A pilot study comparing general versus spinal anaesthesia for vaginal surgery
| ISRCTN | ISRCTN76637086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76637086 |
| Secondary identifying numbers | 01 |
- Submission date
- 09/02/2012
- Registration date
- 28/03/2012
- Last edited
- 18/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The purpose of this study is to examine the effect of anaesthetic technique (spinal or general anaesthesia) on the outcomes of vaginal surgery. Currently both forms of anaesthetic are in common practice with no knowledge of which is the best way to anaesthetise patients when having this surgery. Gynaecological vaginal surgery for urinary incontinence or vaginal prolapse is very common; some estimate that 11% of all women will have a prolapse operation by the age of 80. Knowledge of the right sort of anaesthetic may therefore help inform a large number of people on safety and side effects.
Who can participate?
All women who are undergoing vaginal surgery for prolapse or incontinence in our institution are eligible to participate. There are no age restrictions.
What does the study involve?
The study involves participants being randomly allocated to either a general or spinal anaesthetic and then taking part in an assessment of a number of factors. Participants will assess pain control before the operation, at 2 and 24 hours after surgery and at 2, 6 and 12 weeks following surgery using a visual chart. We will assess postoperative pain relief requirements as a secondary pain measure. We will also look at any complications of each anaesthetic technique, time of return to normal function, outcome of the operative procedure and patient satisfaction using a questionnaire that will be posted to participants.
What are the possible benefits and risks of participating?
The benefit of participating is to help inform patients of the future. Both techniques are in common and safe usage already so there are no extra risks involved. The risks are therefore those of anaesthesia already in use. These include nausea and vomiting, sore throat, backache, residual sleepiness and headache, need for intraoperative interventions, intraoperative pain, need for intraoperative sedation, and failure to establish a satisfactory spinal block and/or need to convert to general anaesthesia, or difficulty in establishing an airway.
Where is the study run from?
The study is run from the University Hospital of North Staffordshire in the UK.
When is the study starting and how long is it expected to run for?
It is anticipated it will run for one year commencing February 2012.
Who is funding the study?
It is being funded by a grant from the North Staffordshire Medical Institute, UK.
Who is the main contact?
Mr Jason Cooper
Jason.cooper@uhns.nhs.uk
Contact information
Scientific
Maternity Centre
University Hospital of North Staffordshire
Stoke-on-Trent
ST4 6QG
United Kingdom
Study information
| Study design | 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 requesta patient information leaflet |
| Scientific title | A pilot study comparing general versus spinal anaesthesia for vaginal surgery: a randomised controlled trial |
| Study acronym | GOSIP |
| Study objectives | There is no difference in postoperative outcomes with either spinal or general anaesthesia in gynaecological pelvic surgery. |
| Ethics approval(s) | NRES Committee West Midlands, 01 July 2011 ref: 11/WM/0044 |
| Health condition(s) or problem(s) studied | Anaesthesia in gynaecological pelvic surgery |
| Intervention | Spinal or general anaesthesia |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Postoperative pain assessed by 100mm visual analogue scale (VAS) performed at preoperative baseline, at 2 and 24 hours after surgery and at 2, 6 and 12 weeks following surgery |
| Secondary outcome measures | 1. Possible complications of anaesthetic technique 2. Time to return to normal function will include postoperative recovery room stay, time to fitness for hospital discharge and SF 36 questionnaire at 12 weeks (compared to a preoperative baseline) 3. Surgical outcome will be assessed by comparing results on the Vaginal Symptoms Questionnaire at 12 weeks with preoperative baseline |
| Overall study start date | 01/02/2012 |
| Completion date | 01/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | All women undergoing vaginal surgery for incontinence or prolapse, no age criteria, all patients eligible |
| Key exclusion criteria | 1. Lack of capacity to give consent 2. Inability to read and write English |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ST4 6QG
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
Newcastle Road
Stoke-on-Trent
ST4 6QG
England
United Kingdom
| Phone | +44 (0)1782 715444 |
|---|---|
| darren.clement@uhns.nhs.uk | |
| Website | http://www.uhns.nhs.uk |
Funders
Funder type
Hospital/treatment centre
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
Editorial Notes
18/04/2016: Publication reference added.
