To pack or not to pack after laparoscopic sacrocolpopexy – a randomized controlled trial

Background: No data concerning effect of vaginal packing on surgical outcome of laparoscopic sacrocolpopexy (LSC) exist.
Objective: To test the hypothesis that vaginal packing after LSC is associated with reduced risk of pelvic organ prolapse recurrence.
Study design: This is a double-blind randomized controlled trial to investigate the effect of vaginal packing after LSC on surgical outcome in one-year follow-up. All women planned for LSC without suburethral sling surgery for pelvic organ prolapse stage > 2 according to POPQ were included. Women that finally underwent any other surgery, concomitant vaginal surgery or their vagina was opened during the surgery (e.g. concurrent hysterectomy) were excluded. Of the 512 randomized women enrolled in the period 11/2016 – 6/2022, 455 (89%) women completed the one-year follow-up and were included in the analysis. Vaginal pack was inserted in 214 (47%) women. All women were preoperatively examined including POPQ and completed ICIQ-UI, PFDI and PISQ-12 questionnaires. They were randomized at the end of the surgery using envelope method. The surgical technique remained constant for the study period and was performed by four surgeons. One year after the surgery, the patients were reassessed including the POPQ, PGI-I and quality of life questionnaires. The primary outcome was composite surgical failure defined as a prolapse beyond hymen or symptomatic prolapse or retreatment after one year. Secondary outcomes included anatomical recurrence, quality of life and any late surgery-related complications. The data was analyzed using Wilcoxon two sample test, Median test, χ2 test and Fisher´s exact test. P value <.05 was considered statistically significant.
Results: The groups did not differ in most preoperative characteristics, except BMI, preoperative PFDI, because of POPDI, operative time and estimated blood loss, which all were higher in the packing group. The numbers of concomitant surgery on the uterus were comparable within the groups; 137 had prior hysterectomy, 249 underwent supracervical hysterectomy and 69 had sacrohysteropexy. No differences in the primary outcome nor any of the recorded variables including the POPQ points position, anatomical recurrence, patient global impression of improvement, quality of life questionnaires and complications were observed between the groups in one-year follow-up. Furthermore, no differences in surgical outcomes were observed even in subgroups according to concomitant surgery on the uterus. There was no difference in the rate of complications. No mesh exposure was observed.
Conclusion: Vaginal packing after LSC is not associated with improved surgical outcome expressed in anatomic recurrence, composite surgical failure or quality of life. In the light of Enhanced Recovery After Surgery recommendations, routine vaginal packing after laparoscopic sacrocolpopexy cannot not be justified.