Comparing laparoscopic ileocecal reconstruction versus traditional right hemicolectomy for right-sided colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Study coordinator: Chaoxi Zhou, MD
• Email: zhouchaoxi81@163.com
• Phone: +8615931121563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.