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

NCT ID: NCT00485251

Last Updated: 2009-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Operation Time; Pain Score; Recurrence; Survival

Keywords

operation time in minutes; pain score from 1-10; recurrence; survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

hand assisted right hemicolectomy

Group Type: ACTIVE_COMPARATOR

hand-assisted laparoscopic right hemicolectomy

Intervention Type: PROCEDURE

using the lap disc that allows the insertion of single and into the abdomen for operation

hand-assisted right hemicolectomy

Intervention Type: PROCEDURE

hand-assisted right hemicolectomy

2

laparoscopic right hemicolectomy

Group Type: ACTIVE_COMPARATOR

total laparoscopic right hemicolectomy

Intervention Type: PROCEDURE

using laparoscopic instruments for mobilization and dissection inside the abdomen

laparoscopic right hemicolectomy

Intervention Type: PROCEDURE

using laparoscopic instruments for mobilization and dissection inside the abdomen

Interventions

hand-assisted laparoscopic right hemicolectomy

using the lap disc that allows the insertion of single and into the abdomen for operation

Intervention Type: PROCEDURE

total laparoscopic right hemicolectomy

using laparoscopic instruments for mobilization and dissection inside the abdomen

Intervention Type: PROCEDURE

hand-assisted right hemicolectomy

hand-assisted right hemicolectomy

Intervention Type: PROCEDURE

laparoscopic right hemicolectomy

using laparoscopic instruments for mobilization and dissection inside the abdomen

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Hester YS Cheung, FRACS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Pamela Youde Nethersole Eastern Hosptial

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

CShan

Identifier Type: -

Identifier Source: org_study_id