title: The effect of vaginal closure technique on early post-operative pain following vaginal prolapse surgery: a feasibility pilot study and qualitative assessment.
abstract: BACKGROUND
  Surgery for pelvic organ prolapse is a common surgical procedure. There is little research studying post-operative pain, contrasting with extensive literature on pain after childbirth trauma which shows that suture method has a significant effect on pain. We designed a protocol for a trial comparing suture techniques and post-operative pain, and conducted a pre-protocol pilot to inform our trial design.
  
  
  METHODS
  Routine surgical data, post-operative pain scores (from 10 cm Visual Analogue Scales, VAS) and analgesic requirements were obtained from the notes of a cohort of women undergoing vaginal prolapse surgery. Median VAS scores at 4, 12 and 24 hours were compared by suture material used and method of closure (single continuous suture or interrupted sutures). The women whose data were obtained were invited to attend focus groups of up to six people in the twelve weeks following surgery. A semi structured question guide was used, and interviews were recorded, transcribed anonymously and analysed using the constant comparative method of grounded theory. Ethical approval was not sought because formal pre-protocol work is exempt for UK ethical requirements, but formal written consent on standard forms was obtained for publishing outcomes and anonymised comments from participants.
  
  
  RESULTS
  Complete VAS data and operative details were available from 41 women. Surgery was completed using absorbable polyglactin sutures with continuous suturing (17 women) or interrupted sutures (24 women). Pain scores at 4 and 12 hours were similar; pain at 24 hours was greater in the women with interrupted sutures (median VAS 3 (range 0-8) versus 1.5 (0-8) (p = 0.0513). Analgesic needs were similar. Two focus groups (nine participants) revealed that women regarded post-operative pain as insignificant and not a topic worthy of formal research. It was apparent that the use, and especially removal of, vaginal packs was a practice associated with pain which women remembered as a significant part of their post-operative experience.
  
  
  CONCLUSIONS
  Formal pre-protocol work is informative; we found a moderate difference in our proposed outcomes, suggesting a trial was feasible but women themselves were unconvinced of the need for formal research into pain following vaginal surgery.
authors.affiliation: Leicester General Hospital, University Hospitals of Leicester NHS Trust, Gwendolen Road, Leicester, LE5 4PW UK.
authors.forename: Turlough
authors.initials: T
authors.lastname: Maguire
authors.affiliation: Leicester General Hospital, University Hospitals of Leicester NHS Trust, Gwendolen Road, Leicester, LE5 4PW UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Mayne
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Willars
authors.affiliation: Leicester General Hospital, University Hospitals of Leicester NHS Trust, Gwendolen Road, Leicester, LE5 4PW UK ; Reproductive Sciences Section, Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK.
authors.forename: Douglas
authors.initials: D
authors.lastname: Tincello
keywords: Gynaecology; Pilot; Prolapse; Qualitative; Surgery; Sutures