Under ALL circumstances, the principles in the Declaration of Helsinki MUST be complied
One of the colorectal specialists (Dr CC Chung, Dr KK Yau, Dr JCH Wong and Dr. HY S Cheung)
in the colorectal team will be informed. Clear explanation of the diagnosis, natural history
of the disease, different treatment options, their likely outcomes and potential
complications will be given. If the patient opts for surgical treatment, he/ she will be
invited to enter the study. Further explanation about the study will then be given. The
patient information sheet will be given. The patient will then be allowed with all the time
he/she needed for decision.
Randomization:
By drawing from concealed envelopes into either the "total lap" (Total laparoscopic right
hemicolectomy) or the "hand-assisted" (Hand-assisted laparoscopic right hemicolectomy)
groups
The Operation:
1. Patients were put on a liquid diet the day before operation. All received mechanical
bowel preparation the night before surgery,
2. Prophylactic antibiotics with be given:
Cefuroxime 1.5gm IVI Metronidazole 500mg IVI on induction
3. Operation should be performed by two of the following surgeons under general
anaesthesia:
Dr HYS Cheung Dr. JCH Wong Dr CC Chung Dr KK Yau
4. either Total laparoscopic right hemicolectomy or Hand-assisted right hemicolectomy will
be performed according to the randomization.
Standardized post-operative care:
1. All patients would receive patient control analgesia (PCA) in the form of intravenous
bolus morphine in the immediate postoperative period. The dosage and regimen were
reviewed by the anaesthetists in-charge, who would stop the PCA according to their
usual practice. Thereafter, Pethidine (1mg/kg) was given intramuscularly every 4 hours
on demand. In addition, two tablets of dologesic were prescribed orally every 4 hours
on demand;
2. Resume diet and off intravenous fluid as tolerated;
3. The pain score was recorded from postoperative day 1 to day 7
4. Date of ambulation, postoperative mortality and pathology were recorded.
Discharge Criteria:
1. Ambulatory (or resume the pre-operative motility status)
2. Free from any complications that required inpatient management
3. Had at least one bowel motion
4. Did not require parental analgesia
Follow Up Arrangement:
1. They were reviewed by clinical oncologists as outpatients, and adjuvant chemotherapy
were selectively offered based on the final histological staging of the disease
2. All patients were followed up in the surgical clinic according to the structured
proforma. They were followed up 4-monthly in the first 3 years, and 6-monthly
thereafter. CEA would be taken at each visit. CXR and ultrasound abdomen would be
analyzed annually. Surveillance colonoscopy would be analyzed every 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
operation time
minutes
No
Hester YS Cheung, FRACS
Principal Investigator
Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong
Hong Kong: Ethics Committee
CShan
NCT00485251
February 2007
September 2009
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