INTRODUCTION: While the role of vaginal packing following vaginal reconstructive surgery and vaginal hysterectomy was well-explored, data regarding laparoscopic reconstructive surgery are lacking. No effect on early postoperative pain, complications, and satisfaction after laparoscopic sacrocolpopexy (LSC) was observed as presented earlier. No data concerning the effect of vaginal packing on the surgical outcome of LSC exist. Our objective was to test the hypothesis that vaginal packing after laparoscopic sacrocolpopexy is associated with a reduced risk of pelvic organ prolapse recurrence. MATERIAL AND METHODS: All women planned for laparoscopic sacrocolpopexy for pelvic organ prolapse (POPQ stage >2) in the period 11/2016-6/2022 were included in this randomized controlled trial. Those that underwent other surgery, concomitant vaginal surgery, or where the vagina was opened (e.g., during concurrent hysterectomy) were excluded. The women randomly received vaginal packing after the surgery. The primary outcome was defined as prolapse beyond the hymen, symptomatic prolapse, or retreatment in one-year follow-up. Secondary outcomes included anatomical recurrence, quality of life, and complications. CLINICAL TRIAL REGISTRATION: Registered on October 21, 2016, initial participant enrollment on November 14, 2016, clinical trial identification number: NCT02943525, URL of the registration site: https://clinicaltrials.gov/study/NCT02943525. RESULTS: Four hundred and fifty-five (89%) women completed the one-year follow-up. Vaginal pack was inserted in 214 (47%) women. The groups did not differ in most preoperative characteristics, except BMI (26.2 ± 3.4 vs. 26.9 ± 3.6, p = 0.008), preoperative POPDI (64.6 vs. 77.7, p = 0.004), operative time (103 vs. 111 min, p < 0.001), and estimated blood loss (137 vs. 157 mL, p = 0.029), which all were higher in the packing group. No differences in the primary outcome (2.8 vs. 1.7%, p = 0.527) nor any of the recorded variables including the POPQ points position, anatomical recurrence, PGI-I, ICIQ-UI, PFDI, PISQ-12 and complication rate were observed between the groups. No differences in surgical outcomes in subgroups according to concomitant surgery on the uterus (previous hysterectomy, concomitant supracervical hysterectomy, sacrohysterocolpopexy) were observed. There was no difference in the rate of complications. No mesh exposure was observed. CONCLUSIONS: Vaginal packing after laparoscopic sacrocolpopexy is not associated with improved surgical outcomes expressed in anatomic recurrence, composite surgical failure, or quality of life. In light of Enhanced Recovery After Surgery recommendations, routine vaginal packing after laparoscopic sacrocolpopexy cannot be recommended.

Department of Gynecology and Obstetrics Faculty of Medicine in Pilsen Charles University Pilsen Czech Republic

Department of Gynecology and Obstetrics University Hospital in Pilsen Charles University Pilsen Czech Republic

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NCT02943525