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Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy

A Retrospective Cohort Study Evaluating the Safety and Clinical Efficacy of a Novel Anastomotic Technique for Restoring Ileocecal Valve Function During Laparoscopic Radical Resection of Right-Sided Colon Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07095985
Enrollment
43
Registered
2025-07-31
Start date
2024-07-01
Completion date
2024-12-30
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radical Right Hemicolectomy

Keywords

Right hemicolectomy, Ileocecal valve reconstruction, RISE anastomosis, Laparoscopic surgery, Colon cancer, Anastomotic technique, Bowel function, Retrospective cohort study

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.

Interventions

None listed

Sponsors

Army Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo).from day1 to day30 after surgeryAfter 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

MeasureTime frameDescription
Time to first flatusfrom day1 to day7 after surgeryRecord the time of the patient's first bowel movement after surgery.
Time to first formed stoolfrom day1 to day30 after surgeryRecord the time of the patient's first formed stool after surgery.

Other

MeasureTime frameDescription
Operative timeDuring the operationSurgical time, as recorded on the anesthesia record.
Inflammatory markersfrom day1 to day7 after surgeryThe value of white blood cell count in the complete blood count (CBC) test.
Anastomosis timeDuring the operationAnastomosis time: Calculated based on the surgical video recordings.
Blood lossDuring the operationblood loss, as recorded on the anesthesia record.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026