Prospective Randomized Trial of Hand-assisted Laparoscopic Right Hemicolectomy vs Total Laparoscopic Right Hemicolectomy
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|ClinicalTrials.gov Identifier: NCT00485251|
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : November 25, 2009
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:
- 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.
- 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 or disease||Intervention/treatment||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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||February 2007|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
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 operationProcedure: 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 abdomenProcedure: laparoscopic right hemicolectomy
using laparoscopic instruments for mobilization and dissection inside the abdomen
- operation time [ Time Frame: minutes ]
- pain score, recurrence [ Time Frame: pain score during postoperative hospital stay, recurrence for 5 years ]
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
|Pamela Youde Nethersole Eastern Hosptial|
|Hong Kong, Hong Kong|
|Principal Investigator:||Hester YS Cheung, FRACS||Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong|