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Completed

NCT Number: NCT07095985

Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo).

    Time frame: 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 outcomes

  1. Time to first flatus

    Time frame: from day1 to day7 after surgery

    Record the time of the patient's first bowel movement after surgery.

  2. Time to first formed stool

    Time frame: from day1 to day30 after surgery

    Record the time of the patient's first formed stool after surgery.

Other outcomes

  1. Operative time

    Time frame: During the operation

    Surgical time, as recorded on the anesthesia record.

  2. Anastomosis time

    Time frame: During the operation

    Anastomosis time: Calculated based on the surgical video recordings.

  3. Blood loss

    Time frame: During the operation

    blood loss, as recorded on the anesthesia record.

  4. Inflammatory markers

    Time frame: from day1 to day7 after surgery

    The value of white blood cell count in the complete blood count (CBC) test.

Sponsors and collaborators

Lead sponsor

Army Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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