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General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial

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Abstract

Introduction and hypothesis

Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes.

Methods

Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient’s subjective perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire.

Results

Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS.

Conclusion

This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

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Source funding

This study was funded by a Research Award from the North Staffordshire Medical Institute, UK.

Conflicts of interest

None.

Authors’ participation in the manuscript

B. Purwar: data collection, data analysis, manuscript writing and editing; K. Ismail: protocol development, data analysis, manuscript writing, editing and revision; N. Turner: protocol development, data analysis, manuscript writing and editing, anaesthetic provision, patient consent; A. Farrell: protocol development, anaesthetic provision, patient consent, manuscript writing and editing; M. Verzune: data collection, manuscript writing and editing; M. Annappa: data collection, consenting, manuscript writing and editing; I. Smith: protocol development, data analysis, manuscript writing, editing and revision; Z. El-Gizawy: protocol development, ethical submission, data collection; J. Cooper: study idea, protocol development, data analysis, manuscript writing, editing and revision, patient consent.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Royal Stoke University Hospital, Newcastle Road, Stoke-on-Trent, Staffordshire, ST4 6QG, UK

    B. Purwar, M. Verzune, Zeiad El-Gizawy & J. C. Cooper

  2. The Birmingham Centre for Women’s and Children’s Health, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

    K. M. Ismail

  3. Academic Unit, Birmingham Women’s NHS Foundation Trust, Edgbaston, Birmingham, B15 2TG, UK

    K. M. Ismail

  4. Department of Anaesthesia, Royal Stoke University Hospital, Staffordshire, UK

    N. Turner, A. Farrell & I. Smith

  5. Department of Obstetrics and Gynaecology, Diana, Princess of Wales Hospital, Bridgend, UK

    M. Annappa

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  1. B. Purwar
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Correspondence to J. C. Cooper.

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Purwar, B., Ismail, K.M., Turner, N. et al. General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial. Int Urogynecol J 26, 1171–1178 (2015). https://doi.org/10.1007/s00192-015-2670-4

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  • DOI: https://doi.org/10.1007/s00192-015-2670-4

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