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RISE Ileocecal Valve Functional Reconstruction

ConditionRight-sided Colon Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorArmy Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RISE (Revolute Insert Side-End ileocecal valve reconstruction)

    Procedure/Surgery

    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.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: RISE anastomosisExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
1 week after surgery

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

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

Time frame
30 days after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Army Medical University, China

Lead sponsor

Source ClinicalTrials.gov

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