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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITING3-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.
Time frame: From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months
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: %
Time frame: 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: %
Time frame: 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 (%)
Time frame: 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)
Time frame: 6 months and 1 year post-surgery
5-year overall survival
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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: %
Time frame: From randomization to death from any cause, assessed up to 60 months