Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy

NCT ID: NCT07095985

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-12-30

Brief Summary

This is a single-center retrospective cohort study conducted by the Department of General Surgery at the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital). The study aims to evaluate the safety and clinical efficacy of a novel anastomotic technique designed to reconstruct ileocecal valve (ICV) function during laparoscopic right hemicolectomy for right-sided colon cancer.

Background: Standard right hemicolectomy necessitates resection of the ICV, a critical structure regulating ileocolonic transit and acting as a bacterial barrier. Its loss can lead to small intestinal bacterial overgrowth (SIBO), diarrhea, malabsorption, and reduced quality of life. While preserving the ICV is ideal when oncologically feasible, it's often unavoidable. This study proposes an innovative anastomosis technique ("Revolute Insert Side-End Ileocecal Valve Reconstruction" - "RISE anastomosis") to functionally reconstruct the ICV.

Study Design:

Population: 50 patients who underwent laparoscopic right hemicolectomy at the center, meeting inclusion/exclusion criteria (age 18-80, ASA ≤3, primary tumors in appendix, cecum, ascending colon, hepatic flexure, or proximal 1/3 transverse colon, complete data).

Groups:

Conventional Anastomosis Group (n=30): Standard side-to-side ileocolic anastomosis using a linear stapler.

RISE anastomosis Group (n=20): Novel technique involving everting the ileal stump with sutures to create an artificial valve, then implanting it into an incision on the colonic wall and suturing it circumferentially.

Primary Objective: Assess safety and feasibility of RISE anastomosis.

Secondary Objective: Evaluate the clinical efficacy of RISE anastomosis on bowel function recovery.

Key Outcomes:

Safety (Primary): 30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo).

Efficacy (Secondary): Time to first flatus, first defecation, first formed stool; Bristol stool scale; defecation frequency/urgency; incontinence rates; length of stay; reoperation/readmission rates.

Other: Operative time, anastomosis time, blood loss, lymph node yield, inflammatory markers, follow-up assessments (contrast studies, endoscopy).

Data Analysis: Data extracted from electronic medical records. Statistical analysis using SPSS 22.0 (χ² test for categorical data, t-test for normally distributed continuous data; significance p<0.05).

Ethics: Approved by the institutional ethics committee. Conducted in accordance with the Declaration of Helsinki and Chinese regulations. Patient privacy and data confidentiality are prioritized.

Timeline: Patient data collection and analysis (Jun-Aug 2024); Statistical analysis and manuscript preparation (Sep-Dec 2024).

Significance: This study investigates a potentially transformative surgical technique. If proven safe and effective, RISE anastomosis could significantly improve postoperative bowel function and quality of life for patients requiring ICV resection during right hemicolectomy, addressing a major unmet clinical need related to ICV loss.

Conditions

Radical Right Hemicolectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

RISE anastomosis

Following right hemicolectomy, the novel RISE-ICVR technique involves everting the ileal stump to create an artificial valve, implanting it into a colonic wall incision, and securing it with circumferential sutures.

No interventions assigned to this group

Conventional Anastomosis Group

In contrast, the conventional approach uses a linear stapler to perform a side-to-side ileocolic anastomosis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status classification of II-III.
• Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic right hemicolectomy.
• No history of other gastrointestinal diseases (excluding intestinal polyps and gallstones).
• Willingness to participate in the study with signed informed consent.
• Complete clinical data available.

Exclusion Criteria

• Presence of malignancies in other anatomical sites.
• Tumor invasion into adjacent organs.
• Presence of infectious or autoimmune diseases (e.g., Crohn's disease).
• Congenital or acquired metabolic disorders.
• Use of antibiotics or other microbiota-altering medications within one month before enrollment.
• Changes in surgical plan such that the resection does not include 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

Head of General Surgery, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weidong Xiao, MD

Role: STUDY_CHAIR

Second Affiliated Hospital of Army Medical University

Locations

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

RISE anastomosis 001

Identifier Type: -

Identifier Source: org_study_id