Comparing laparoscopic ileocecal reconstruction versus traditional right hemicolectomy for right-sided colon cancer
Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer
This trial will see if laparoscopic ileocecal reconstruction right hemicolectomy leads to better cancer-free survival and fewer complications than traditional laparoscopic right hemicolectomy in adults with ascending or proximal transverse colon cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT07207317 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, open-label randomized trial that assigns eligible adults with biopsy-proven ascending or proximal transverse colon adenocarcinoma 1:1 to receive either laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) or traditional laparoscopic right hemicolectomy (TRH). The primary endpoint is three-year disease-free survival, with secondary endpoints including 90-day postoperative complications, pathology metrics (margin status, number of harvested lymph nodes, lymph-node metastasis rate), postoperative intestinal microbiota changes, and five-year overall survival. Eligible patients are 18–75 years old, clinical stage TanyNanyM0, and medically fit for laparoscopic surgery (ASA ≤ III). Surgical teams perform the assigned laparoscopic procedures and patients are followed longitudinally for oncologic and functional outcomes.
Who should consider this trial
Good fit: Adults 18–75 with endoscopy- and biopsy-confirmed adenocarcinoma located in the ascending colon or proximal third of the transverse colon, non-metastatic disease (TanyNanyM0), and fit for laparoscopic surgery (ASA ≤ III) are ideal candidates.
Not a fit: Patients with metastatic disease, severe cardiopulmonary insufficiency or other contraindications to surgery, uncorrectable electrolyte disturbances, high bleeding risk, or tumors invading major vessels are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, LIRRH could improve disease-free survival and reduce short-term complications or better preserve gut function compared with standard TRH.
How similar studies have performed: Traditional laparoscopic right hemicolectomy is well established, but randomized evidence directly comparing LIRRH to TRH is limited, so this specific reconstruction approach remains relatively unproven in controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shijiazhuang, Hebei
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Study coordinator: Chaoxi Zhou, MD
- Email: zhouchaoxi81@163.com
- Phone: +8615931121563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.