The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT04479111
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
Time frame: up to 90 days after surgery
Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded
Time frame: 7 days after surgery
rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,
Time frame: 1 day of surgery
the rate of conversion to conventional right hemicolectomy
Time frame: up to 7 days after surgery
days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery
Time frame: up to 1 week after surgery
Number of harvested Lymph nodes according to the pathological report
Time frame: up to 1 week after surgery
Rate of resection without any affected margins during the surgical procedure according to the pathological report
Time frame: within 30 days
The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
Time frame: 3 years
the time from enrollment until disease relapse or death from any cause 3 years after surgery
Zhejiang University
Other
An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
Acronym: LISH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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