NCT07207317

LIRRH Trial for the Right-sided Colon Cancer

Laparoscopic Ileocecal Reconstruction Right Hemicolectomy (LIRRH) Trial for the Right-sided Colon Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chaoxi Zhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Ascending Colon Cancer
• Proximal Transverse Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	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	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-28
• Completion: 2028-04-28
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: China