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Trial registered on ANZCTR


Registration number
ACTRN12610000006044
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
6/01/2010
Date last updated
6/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective randomized trial of single port laparoscopic cholecystectomy versus four ports laparoscopic cholecystectomy in patients with gallbladder stones
Scientific title
Prospective randomized trial of single port laparoscopic cholecystectomy versus four ports laparoscopic cholecystectomy in patients with gallbladder stones, to assess differences in pain
Secondary ID [1] 1220 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gallbladder stones 256446 0
Gallbladder polyps 256447 0
Condition category
Condition code
Surgery 256617 256617 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single port laparoscopic cholecystectomy:
All operations were performed under general anaesthesia in the supine position with the operating surgeon on the patient’s left side. The sub-umbilical incision 20 mm in size was made by open technique. SILS (trademark) Port (Covidien) was inserted then. The SILS (trademark) Port is a flexible laparoscopic port that can accommodate up to three instruments through a single incision. The abdominal cavity was insufflated to a pneumoperitoneum of 12mmHg, and a 30 degrees laparoscope was then inserted. The patients were placed in a reverse Trendelenburg position, with the right side elevated. Instruments were then inserted through the rest of two 5 mm channels. The principal of surgery is same as the conventional 4-ports approach. Calot’s triangle was retracted under the help of two slings of sutures over the fundus and Hartman’s pouch. The cystic artery was dissected and transected after bipolar diathermy coagulation. The cystic duct was dissected and transected after endo-clips or endo-tie control. The gallbladder was dissected from gallbladder bed. The specimen was placed inside the retrieval bag and removed through the sub-umbilical port.
Approximate duration 1 hour
Intervention code [1] 255684 0
Treatment: Surgery
Comparator / control treatment
Four ports laparoscopic cholecystectomy:
All operations were performed under general anaesthesia in the supine position with the operating surgeon on the patient’s left side. The sub-umbilical incision 10 mm in size was made by open technique. Trocar was inserted. The abdominal cavity was insufflated to a pneumoperitoneum of 12mmHg, and a 30 degrees laparoscope was then inserted. The patients were placed in a reverse Trendelenburg position, with the right side elevated. Under direct vision, three 5-mm trocars were then placed in the right subcostal region along anterior axillary, midclavicular lines and sub-xiphoid region. Two graspers were passed through the two lateral ports to retract the fundus and Hartmann’s pouch of the gall bladder. Instruments of matching calibre were used for the dissection around the Carlot’s triangle to expose both the cystic duct and cystic artery from the sub-xiphoid port. The cystic artery was dissected and transected after bipolar diathermy coagulation. The cystic duct was dissected and transected after endo-clips or endo-tie control. The gallbladder was dissected from gallbladder bed. The specimen was placed inside the retrieval bag and removed through the sub-umbilical port.
Approximate duration 1 hour
Control group
Active

Outcomes
Primary outcome [1] 257453 0
Pain score
Assessed by asking patient to rate score on a visual analog scale
Timepoint [1] 257453 0
6 hours after surgery
Postoperative 7 days
Secondary outcome [1] 262604 0
Open conversion rate
Assessed by operating surgeon during surgery whether conversion to open is necessary
Timepoint [1] 262604 0
Immediately during surgery
Secondary outcome [2] 262605 0
Complications of cholecystectomy: wound infection, postoperative hemorrhage, bile leak, dropped stone, major bile duct injury
Assessed from physical examination, blood tests, medical records
Timepoint [2] 262605 0
Immediately following surgery
Postoperative 7 days
Postoperative 1 month
Postoperative 6 months
Secondary outcome [3] 262606 0
Hospital mortality of cholecystectomy
Assessed from medical records
Timepoint [3] 262606 0
Postoperative 30 days
Secondary outcome [4] 262607 0
Hospital stay
Assessed from medical records
Timepoint [4] 262607 0
Immediately following surgery
Secondary outcome [5] 262608 0
Cosmetic satisfaction of the surgical scar
Assessed by asking patient to rate appearance of each incision on scale of 1 (worst) to 10 (best)
Timepoint [5] 262608 0
Postoperative 3 months
Secondary outcome [6] 262609 0
Interval for resumption of normal activities
Assessed by questionnaire
Timepoint [6] 262609 0
Postoperative 7 days
Postoperative 1 month

Eligibility
Key inclusion criteria
Age ranged from 18-80 years old
Patients with preoperative diagnosis of biliary colic, gallbladder polyps
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The American Society of Anesthesiologists'(ASA) physical status class IV and V
Patients with contraindication for laparoscopy
Patients with Mirizzi syndrome
Patient with suspected presence of common duct stones
Patients with suspected malignancy
Patients with previous upper abdominal surgery
Patients on long term anticoagulant treatment
Patients with previous history of cholangitis or cholecystitis
Patients with large gallstone >3cm
Patients with imaging diagnosis of contracted gallbladder or chronic cholecystitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be randomized in 1 of 2 groups (group A and B) using sealed opaque envelopes containing computer-generated random numbers.
Group A patients will undergo single port laparoscopic cholecystectomy.
Group B patients will undergo conventional 4-ports laparoscopic cholecystectomy.
The randomization is done only after full pretreatment investigations and consent to participate in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 2362 0
Hong Kong
State/province [1] 2362 0

Funding & Sponsors
Funding source category [1] 256168 0
Self funded/Unfunded
Name [1] 256168 0
Country [1] 256168 0
Primary sponsor type
Individual
Name
Yih Chun Ling Patricia
Address
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 251510 0
None
Name [1] 251510 0
Address [1] 251510 0
Country [1] 251510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258274 0
Ethics Committee, Hong Kong East Cluster
Ethics committee address [1] 258274 0
Ethics committee country [1] 258274 0
Hong Kong
Date submitted for ethics approval [1] 258274 0
22/10/2009
Approval date [1] 258274 0
26/11/2009
Ethics approval number [1] 258274 0
HKEC-2009-081

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30611 0
Address 30611 0
Country 30611 0
Phone 30611 0
Fax 30611 0
Email 30611 0
Contact person for public queries
Name 13858 0
Yih Chun Ling Patricia
Address 13858 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Hong Kong
Country 13858 0
Hong Kong
Phone 13858 0
(852)25956111
Fax 13858 0
Email 13858 0
ycl136@ha.org.hk
Contact person for scientific queries
Name 4786 0
Yih Chun Ling Patricia
Address 4786 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Hong Kong
Country 4786 0
Hong Kong
Phone 4786 0
(852)25956111
Fax 4786 0
Email 4786 0
ycl136@ha.org.hk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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