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Activity restriction recommendations and outcomes after reconstructive pelvic surgery: a randomized controlled trial |
Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K |
Obstetrics and Gynecology 2017 Apr;129(4):608-614 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To assess the relationship between prescribed postoperative activity recommendations (liberal compared with restricted) after reconstructive prolapse surgery and patient satisfaction and pelvic floor symptoms. METHODS: In our multicenter, randomized, doubleblind clinical trial, women undergoing reconstructive prolapse surgery were randomized to liberal compared with restricted postoperative activity recommendations. Liberal recommendations instructed women to resume postoperative activity at the woman's own pace with no restrictions on lifting or high-impact activities. Conversely, restricted recommendations instructed women to avoid heavy lifting or strenuous exercise for 3 months. The primary outcome, patient satisfaction, was assessed on a 5-point Likert scale at 3 months postoperatively with the question, "How satisfied are you with the result of your prolapse surgery?" Secondary outcomes included anatomic outcomes and pelvic floor symptoms. RESULTS: From September 2014 to December 2015, 130 women were screened and 108 were randomized. Ultimately, 95 were allocated to study intervention (n545 liberal, n550 restricted) and completed the primary outcome. Baseline characteristics (including pelvic organ prolapse quantification stage and demographics) and surgical intervention did not differ between groups. Most women underwent a minimally invasive sacrocolpopexy (58) followed by vaginal suspension (27) or vaginal closure procedures (nine). Rates of satisfaction were similarly high in the liberal and restricted recommendations groups (98% compared with 94%, odds ratio 0.36 (0.036 to 3.55), p = 0.619). Anatomic outcomes did not differ between groups; however, fewer pelvic floor symptoms were reported in the liberal group. CONCLUSION: Satisfaction was equally high 3 months after prolapse surgery in women who were instructed to liberally resume activities compared with those instructed to restrict postoperative activities. Women who liberally resumed their activities reported fewer prolapse and urinary symptoms and had similar short-term anatomic outcomes suggesting that allowing women to resume their normal activities postoperatively may result in improved pelvic floor outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT02138487.
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