Ascending Colon CancerLIRRHNCT07207317
LIRRH Trial for the Right-sided Colon Cancer
A study testing Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH) and traditional laparoscopic right hemicolectomy (TRH) in people with Ascending Colon Cancer and Proximal Transverse Colon Cancer, run by Chaoxi Zhou at 1 site in China.
Trial summary
The aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicolectomy (TRH) for ascending and proximal transverse colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ascending Colon Cancer, Proximal Transverse Colon Cancer
- What is being tested?
- Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH) and traditional laparoscopic right hemicolectomy (TRH)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 28 Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- ASA physical status ≤ III
- Endoscopy and biopsy-proven colon adenocarcinoma
- Contrast-enhanced abdominal CT showing primary tumor located in the ascending colon or proximal transverse colon (proximal one-third)
- Pre-operative clinical stage: TanyNanyM0
- Able to understand the study protocol, willing to participate, and provide written informed consent
Who cannot join
- History of hypertensive crisis or hypertensive encephalopathy.
- Severe cardiopulmonary insufficiency or any other contraindication to surgery.
- Uncorrectable electrolyte disturbances (e.g., potassium, calcium, magnesium).
- Evidence of significant bleeding diathesis or high hemorrhagic risk:
- Prior intracranial or intraspinal hemorrhage.
- Tumor invading major vessels with obvious bleeding risk.
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- Thrombotic or embolic event within 6 months before study treatment, or significant vascular disease (e.g., surgical-repair aortic aneurysm).
- Clinically relevant hemoptysis or tumor bleeding of any cause within 1 month before screening.
- Therapeutic-dose anticoagulation within 2 weeks before study treatment (except low-molecular-weight heparin).
- Antiplatelet therapy within 10 days before study treatment (e.g., aspirin > 325 mg/day, clopidogrel > 75 mg/day, dipyridamole, ticlopidine, cilostazol).
- Active tuberculosis.
- Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to SLE, RA, autoimmune hepatitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyper- or hypothyroidism, asthma requiring bronchodilators).
- Pre-operative evidence of synchronous multiple primary colorectal cancers or other conditions requiring additional bowel resection.
- Pre-operative imaging or intra-operative findings showing:
- Tumor infiltration into adjacent organs requiring multi-visceral resection;
- Distant metastasis;
- Unresectable (unable to achieve R0) disease.
- Other malignancies within the past 5 years, or familial adenomatous polyposis; except cured carcinoma in situ of the cervix, basal-cell carcinoma, papillary thyroid carcinoma, or cutaneous squamous-cell carcinoma.
- Intestinal obstruction, perforation, or bleeding requiring emergency surgery.
- Patient unsuitable or unable to tolerate laparoscopic surgery.
- Pregnant or lactating women.
- History of psychiatric disorders precluding compliance.
- Prior neoadjuvant therapy.
- Multidisciplinary team (MDT) decision that the patient is not appropriate for the study.
- Patient unable to understand the study conditions/objectives and refuses to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Chaoxi Zhou, MD, PhD, +8615931121563, zhoutide@163.com
Meng Zesong, MS, mengzesongming@163.com
About this study
Official title: Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer
The aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicolectomy (TRH) for ascending and proximal transverse colon cancer.
Read the detailed description
This is a prospective, single-center, open-label, randomized controlled clinical trial. Eligible patients will be randomly assigned (1:1) to undergo either LIRRH or TRH and will receive the corresponding surgical procedure.
Primary endpoint: 3-year disease-free survival (DFS).
Secondary endpoints:
- Complications within 90 days postoperatively;
- Pathology-related indicators, including positive margin rate, number of harvested lymph nodes, and lymph-node metastasis rate;
- Assessment of postoperative intestinal microbiota changes;
- 5-year overall survival (OS).
- Being tested
- Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH), traditional laparoscopic right hemicolectomy (TRH)
- Keywords
- Right-sided colon cancer, Laparoscopic right hemicolectomy, Ileocecal reconstruction, Randomized controlled trial, Disease-free survival, TRH, LIRRH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH)Procedure or surgery
The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are also divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal region. After tailoring the ileal mesentery, an end-to-end ileo-transverse colonic anastomosis is performed. Using a seromuscular suture, the ileum and its tailored mesentery are invaginated into the wall of the transverse colon 2 cm proximal to the anastomosis, thereby reconstructing the ileocecal valve complex.
traditional laparoscopic right hemicolectomy (TRH)Procedure or surgery
The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are likewise divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal junction. An end-to-side or side-to-side ileo-transverse colonic anastomosis is then performed.
| Study group | Role | What they receive |
|---|---|---|
| LIRRH group | Experimental | Participants will undergo laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH), in which the ileocecal junction is reconstructed; procedure follows the same oncologic resection margins as standard laparoscopic surgery. Receives: Procedure: Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH) |
| TRH group | Active comparator | Participants will undergo traditional laparoscopic right hemicolectomy (TRH) with standard en-bloc mesenteric resection and ileocolic anastomosis Receives: Procedure: traditional laparoscopic right hemicolectomy (TRH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival (DFS)
DFS is defined as the time from randomization to the earliest date of locoregional recurrence, distant metastasis, second primary colorectal cancer, or death from any cause, whichever occurs first.
Measured: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months
Secondary outcomes (5)
10-day postoperative diarrhea rate
The proportion of patients experiencing diarrhea within 10 days after surgery, graded by the Clavien-Dindo classification system.
Unit of Measure: %
Measured: Within 10 days after surgery
15-day postoperative ileus rate
The proportion of patients experiencing ileus within 15 days after surgery, graded by the Clavien-Dindo classification system.
Unit of Measure: %
Measured: 15 days after surgery
Pathology-related composite indicator
A composite indicator related to pathology, including the positive margin rate, the number of harvested lymph nodes, and the lymph node metastasis rate. These indicators will be aggregated into a single reported value through a composite score or statistical analysis.
Unit of Measure: Composite score or percentage (%)
Measured: Immediate (on specimen examination, within 7 days post-op)
Postoperative gut microbiota diversity
The diversity of gut microbiota assessed by 16S rRNA gene sequencing at 6 months and 1 year post-surgery. The primary metrics include the Shannon diversity index and the Chao1 richness index.
Unit of Measure: Shannon diversity index (dimensionless) and Chao1 richness index (number of OTUs)
Measured: 6 months and 1 year post-surgery
5-year overall survival
Overall survival (OS) is defined as the time from randomization to death from any cause; survivors will be censored at the last follow-up. Unit of Measure: %
Measured: From randomization to death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 May 2025
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending 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
- Model description
- Participants are randomized 1:1 to either the LIRRH arm or the TRH arm and followed in parallel until completion of the trial; no crossover or factorial design is employed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaoxi Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chaoxi Zhou, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207317
- Sponsor's protocol ID
- 2025KS060
- Other IDs
- 2025KS060
- Acronym
- LIRRH
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following de-identified individual participant data will be shared: baseline demographics, operative variables, pathologic staging, adjuvant therapy details, recurrence and survival outcomes, and serious adverse events. Data will be provided in CSV format with a data dictionary and variable coding manual.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer
- ClinicalTrials.gov ID
- NCT07207317
- Acronym / sponsor ID
- LIRRH / 2025KS060
- Keywords
- Right-sided colon cancer, Laparoscopic right hemicolectomy, Ileocecal reconstruction, Randomized controlled trial, Disease-free survival, TRH, LIRRH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chaoxi ZhouUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 3 Oct 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 aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicolectomy (TRH) for ascending and proximal transverse colon cancer.
Detailed description
This is a prospective, single-center, open-label, randomized controlled clinical trial. Eligible patients will be randomly assigned (1:1) to undergo either LIRRH or TRH and will receive the corresponding surgical procedure.
Primary endpoint: 3-year disease-free survival (DFS).
Secondary endpoints:
- Complications within 90 days postoperatively;
- Pathology-related indicators, including positive margin rate, number of harvested lymph nodes, and lymph-node metastasis rate;
- Assessment of postoperative intestinal microbiota changes;
- 5-year overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to either the LIRRH arm or the TRH arm and followed in parallel until completion of the trial; no crossover or factorial design is employed.
| Arm | Type | Receives |
|---|---|---|
| LIRRH group | Experimental | Procedure: Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH)Participants will undergo laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH), in which the ileocecal junction is reconstructed; procedure follows the same oncologic resection margins as standard laparoscopic surgery. |
| TRH group | Active comparator | Procedure: traditional laparoscopic right hemicolectomy (TRH)Participants will undergo traditional laparoscopic right hemicolectomy (TRH) with standard en-bloc mesenteric resection and ileocolic anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years
- ASA physical status ≤ III
- Endoscopy and biopsy-proven colon adenocarcinoma
- Contrast-enhanced abdominal CT showing primary tumor located in the ascending colon or proximal transverse colon (proximal one-third)
- Pre-operative clinical stage: TanyNanyM0
Key exclusion criteria (25 listed)
- History of hypertensive crisis or hypertensive encephalopathy.
- Severe cardiopulmonary insufficiency or any other contraindication to surgery.
- Uncorrectable electrolyte disturbances (e.g., potassium, calcium, magnesium).
- Evidence of significant bleeding diathesis or high hemorrhagic risk:
- Prior intracranial or intraspinal hemorrhage.
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 |
|---|---|---|
| Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH)The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are also divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal region. After tailoring the ileal mesentery, an end-to-end ileo-transverse colonic anastomosis is performed. Using a seromuscular suture, the ileum and its tailored mesentery are invaginated into the wall of the transverse colon 2 cm proximal to the anastomosis, thereby reconstructing the ileocecal valve complex. | Procedure or surgery | LIRRH group |
| traditional laparoscopic right hemicolectomy (TRH)The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are likewise divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal junction. An end-to-side or side-to-side ileo-transverse colonic anastomosis is then performed. | Procedure or surgery | TRH group |
Primary outcome
3-year disease-free survival (DFS)
Time frame: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months
DFS is defined as the time from randomization to the earliest date of locoregional recurrence, distant metastasis, second primary colorectal cancer, or death from any cause, whichever occurs first.
5 secondary outcomes
10-day postoperative diarrhea rate
Time frame: Within 10 days after surgery
15-day postoperative ileus rate
Time frame: 15 days after surgery
Pathology-related composite indicator
Time frame: Immediate (on specimen examination, within 7 days post-op)
Postoperative gut microbiota diversity
Time frame: 6 months and 1 year post-surgery
5-year overall survival
Time frame: From randomization to death from any cause, assessed up to 60 months
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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. The following de-identified individual participant data will be shared: baseline demographics, operative variables, pathologic staging, adjuvant therapy details, recurrence and survival outcomes, and serious adverse events. Data will be provided in CSV format with a data dictionary and variable coding manual.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH) and traditional laparoscopic right hemicolectomy (TRH) in people with Ascending Colon Cancer and Proximal Transverse Colon Cancer, run by Chaoxi Zhou 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 6 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 3 Oct 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?
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 Chaoxi Zhou, MD (+8615931121563, zhouchaoxi81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (DFS) (time frame: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months). 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 3 Oct 2025.