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

Not Applicable

Completed

• Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer
• Interventions: Procedure: laparoscopic ileocecus-sparing right hemicolectomy

• Registration Number: NCT04479111
• Lead Sponsor: Zhejiang University

Brief Summary

To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Detailed Description

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

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients suitable for curative surgery 18-75years old
2. ASA grade I-III
3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
6. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
7. Informed consent

Exclusion Criteria

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
3. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
4. Distant metastasis.
5. History of any other malignant tumor in recent 5 years.
6. Patients need emergency operation.
7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
8. Informed consent refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LISRH group	laparoscopic ileocecus-sparing right hemicolectomy	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.

Primary Outcome Measures

Name	Time	Method
1-year local recurrence	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,
Postoperative complications	up to 90 days after surgery	Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China