Randomised clinical trial of longitudinal versus torsional mode ultrasound in laparoscopic cholecystectomy

ISRCTN	ISRCTN87527062
DOI	https://doi.org/10.1186/ISRCTN87527062
Protocol serial number	N0436121394
Sponsor	Department of Health (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 02/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr SS Ching
Scientific

D Floor, Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 3922247
Email	ching_ss@hotmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare torsional mode ultrasound with longitudinal mode ultrasound with regard to safety and efficiency in haemostatic cutting in laparoscopic surgery. Please note that this record has been updated as of 29/04/2008. All updates can be found in the relevant field, under the above date. Please also note that the anticipated end date of this trial has been updated to 14/11/2007. The previous anticipated end date was 01/09/2004.
Ethics approval(s)	Added as of 29/04/2008: Ethics approval received from the Leeds (West) Research Ethics Committee (ref: 03/009 and 04/Q1205/143).
Health condition(s) or problem(s) studied	Surgery: Laparoscopy
Intervention	Randomised controlled trial. Random allocation to: A. Longitudinal Mode Ultrasound B. Torsional Mode Ultrasound
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Current primary outcomes as of 29/04/2008: Operative blood loss, calculated within 24 hours post surgery. Previous primary outcomes: Operating time, blood loss, post operative complications.
Key secondary outcome measure(s)	Added as of 29/04/2008: 1. Gallbladder dissection time, measured during laparoscopic cholecystectomy 2. Gallbladder perforation rate, measured during laparoscopic cholecystectomy 3. Need for monopolar electrocoagulation, measured during laparoscopic cholecystectomy 4. Complications, recorded post-operatively
Completion date	14/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	160
Key inclusion criteria	Patients undergoing laparoscopic cholecystectomy.
Key exclusion criteria	Added as of 29/04/2008: 1. Oral anticoagulant treatment 2. Known coagulation disorder 3. American Society of Anaesthesiologists (ASA) grade 3 or more 4. Aged less than 16 years 5. Pregnancy 6. Mental illness 7. The need to explore the common bile duct at the time of surgery
Date of first enrolment	01/01/2003
Date of final enrolment	14/11/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

D Floor, Clarendon Wing

Leeds
LS1 3EX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009		Yes	No