Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon

Study Overview
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Brief Summary
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To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Detailed Description
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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

Official Title
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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

Conditions
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Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer

Intervention / Treatment
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* Procedure: laparoscopic ileocecus-sparing right hemicolectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suitable for curative surgery 18-75years old ASA grade I-III Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery); Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm. Informed consent Exclusion Criteria: Simultaneous or metachronous multiple primary colorectal cancer; History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery. Distant metastasis. History of any other malignant tumor in recent 5 years. Patients need emergency operation. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). Informed consent refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LISRH group<br>Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies. | Procedure: laparoscopic ileocecus-sparing right hemicolectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded | up to 90 days after surgery | 
| 1-year local recurrence | rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein, | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to conventional right hemicolectomy | the rate of conversion to conventional right hemicolectomy | 1 day of surgery | 
| Time to first flatus after surgery | days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery | up to 7 days after surgery | 
| Number of harvested lymph nodes | Number of harvested Lymph nodes according to the pathological report | up to 1 week after surgery | 
| R0 resection | Rate of resection without any affected margins during the surgical procedure according to the pathological report | up to 1 week after surgery | 
| Specimen morphometry | The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length | within 30 days | 
| 3-year disease free survival | the time from enrollment until disease relapse or death from any cause 3 years after surgery | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy