RISE Ileocecal Valve Functional Reconstruction

NCT07167420 | Not Yet Recruiting

• 1 other identifier: RISE anastomosis 002
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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

Keywords

right-sided colon cancer; laparoscopic surgery; ileocecal valve

Outcome Measures

Primary Outcomes (1)

• Time to first formed stool after surgery (Bristol stool score < 4).

  According to the Bristol stool scale, stools are categorized into seven types. Since stool form is related to the duration of colonic transit, the scale can be used to assess intestinal transit time and evaluate anastomotic function. A score \>5 is defined as diarrhea, with a score of 6 indicating mild diarrhea and a score of 7 indicating severe diarrhea.

  1 week after surgery

Secondary Outcomes (12)

• Operation time

  during the surgery

• anastomosis time

  during surgery

• intraoperative blood loss

  during surgery

• Complications within 30 days after surgery

  30 days after surgery

• anastomosis healing

  3 months, 6 months and 1 year after surgery

Study Arms (2)

RISE anastomosis

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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

Interventions

RISE (Revolute Insert Side-End ileocecal valve reconstruction) 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.

RISE anastomosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Army Medical University, China: lead

Study Officials

• Weidong Xiao, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Xiao, MD

CONTACT

86-13996390860; xiaoweidong@tmmu.edu.cn

Zihan Wang, Ph.D

CONTACT

86-13618347369; shakehanhanhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share