Operation TimePhase 4NCT00485251
Prospective Randomized Trial of Hand-assisted Laparoscopic Right Hemicolectomy vs Total Laparoscopic Right Hemicolectomy
A Phase 4 study testing hand-assisted laparoscopic right hemicolectomy, total laparoscopic right hemicolectomy and hand-assisted right hemicolectomy in people with Operation Time and Pain Score, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Operation Time, Pain Score, Recurrence
- What is being tested?
- hand-assisted laparoscopic right hemicolectomy, total laparoscopic right hemicolectomy and hand-assisted right hemicolectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2007to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed to have operable carcinoma of caecum and ascending colon and hepatic flexure were potential candidates.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- Patients were put on a liquid diet the day before operation. All received mechanical bowel preparation the night before surgery,
- Prophylactic antibiotics with be given: Cefuroxime 1.5gm IVI Metronidazole 500mg IVI on induction
- 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
- either Total laparoscopic right hemicolectomy or Hand-assisted right hemicolectomy will be performed according to the randomization.
Standardized post-operative care:
- 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;
- Resume diet and off intravenous fluid as tolerated;
- The pain score was recorded from postoperative day 1 to day 7
- Date of ambulation, postoperative mortality and pathology were recorded.
Discharge Criteria:
- Ambulatory (or resume the pre-operative motility status)
- Free from any complications that required inpatient management
- Had at least one bowel motion
- Did not require parental analgesia
Follow Up Arrangement:
- They were reviewed by clinical oncologists as outpatients, and adjuvant chemotherapy were selectively offered based on the final histological staging of the disease
- 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
- Being tested
- hand-assisted laparoscopic right hemicolectomy, total laparoscopic right hemicolectomy, hand-assisted right hemicolectomy, laparoscopic right hemicolectomy
- Keywords
- operation time in minutes, pain score from 1-10, recurrence, survival
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand-assisted laparoscopic right hemicolectomyProcedure or surgery
using the lap disc that allows the insertion of single and into the abdomen for operation
total laparoscopic right hemicolectomyProcedure or surgery
using laparoscopic instruments for mobilization and dissection inside the abdomen
hand-assisted right hemicolectomyProcedure or surgery
hand-assisted right hemicolectomy
laparoscopic right hemicolectomyProcedure or surgery
using laparoscopic instruments for mobilization and dissection inside the abdomen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | hand assisted right hemicolectomy Receives: Procedure: hand-assisted laparoscopic right hemicolectomy; Procedure: hand-assisted right hemicolectomy |
| 2 | Active comparator | laparoscopic right hemicolectomy Receives: Procedure: total laparoscopic right hemicolectomy; Procedure: laparoscopic right hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
Measured: minutes
Secondary outcomes (1)
pain score, recurrence
Measured: pain score during postoperative hospital stay, recurrence for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operation TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hester YS Cheung, FRACS, Principal investigator, Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485251
- Sponsor's protocol ID
- CShan
- Status last verified
- Nov 2009
- First submitted
- 11 Jun 2007
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Hand-assisted Laparoscopic Right Hemicolectomy vs Total Laparoscopic Right Hemicolectomy
- ClinicalTrials.gov ID
- NCT00485251
- Acronym / sponsor ID
- CShan
- Conditions
- Operation Time, Pain Score, Recurrence, Survival
- Keywords
- operation time in minutes, pain score from 1-10, recurrence, survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Patients were put on a liquid diet the day before operation. All received mechanical bowel preparation the night before surgery,
- Prophylactic antibiotics with be given: Cefuroxime 1.5gm IVI Metronidazole 500mg IVI on induction
- 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
- either Total laparoscopic right hemicolectomy or Hand-assisted right hemicolectomy will be performed according to the randomization.
Standardized post-operative care:
- 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;
- Resume diet and off intravenous fluid as tolerated;
- The pain score was recorded from postoperative day 1 to day 7
- Date of ambulation, postoperative mortality and pathology were recorded.
Discharge Criteria:
- Ambulatory (or resume the pre-operative motility status)
- Free from any complications that required inpatient management
- Had at least one bowel motion
- Did not require parental analgesia
Follow Up Arrangement:
- They were reviewed by clinical oncologists as outpatients, and adjuvant chemotherapy were selectively offered based on the final histological staging of the disease
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: hand-assisted laparoscopic right hemicolectomy, Procedure: hand-assisted right hemicolectomyhand assisted right hemicolectomy |
| 2 | Active comparator | Procedure: total laparoscopic right hemicolectomy, Procedure: laparoscopic right hemicolectomylaparoscopic right hemicolectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient diagnosed to have operable carcinoma of caecum and ascending colon and hepatic flexure were potential candidates.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand-assisted laparoscopic right hemicolectomyusing the lap disc that allows the insertion of single and into the abdomen for operation | Procedure or surgery | 1 |
| total laparoscopic right hemicolectomyusing laparoscopic instruments for mobilization and dissection inside the abdomen | Procedure or surgery | 2 |
| hand-assisted right hemicolectomyhand-assisted right hemicolectomy | Procedure or surgery | 1 |
| laparoscopic right hemicolectomyusing laparoscopic instruments for mobilization and dissection inside the abdomen | Procedure or surgery | 2 |
Primary outcome
operation time
Time frame: minutes
1 secondary outcome
pain score, recurrence
Time frame: pain score during postoperative hospital stay, recurrence for 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hester YS Cheung, FRACS principal investigator
Department of Surgery, Pamela Youde Nethersole Eastern Hosptial, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hand-assisted laparoscopic right hemicolectomy, total laparoscopic right hemicolectomy and hand-assisted right hemicolectomy in people with Operation Time and Pain Score, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.