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 |
| Protocol serial number | 06/wmw01/55 |
| Sponsor | Carmarthenshire NHS Trust (UK) |
| Funder | Carmarthenshire NHS Trust (UK) - Research and Development Office (now known as Hywel Dda NHS Trust) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Gastrointestinal Surgery
Singleton Hospital
Abertawe Bro Morgannwg University NHS Trust
Sketty Lane
Swansea
SA2 8QA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Patient satisfaction in terms of wound appearance and wound closure technique. Measured at six weeks post-operatively. |
| Key secondary outcome measure(s) |
1. Wound closure time, measured at the time of operation |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
SA2 8QA
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2016: No publications found, verifying study status with principal investigator.