Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy

Completed

• Conditions: Radical Right Hemicolectomy

• Registration Number: NCT07095985
• Lead Sponsor: Army Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30
• Study First Submitted: 2025-06-26
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo).	from day1 to day30 after surgery	After the surgery, continuously record whether the patient has any adverse reactions until 30 days postoperatively, and score the severity of the adverse reactions according to the Clavien-Dindo classification.

Secondary Outcome Measures

Name	Time	Method
Time to first flatus	from day1 to day7 after surgery	Record the time of the patient's first bowel movement after surgery.
Time to first formed stool	from day1 to day30 after surgery	Record the time of the patient's first formed stool after surgery.

Trial Locations

Locations (1)

Xinqiao Hospital; 🇨🇳 Chongqing, Chongqing, China