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NCT Number: NCT07167420

RISE Ileocecal Valve Functional Reconstruction

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.

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Key information

Conditions

Right-sided Colon Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

RISE (Revolute Insert Side-End ileocecal valve reconstruction)

Procedure

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 outcomes

  1. Time to first formed stool after surgery (Bristol stool score < 4).

    Time frame: 1 week after surgery

    According to the Bristol stool scale, stools are categorized into seven types. Since stool form is related to the duration of colonic transit, the scale can be used to assess intestinal transit time and evaluate anastomotic function. A score >5 is defined as diarrhea, with a score of 6 indicating mild diarrhea and a score of 7 indicating severe diarrhea.

Secondary outcomes

  1. Operation time

    Time frame: during the surgery

  2. anastomosis time

    Time frame: during surgery

  3. intraoperative blood loss

    Time frame: during surgery

  4. Complications within 30 days after surgery

    Time frame: 30 days after surgery

    Surgical complications evaluation was based on the Clavien-Dindo complication scoring system.

    Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

    Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management Grade V Death of a patient

  5. anastomosis healing

    Time frame: 3 months, 6 months and 1 year after surgery

    Colonoscopy is used to assess the healing status of an anastomosis, and to determine whether stenosis, ulcers, or other pathological changes have occurred.

  6. albumin level

    Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery.

    for assessing the nutritional status.

  7. bile acid

    Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery

    for assessing the nutritional status.

  8. VitB12

    Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery

    for assessing the nutritional status.

  9. total protein

    Time frame: 3 days, 1 month, 3 months, 6 months and 1 year after surgery

    for assessing the nutritional status

  10. EORTCQLQ-C30

    Time frame: baseline, 1 month after surgery.

    for assessing quality of life after surgery

  11. EORTCQLQ-CR2930

    Time frame: baseline, 1 month after surgery.

    for assessing quality of life after surgery

  12. gut microbiota

    Time frame: 1 month, 3 months, 6 months and 1 year after surgery.

    Analyzing the changes in gut microbiota through the patient's fecal samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Weidong Xiao, MD

CONTACT

[email protected]

86-13996390860

Zihan Wang, Ph.D

CONTACT

[email protected]

86-13618347369

Sponsors and collaborators

Lead sponsor

Army Medical University, China

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
Sep 11, 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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