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Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial
Ankita Gupta1, Kate Meriwether, Molly Tuller
1Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics & Gynecology, and the Department of Obstetrics & Gynecology, University of Louisville School of Medicine, and the Department of Bioinformatics & Biostatistics, School of Public Health and Information Sciences, University of Louisville, Louisville, Kentucky; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, University of New Mexico, Albuquerque, New Mexico; and the Department of Obstetrics & Gynecology, Wayne State University School of Medicine, Detroit, Michigan.
Objective:
To evaluate differences in physical function at 6 weeks after vaginal surgery among women positioned in candy cane and boot stirrups.
Methods:
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.
Results:
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).
Conclusion:
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.
Clinical Trial Registration:
ClinicalTrials.gov, NCT03446950.
