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Not yet recruiting NCT07167420

RISE Ileocecal Valve Functional Reconstruction

No phase Interventional Right-sided Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RISE (Revolute Insert Side-End ileocecal valve reconstruction).
Who it may be relevant to
Registry conditions: Right-sided Colon Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

RISE Ileocecal Valve Functional Reconstruction for the Prevention of Postoperative Intestinal Dysfunction After Robotic/Laparoscopic Right Hemicolectomy: a Single-blind, Two-arm, Multicenter Randomized Controlled Clinical Study

Overview

The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.

Interventions

  • Procedure RISE (Revolute Insert Side-End ileocecal valve reconstruction)
    After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.

Primary outcome measures

  • Time to first formed stool after surgery (Bristol stool score < 4). [Time frame: 1 week after surgery]
Secondary outcome measures (12)
  • Operation time [Time frame: during the surgery]
  • anastomosis time [Time frame: during surgery]
  • intraoperative blood loss [Time frame: during surgery]
  • Complications within 30 days after surgery [Time frame: 30 days after surgery]
  • anastomosis healing [Time frame: 3 months, 6 months and 1 year after surgery]
  • albumin level [Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery.]
  • bile acid [Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
  • VitB12 [Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
  • total protein [Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
  • EORTCQLQ-C30 [Time frame: baseline, 1 month after surgery.]
  • EORTCQLQ-CR2930 [Time frame: baseline, 1 month after surgery.]
  • gut microbiota [Time frame: 1 month, 3 months, 6 months and 1 year after surgery.]

Eligibility criteria

Inclusion criteria

  • Subjects aged 18-80 years;
  • ASA score ≤ 3;
  • Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure of the colon, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic radical right hemicolectomy;
  • No history of other gastrointestinal diseases (except for intestinal polyps or gallstones);
  • Willing to participate in the study and sign the informed consent form;
  • Complete clinical data available.

Exclusion criteria

  • Presence of other malignant tumors in different organs;
  • Tumor invasion into adjacent organs;
  • Patients with concurrent infectious diseases or autoimmune diseases (e.g., Crohn's disease);
  • Patients with congenital or acquired metabolic disorders;
  • Use of antibiotics or other microbiota-altering medications within one month prior to enrollment;
  • Changes in surgical plan resulting in the resection not including the ileocecal valve.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07167420 · RISE anastomosis 002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗