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Prospective Randomized Trial of Hand-assisted Laparoscopic Right Hemicolectomy vs Total Laparoscopic Right Hemicolectomy

NCT00485251 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-11-25

No results posted yet for this study

Summary

The operation used for treating cancer in this location of the colon is called right hemicolectomy. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:

1. Total Laparoscopic right hemicolectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, a small wound was created for the delivery of bowel and extracorporeal anastomosis.
2. Hand-assisted laparoscopic right Hemicolectomy A 6.5cm incision is used to allow insertion of one of the surgeon's hands into the abdomen. The operation is completed by the surgeon's hand and laparoscopic instruments, using video laparoscopy.

These two operations are essentially identical except for the surgical access. Both total laparoscopic and Hand-assisted laparoscopic surgery has been practiced in the United States and Europe for over 10 years. Studies from the United State and Europe have demonstrated the safety and the benefits of both techniques in terms of pain and recovery. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.

The results of this study may have an impact on the care of similar patients in the future.

Conditions

  • Operation Time
  • Pain Score
  • Recurrence
  • Survival

Interventions

PROCEDURE

hand-assisted laparoscopic right hemicolectomy

using the lap disc that allows the insertion of single and into the abdomen for operation

PROCEDURE

total laparoscopic right hemicolectomy

using laparoscopic instruments for mobilization and dissection inside the abdomen

PROCEDURE

hand-assisted right hemicolectomy

hand-assisted right hemicolectomy

PROCEDURE

laparoscopic right hemicolectomy

using laparoscopic instruments for mobilization and dissection inside the abdomen

Sponsors & Collaborators

  • Pamela Youde Nethersole Eastern Hospital

    lead OTHER

Principal Investigators

  • Hester YS Cheung, FRACS · Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00485251 on ClinicalTrials.gov