Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr SS Ching

ORCID ID

Contact details

D Floor
Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3922247
ching_ss@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436121394

Study information

Scientific title

Acronym

Study hypothesis

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

Added as of 29/04/2008:
Ethics approval received from the Leeds (West) Research Ethics Committee (ref: 03/009 and 04/Q1205/143).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Laparoscopy

Intervention

Randomised controlled trial. Random allocation to:
A. Longitudinal Mode Ultrasound
B. Torsional Mode Ultrasound

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/01/2003

Overall trial end date

14/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing laparoscopic cholecystectomy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160 (added 29/04/2008)

Participant 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

Recruitment start date

01/01/2003

Recruitment end date

14/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

D Floor, Clarendon Wing
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19263118

Publication citations

  1. Results

    Ching SS, Sarela AI, Hayden JD, McMahon MJ, Randomized clinical trial of torsional versus linear mode ultrasonically activated devices for laparoscopic cholecystectomy., Surg Endosc, 2009, 23, 7, 1506-1511, doi: 10.1007/s00464-009-0391-9.

Additional files

Editorial Notes