CompletedNot Applicable

Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy

China43 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: from day1 to day30 after surgery

Trial details

NCT IDNCT07095985

SponsorArmy Medical University, China

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Radical Right Hemicolectomy trials