LIRRH Trial for the Right-sided Colon Cancer

Not Applicable

Recruiting

• Conditions: Ascending Colon Cancer; Proximal Transverse Colon Cancer

• Registration Number: NCT07207317
• Lead Sponsor: Chaoxi Zhou

Brief 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.

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:

1. Complications within 90 days postoperatively;

2. Pathology-related indicators, including positive margin rate, number of harvested lymph nodes, and lymph-node metastasis rate;

3. Assessment of postoperative intestinal microbiota changes;

4. 5-year overall survival (OS).

Study Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2027-04-28
• Study Completion: 2028-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival (DFS)	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.

Secondary Outcome Measures

Name	Time	Method
10-day postoperative diarrhea rate	Within 10 days after surgery	The proportion of patients experiencing diarrhea within 10 days after surgery, graded by the Clavien-Dindo classification system.; Unit of Measure: %
15-day postoperative ileus rate	15 days after surgery	The proportion of patients experiencing ileus within 15 days after surgery, graded by the Clavien-Dindo classification system.; Unit of Measure: %
Pathology-related composite indicator	Immediate (on specimen examination, within 7 days post-op)	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 (%)
Postoperative gut microbiota diversity	6 months and 1 year post-surgery	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)
5-year overall survival	From randomization to death from any cause, assessed up to 60 months	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: %

Trial Locations

Locations (1)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China