Recurrence Clinical Trial
Verified date | November 2009 |
Source | Pamela Youde Nethersole Eastern Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Pamela Youde Nethersole Eastern Hosptial | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Pamela Youde Nethersole Eastern Hospital |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | operation time | minutes | No | |
Secondary | pain score, recurrence | pain score during postoperative hospital stay, recurrence for 5 years | No |
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