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

Int Urogynecol J. 2015 Aug;26(8):1171-8. doi: 10.1007/s00192-015-2670-4. Epub 2015 Mar 20.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analgesics, Opioid
  • Anesthesia Recovery Period
  • Anesthesia, General* / adverse effects
  • Anesthesia, Spinal* / adverse effects
  • Anesthetics, Inhalation
  • Anesthetics, Intravenous
  • Anesthetics, Local
  • Bupivacaine
  • Feasibility Studies
  • Female
  • Fentanyl
  • Humans
  • Hysterectomy, Vaginal / adverse effects
  • Hysterectomy, Vaginal / methods*
  • Isoflurane
  • Length of Stay
  • Lumbosacral Region
  • Middle Aged
  • Pain, Postoperative / etiology
  • Pelvic Floor Disorders / surgery*
  • Postoperative Nausea and Vomiting / etiology
  • Propofol
  • Quality of Life
  • Recovery Room
  • Suburethral Slings* / adverse effects
  • Treatment Outcome
  • Vagina / surgery*

Substances

  • Analgesics, Opioid
  • Anesthetics, Inhalation
  • Anesthetics, Intravenous
  • Anesthetics, Local
  • Isoflurane
  • Fentanyl
  • Bupivacaine
  • Propofol

Associated data

  • ISRCTN/ISRCTN76637086