Right-sided Colon CancerNCT07167420
RISE Ileocecal Valve Functional Reconstruction
A study testing RISE (Revolute Insert Side-End ileocecal valve reconstruction) in people with Right-sided Colon Cancer, run by Army Medical University, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Right-sided Colon Cancer
- What is being tested?
- RISE (Revolute Insert Side-End ileocecal valve reconstruction)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Right-sided Colon Cancer
- Being tested
- RISE (Revolute Insert Side-End ileocecal valve reconstruction)
- Keywords
- right-sided colon cancer, laparoscopic surgery, ileocecal valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE (Revolute Insert Side-End ileocecal valve reconstruction)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| RISE anastomosis | Experimental | 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. Receives: Procedure: RISE (Revolute Insert Side-End ileocecal valve reconstruction) |
| Control | No intervention | Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after surgery
Secondary outcomes (12)
Operation time
Measured: during the surgery
anastomosis time
Measured: during surgery
intraoperative blood loss
Measured: during surgery
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
Measured: 30 days after surgery
anastomosis healing
Colonoscopy is used to assess the healing status of an anastomosis, and to determine whether stenosis, ulcers, or other pathological changes have occurred.
Measured: 3 months, 6 months and 1 year after surgery
albumin level
for assessing the nutritional status.
Measured: 3 days, 1 month, 3 months, 6 months and 1 year after surgery.
bile acid
for assessing the nutritional status.
Measured: 3 days, 1 month, 3 months, 6 months and 1 year after surgery
VitB12
for assessing the nutritional status.
Measured: 3 days, 1 month, 3 months, 6 months and 1 year after surgery
total protein
for assessing the nutritional status
Measured: 3 days, 1 month, 3 months, 6 months and 1 year after surgery
EORTCQLQ-C30
for assessing quality of life after surgery
Measured: baseline, 1 month after surgery.
EORTCQLQ-CR2930
for assessing quality of life after surgery
Measured: baseline, 1 month after surgery.
gut microbiota
Analyzing the changes in gut microbiota through the patient's fecal samples.
Measured: 1 month, 3 months, 6 months and 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right-sided Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Xiao, Army Medical University, China
- Investigators
- Weidong Xiao, MD, Principal investigator, Department of General Surgery, Xinqiao Hospital, Army Medical University, No.183 Xinqiao Road, Chongqing, 400037, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167420
- Sponsor's protocol ID
- RISE anastomosis 002
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the completion of this study, the data will be made public and anyone can request it by email.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07167420
- Acronym / sponsor ID
- RISE anastomosis 002
- Conditions
- Right-sided Colon Cancer
- Keywords
- right-sided colon cancer, laparoscopic surgery, ileocecal valve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RISE anastomosis | Experimental | 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. |
| Control | No intervention | –Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | RISE anastomosis |
Primary outcome
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.
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. After the completion of this study, the data will be made public and anyone can request it by email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weidong Xiao, MD principal investigator
Department of General Surgery, Xinqiao Hospital, Army Medical University, No.183 Xinqiao Road, Chongqing, 400037, China
Questions about this trial
What is this clinical trial studying?
A study testing RISE (Revolute Insert Side-End ileocecal valve reconstruction) in people with Right-sided Colon Cancer, run by Army Medical University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weidong Xiao, MD (86-13996390860, xiaoweidong@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first formed stool after surgery (Bristol stool score < 4). (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.