Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial.
Journal
Obstetrics and gynecology
ISSN: 1873-233X
Titre abrégé: Obstet Gynecol
Pays: United States
ID NLM: 0401101
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
pubmed:
11
7
2020
medline:
13
11
2020
entrez:
11
7
2020
Statut:
ppublish
Résumé
To evaluate differences in physical function at 6 weeks after vaginal surgery among women positioned in candy cane and boot stirrups. We conducted a single-masked, randomized controlled trial of women undergoing vaginal surgery with either candy cane or boot stirrup use. The primary outcome was a change in the PROMIS (Patient-Reported Outcomes Measurement Information System) physical function short form-20a from baseline to 6 weeks after surgery. To achieve 80% power to detect a moderate Cohen effect (d=0.5), we required 64 participants in each group. From March 2018 to October 2019, 141 women were randomized, and 138 women (72 in the candy cane group and 66 in the boot stirrup group) were included in the final analysis. There were no baseline differences in participant characteristics including age, body mass index, comorbidities, or preoperative history of joint replacements. There were no between-group differences in surgery type, duration of surgery, estimated blood loss, or adverse events at 6 weeks postoperation. Participants in the candy cane group demonstrated worse physical function at 6 weeks compares with the improvement seen in those in the boot stirrup group; this was significantly different between groups (-1.9±7.9 candy cane vs 1.9±7.0 boot, P<.01). Women undergoing vaginal surgery positioned in boot stirrups have significantly better physical function at 6 weeks after surgery when compared with women positioned in candy cane stirrups. ClinicalTrials.gov, NCT03446950.
Identifiants
pubmed: 32649498
doi: 10.1097/AOG.0000000000003954
pii: 00006250-202008000-00018
doi:
Banques de données
ClinicalTrials.gov
['NCT03446950']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
333-341Commentaires et corrections
Type : CommentIn
Type : CommentIn
Références
Fleisch MC, Bremerich D, Schulte-Mattler W, Tannen A, Teichmann AT, Bader W, et al. The prevention of positioning injuries during gynecologic operations. Guideline of DGGG (S1-level, AWMF registry No. 015/077, February 2015). Geburtshilfe Frauenheilkd 2015;75:792–807.
Bohrer JC, Walters MD, Park A, Polston D, Barber MD. Pelvic nerve injury following gynecologic surgery: a prospective cohort study. Am J Obstet Gynecol 2009;201:531.e1–7.
Cardosi RJ, Cox CS, Hoffman MS. Postoperative neuropathies after major pelvic surgery. Obstet Gynecol 2002;100:240–4.
Gumus E, Kendirci M, Horasanli K, Tanriverdi O, Gidemez G, Miroglu C. Neurapraxic complications in operations performed in the lithotomy position. World J Urol 2002;20:68–71.
Litwiller JP, Wells RE Jr, Halliwill JR, Carmichael SW, Warner MA. Effect of lithotomy positions on strain of the obturator and lateral femoral cutaneous nerves. Clin Anat 2004;17:45–9.
Deveneau NE, Forbis C, Lipetskaia L, Kinman CL, Agrawal A, Herring NR, et al. The effect of lithotomy position on nerve stretch: a cadaveric study. Female Pelvic Med Reconstr Surg 2017;23:457–61.
Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J 2002;20:7–10, 27–30.
HealthMeasures.PROMIS (Patient-Reported Outcomes Measurement Information System). Available at: http://www.healthmeasures.net/explore-measurement-systems/promis. Retrieved March 26, 2020.
Hays RD, Spritzer KL, Fries JF, Krishnan E. Responsiveness and minimally important difference for the patient-reported outcomes measurement information system (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis. Ann Rheum Dis 2015;74:104–7.
Lee AC, Driban JB, Price LL, Harvey WF, Rodday AM, Wang C. Responsiveness and minimally important differences for 4 patient-reported outcomes measurement information system short forms: physical function, pain interference, depression, and anxiety in knee osteoarthritis. J Pain 2017;18:1096–110.
Schalet BD, Hays RD, Jensen SE, Beaumont JL, Fries JF, Cella D. Validity of PROMIS physical function measured in diverse clinical samples. J Clin Epidemiol 2016;73:112–8.
Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, et al. The promise of PROMIS in pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2019;25:426–9.
Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse. Am J Obstet Gynecol 2016;215:659.e1–7.
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 2005;193:103–13.
Norkin CC, White DJ. Measurement of joint motion: a guide to goniometry. 5th ed. Philadelphia, PA: FA Davis; 2016.
Quach CW, Langer MM, Chen RC, Thissen D, Usinger DS, Emerson MA, et al. Reliability and validity of PROMIS measures administered by telephone interview in a longitudinal localized prostate cancer study. Qual Life Res 2016;25:2811–23.
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003;189:98–101.
Gutman RE, Nygaard IE, Ye W, Rahn DD, Barber MD, Zyczynski HM, et al. The pelvic floor complication scale: a new instrument for reconstructive pelvic surgery. Am J Obstet Gynecol 2013;208:81.e1–9.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81.
R Core Team.R: a language and environment for statistical computing. Available at: http://www.R-project.org/. Retrieved March 26, 2020.
Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
Sze EHM. An alternate approach to using candy cane stirrups in vaginal surgery. Obstet Gynecol 2019;133:666–8.
Abdalmageed OS, Bedaiwy MA, Falcone T. Nerve injuries in gynecologic laparoscopy. J Minim Invasive Gynecol 2017;24:16–27.
Irvin W, Andersen W, Taylor P, Rice L. Minimizing the risk of neurologic injury in gynecologic surgery. Obstet Gynecol 2004;103:374–82.
Warner MA, Warner DO, Harper CM, Schroeder DR, Maxson PM. Lower extremity neuropathies associated with lithotomy positions. Anesthesiology 2000;93:938–42.