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Phase 4
18 Years
Not Enrolling
Operation Time, Pain Score, Recurrence, Survival

Thank you

Trial Information

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.


By drawing from concealed envelopes into either the "total lap" (Total laparoscopic right
hemicolectomy) or the "hand-assisted" (Hand-assisted laparoscopic right hemicolectomy)

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

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.

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

- Patients with tumour size larger than 6.5cm in any dimension on preoperative imaging
or invasion to contiguous organs.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

operation time

Outcome Time Frame:


Safety Issue:


Principal Investigator

Hester YS Cheung, FRACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong


Hong Kong: Ethics Committee

Study ID:




Start Date:

February 2007

Completion Date:

September 2009

Related Keywords:

  • Operation Time
  • Pain Score
  • Recurrence
  • Survival
  • operation time in minutes
  • pain score from 1-10
  • recurrence
  • survival
  • Recurrence