Radical Right HemicolectomyNCT07095985
Novel Ileocecal Valve-Sparing Anastomosis in Laparoscopic Right Hemicolectomy
An observational study of Radical Right Hemicolectomy, run by Army Medical University, China at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radical Right Hemicolectomy
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The patients who visited Xinqiao Hospital and were diagnosed with right-sided colon cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Radical Right Hemicolectomy
- Keywords
- Right hemicolectomy, Ileocecal valve reconstruction, RISE anastomosis, Laparoscopic surgery, Colon cancer, Anastomotic technique, Bowel function, Retrospective cohort study
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RISE anastomosis | Following right hemicolectomy, the novel RISE-ICVR technique involves everting the ileal stump to create an artificial valve, implanting it into a colonic wall incision, and securing it with circumferential sutures. | |
| Conventional Anastomosis Group | In contrast, the conventional approach uses a linear stapler to perform a side-to-side ileocolic anastomosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo).
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.
Measured: from day1 to day30 after surgery
Secondary outcomes (2)
Time to first flatus
Record the time of the patient's first bowel movement after surgery.
Measured: from day1 to day7 after surgery
Time to first formed stool
Record the time of the patient's first formed stool after surgery.
Measured: from day1 to day30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jul 2024
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radical Right HemicolectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
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, Study chair, Second Affiliated Hospital of Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095985
- Sponsor's protocol ID
- RISE anastomosis 001
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently planning to conduct a series of studies. As data sharing will be postponed until all studies have been completed, the data will not be made available at this time.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07095985
- Acronym / sponsor ID
- RISE anastomosis 001
- Conditions
- Radical Right Hemicolectomy
- Keywords
- Right hemicolectomy, Ileocecal valve reconstruction, RISE anastomosis, Laparoscopic surgery, Colon cancer, Anastomotic technique, Bowel function, Retrospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 31 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RISE anastomosis | – | –Following right hemicolectomy, the novel RISE-ICVR technique involves everting the ileal stump to create an artificial valve, implanting it into a colonic wall incision, and securing it with circumferential sutures. |
| Conventional Anastomosis Group | – | –In contrast, the conventional approach uses a linear stapler to perform a side-to-side ileocolic anastomosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who visited Xinqiao Hospital and were diagnosed with right-sided colon cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Time to first flatus
Time frame: from day1 to day7 after surgery
Time to first formed stool
Time frame: from day1 to day30 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. We are currently planning to conduct a series of studies. As data sharing will be postponed until all studies have been completed, the data will not be made available at this time.
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. This study is not recruiting at the moment.
Weidong Xiao, MD study chair
Second Affiliated Hospital of Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radical Right Hemicolectomy, run by Army Medical University, China at 1 site in 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 5 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative complications (anastomotic leak, bleeding, stricture), severe complications (Clavien-Dindo). (time frame: from day1 to day30 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 31 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.