OBJECTIVE: Data concerning effect on early postoperative pain and patient satisfaction after laparoscopic sacrocolpopexy (LSC) is lacking. METHODS: Women undergoing LSC for stage >2 pelvic organ prolapse in our tertiary care urogynecology center were included in this preregistered randomized controlled trial (https://clinicaltrials.gov/study/NCT02943525). The exclusion criteria were concomitant vaginal surgery including suburethral sling or where vagina was opened during the surgery (including hysterectomy). Women were randomized to vaginal packing after LSC with a sterile gauze. The subjective perceptions of pain were measured using McGill Pain Questionnaire on day one before pack extraction. Patient satisfaction was assessed using VAS on postoperative day one and four. Women with lost or incompletely filled-in McGill pain questionnaire were excluded from the postoperative pain and satisfaction analysis. The main outcome measures included postoperative pain on day one after the surgery, patient satisfaction with the surgery and postoperative course on day one and four. RESULTS: In total, 274 women were included in the analysis, vaginal pack was inserted in 132(48 %) women. The groups did not differ in basic preoperative nor surgical characteristics. Very low and comparable values of all scores of the McGill Pain Questionnaire were observed (median VAS pain 3.0(2.0-4.2 vs. 3.0(2.0-4.0), p = 0.330). No difference in patient satisfaction on day one (8.0(6.0-9.0) vs. 8.0(6.0-8.0), p = 0.633) nor overall satisfaction on day four (9.0(8.0-10.0 vs. 9.0(9.0-9.0), p = 0.719) was observed. Deidentified data was uploaded to the Mendeley Data repository, doi: 10.17632/bnz2kcfkm2.1. CONCLUSION: Laparoscopic sacrocolpopexy is associated with low levels of pain and high patient satisfaction regardless of vaginal pack insertion. Vaginal packing does not harm the patients. CLINICAL TRIAL REGISTRATION: Registered on the 21st of October 2016, initial participant enrollment was on the 14th of November 2016, clinical trial identification number: NCT02943525, URL of the registration site: https://clinicaltrials.gov/study/NCT02943525.

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

Department of Gynecology and Obstetrics University Hospital in Pilsen Czech Republic

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Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial

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ClinicalTrials.gov
NCT02943525