A comparison of patient satisfaction and complications following keyhole surgery wounds closed with tissue glue or stitches

ISRCTN	ISRCTN80786695
DOI	https://doi.org/10.1186/ISRCTN80786695
Secondary identifying numbers	06/wmw01/55

Submission date: 27/11/2009
Registration date: 15/12/2009
Last edited: 20/05/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr William Beasley
Scientific

Department of Gastrointestinal Surgery
Singleton Hospital
Abertawe Bro Morgannwg University NHS Trust
Sketty Lane
Swansea
SA2 8QA
United Kingdom

Study information

Study design	Single blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Patient satisfaction and complications following laparoscopic wound closure with 2-octylcyanoacrylate or vicryl: a single blind randomised controlled trial
Study objectives	Closure of laparoscopic wounds with tissue adhesives is associated with higher patient satisfaction and lower complication rates than with conventional suturing.
Ethics approval(s)	Dyfed Powys Research Ethics Committee approved on the 3rd January 2007 (ref: 06/wmw01/55)
Health condition(s) or problem(s) studied	Laparoscopic general surgery
Intervention	Intervention: Laparoscopic wound closure with 2-cyanoacrylate tissue adhesive Control: Laparoscopic wound closure with subcuticular stitches Total follow up was six weeks.
Intervention type	Procedure/Surgery
Primary outcome measure	Patient satisfaction in terms of wound appearance and wound closure technique. Measured at six weeks post-operatively.
Secondary outcome measures	1. Wound closure time, measured at the time of operation 2. Wound complications (dehisence, infection, resuturing), measured at six weeks post-operatively 3. Wound pain, measured at six weeks post-operatively 4. Antibiotic usage, measured at the time of operation 5. Unscheduled medical review, measured at six weeks post-operatively
Overall study start date	01/02/2007
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. All adults (aged 18 years and over), both males and females 2. Elective, general surgical, laparoscopic patients
Key exclusion criteria	1. Known 2-octylcyanoacrylate hypersensitivity 2. Conversion to open procedure
Date of first enrolment	01/02/2007
Date of final enrolment	01/02/2009

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Gastrointestinal Surgery

Swansea
SA2 8QA
United Kingdom

Sponsor information

Carmarthenshire NHS Trust (UK)
Hospital/treatment centre

Research and Development Office
Room 8, Mynydd Mawr Hospital
Upper Tumble
Llanelli
SA14 6BU
Wales
United Kingdom

Phone	+44 (0)1269 833397
Email	ingaret.eden@carmarthen.wales.nhs.uk
Website	http://www.wales.nhs.uk/sites3/home.cfm?orgid=45

Funders

Funder type

Government

Carmarthenshire NHS Trust (UK) - Research and Development Office (now known as Hywel Dda NHS Trust)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/05/2016: No publications found, verifying study status with principal investigator.