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

This study has been completed.
Sponsor:
Information provided by:
Pamela Youde Nethersole Eastern Hospital
ClinicalTrials.gov Identifier:
NCT00485251
First received: June 11, 2007
Last updated: November 23, 2009
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • operation time [ Time Frame: minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain score, recurrence [ Time Frame: pain score during postoperative hospital stay, recurrence for 5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT00485251     History of Changes
Other Study ID Numbers: CShan
Study First Received: June 11, 2007
Last Updated: November 23, 2009
Health Authority: Hong Kong: Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014