Methods
This was a single-centre double-blind parallel randomized
controlled trial performed at a tertiary care teaching hospital
(University Hospital, Faculty of Medicine in Pilsen, Charles University)
in Pilsen, Czechia. The recruitment occurred in the study period
November 2016 – June 2022. Approval was obtained from the Ethics
committee of the Faculty of Medicine in Pilsen, Charles University
(approval number 411/2016, approved October 6, 2016) prior to
study commencement. The trial was registered in clinicaltrials.gov
registry ( NCT02943525, registered October 21, 2016). All women
with pelvic organ prolapse stage > 2 according to POPQ
classification admitted for LSC without concomitant hysterectomy or
with
supracervical hysterectomy were considered eligible for enrolment.
Women undergoing any other surgery, concomitant vaginal surgery
including suburethral sling or where vagina was opened during the
surgery (e.g. during concurrent hysterectomy), were excluded from the
study. Other exclusion criteria included clotting disorders,
anticoagulant use as well as vaginal, uterine or ovarian malignancy. In
addition, women with lost or incompletely filled-in pain
questionnaire were excluded from this postoperative pain and
satisfaction analysis. The primary outcome of the study was
postoperative pain on day one after the surgery. The secondary outcomes
were patient satisfaction with surgery on postoperative day 1 and
satisfaction with the overall postoperative course, bacteriuria and
anaemia on postoperative day 4.
The patients were enrolled either in consultation office or after
admission to the hospital after signing the informed consent. Prior to
the surgery the women underwent a complex urogynecologic examination
including POP-Q staging, quality of life assessment and pelvic floor
ultrasound. The surgical technique remained constant for the study
period as described previously in detail 9, 10and was performed by four certified urogynaecologists proficient in the
LSC surgical technique. Upon completion of the procedure, a surgical
nurse opened an opaque sealed envelope to reveal each subject’s
allocated study arm (1:1 randomization). This timing was chosen to
reduce any bias or change in the surgical procedure as a result of the
subject’s randomization 4. Patients in the
intervention arm had a 100% cotton, fine mesh gauze, 7x150cm, soaked
with 3% boric acid solution tightly packed into their vagina. The
patients and the caring staff were both blinded regarding the allocated
group until assessment of the primary outcome on day 1 after the surgery
to avoid any bias. The postoperative pain was managed according to a
standard clinical protocol equally regardless of allocated group. It was
a standard to provide continuous morphine 0.5 – 2 mg per hour on the
day of the surgery and then paracetamol 1g or metamizole 2.5g for
breakthrough pain. The day after the surgery before potential extraction
of the pack, the women were asked to complete the validated Czech
version of the short form McGilll Pain Questionnaire 11. The short form of the McGill Pain
Questionnaire provides five scores: sensory, affective, and total scores
from the descriptors, and overall intensity scores from the Present Pain
Intensity and Visual Analog Scale 12. Patient
satisfaction was evaluated on a scale from 0 for “not satisfied” to 10
for “very satisfied” on the postoperative day 1 for overall
satisfaction after surgery and on postoperative day 4 for overall
satisfaction with the postoperative course. VAS was measured in mm and
recorded in cm after rounding. Midstream urine sample was collected for
culture and blood was taken for haemoglobin level assessment on
postoperative day 4.
An independent statistician provided statistical analysis and
advice throughout the study. The power calculation for the main outcome
measure was adopted from a study by Thiagamoorthy et al., which
calculated that 86 patients in each group were required to reject the
null hypothesis of no difference between the groups with alpha 0.05 and
90 % power 5. The power calculation for
patient satisfaction assessment using VAS was adopted from the study by
Westerman et al.; 37 participants per group were needed to detect a mean
difference of 14 mm on a 100-mm VAS with 90% power and an alpha of
0.05 4. More women were enrolled in the groups
for assessment of surgical outcome and complications in one-year
follow-up in the second part of this randomized controlled trial. All
data were stored and collected using a clinical database and evaluated
by the following statistical analyses depending on distribution of
normality: Wilcoxon pair test, χ2 test, Kruskal-Wallis test, Fisher
exact test, Median Two Sample test. P-value under 0.05 was
considered statistically significant.