LIRRH Trial for the Right-sided Colon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChaoxi Zhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
History of hypertensive crisis or hypertensive encephalopathy.
Severe cardiopulmonary insufficiency or any other contraindication to surgery.
Uncorrectable electrolyte disturbances (e.g., potassium, calcium, magnesium).
Prior intracranial or intraspinal hemorrhage.
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH)
Procedure/SurgeryThe 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.
traditional laparoscopic right hemicolectomy (TRH)
Procedure/SurgeryThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: LIRRH groupExperimental treatment 1 intervention
Group B: TRH groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-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 monthsSecondary outcomes
1
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 surgery2
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 surgery3
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)4
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-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Chaoxi Zhou
Lead sponsor
Hebei Medical University Fourth Hospital
Sponsor institution
Source ClinicalTrials.gov