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

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Zhejiang University

Status

Completed

Conditions

Hepatic Flexure Colon Cancer
Proximal Transverse Colon Cancer

Treatments

Procedure: laparoscopic ileocecus-sparing right hemicolectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04479111
CRCCZ-S02

Details and patient eligibility

About

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

Full 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

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

LISRH group
Experimental group
Description:
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.
Treatment:
Procedure: laparoscopic ileocecus-sparing right hemicolectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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