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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485251
First Posted: June 12, 2007
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pamela Youde Nethersole Eastern Hospital
  Purpose

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.


Condition Intervention Phase
Operation Time Pain Score Recurrence Survival Procedure: hand-assisted laparoscopic right hemicolectomy Procedure: total laparoscopic right hemicolectomy Procedure: hand-assisted right hemicolectomy Procedure: laparoscopic right hemicolectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Pamela Youde Nethersole Eastern Hospital:

Primary Outcome Measures:
  • operation time [ Time Frame: minutes ]

Secondary Outcome Measures:
  • pain score, recurrence [ Time Frame: pain score during postoperative hospital stay, recurrence for 5 years ]

Estimated Enrollment: 60
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
hand assisted right hemicolectomy
Procedure: hand-assisted laparoscopic right hemicolectomy
using the lap disc that allows the insertion of single and into the abdomen for operation
Procedure: hand-assisted right hemicolectomy
hand-assisted right hemicolectomy
Active Comparator: 2
laparoscopic right hemicolectomy
Procedure: total laparoscopic right hemicolectomy
using laparoscopic instruments for mobilization and dissection inside the abdomen
Procedure: laparoscopic right hemicolectomy
using laparoscopic instruments for mobilization and dissection inside the abdomen

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient diagnosed to have operable carcinoma of caecum and ascending colon and hepatic flexure were potential candidates.

Exclusion Criteria:

  • Patient who did not give informed consent;
  • Patient who were considered unfit for operative treatment;
  • Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
  • Patients with metastatic diseases on preoperative work up;
  • Patient with synchronous tumours or polyps which necessitate extended or additional resection;
  • Patients with tumour size larger than 6.5cm in any dimension on preoperative imaging or invasion to contiguous organs.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485251


Locations
Hong Kong
Pamela Youde Nethersole Eastern Hosptial
Hong Kong, Hong Kong
Sponsors and Collaborators
Pamela Youde Nethersole Eastern Hospital
Investigators
Principal Investigator: Hester YS Cheung, FRACS Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong
  More Information

Responsible Party: Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT00485251     History of Changes
Other Study ID Numbers: CShan
First Submitted: June 11, 2007
First Posted: June 12, 2007
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Pamela Youde Nethersole Eastern Hospital:
operation time in minutes
pain score from 1-10
recurrence
survival

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes