, Army Medical University, No.183 Xinqiao Road, Chongqing, 400037, China

Central Contacts

Weidong Xiao, MD

Role: CONTACT

xiaoweidong@tmmu.edu.cn

86-13996390860

Zihan Wang, Ph.D

Role: CONTACT

shakehanhanhan@hotmail.com

86-13618347369

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RISE anastomosis 002

Identifier Type: -

Identifier Source: org_study_id