Condition category
Surgery
Date applied
09/02/2012
Date assigned
28/03/2012
Last edited
18/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jason Cooper

ORCID ID

Contact details

Maternity Centre
University Hospital of North Staffordshire
Stoke-on-Trent
ST4 6QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

Scientific title

A pilot study comparing general versus spinal anaesthesia for vaginal surgery: a randomised controlled trial

Acronym

GOSIP

Study hypothesis

There is no difference in postoperative outcomes with either spinal or general anaesthesia in gynaecological pelvic surgery.

Ethics approval

NRES Committee West Midlands, 01 July 2011 ref: 11/WM/0044

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to requesta patient information leaflet

Condition

Anaesthesia in gynaecological pelvic surgery

Intervention

Spinal or general anaesthesia

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2012

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All women undergoing vaginal surgery for incontinence or prolapse, no age criteria, all patients eligible

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Lack of capacity to give consent
2. Inability to read and write English

Recruitment start date

01/02/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Staffordshire
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

University Hospital of North Staffordshire (UK)

Sponsor details

R&D Department
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
+44 (0)1782 715444
darren.clement@uhns.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhns.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

North Staffordshire Medical Institute (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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25792351

Publication citations

Additional files

Editorial Notes

18/04/2016: Publication reference added.