Clinical trial NCT02943525: Vaginal Packing After Laparoscopic Sacrocolpopexy
Official title: Vaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaginal Packing Following Laparoscopic Sacrocolpopexy
Pelvic Organ Prolapse
Keywords: vaginal packing
pelvic organ prolapse
pain and satisfaction
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal packing is used routinely following vaginal reconstructive surgery, however, no recommendation regarding vaginal packing after laparoscopic sacrocolpopexy exists. Despite little data to support the practice, purported benefits better positioning and fixation of the mesh, improving incorporation of the mesh by its fixation and reduced blood loss. Patients often complain of discomfort associated with the packing or its removal. The aim of this randomized controlled is to compare the subjective impressions of pain and bother in women undergoing laparoscopic sacrocolpopexy treated with and without packing. The investigators also aim to assess differences in postoperative bacteriuria, urine retention and hemoglobin levels on day 5 after the surgery and surgery outcome and complications at one year after the surgery in those with and without packing.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic sacrocolpopexy without a suburethral sling
* Pelvic organ prolapse stage \> 2
* Speak and read Czech
* Can to understand the informed consent

Exclusion Criteria:

* Any other surgery than sacrocolpopexy
* Concurrent hysterectomy or opening of the vagina during the surgery.
* Vaginal, uterine, cervical or ovarian malignancy
* Clotting disorder, taking anticoagulation
* Having intraoperative blood loss greater than 500 ml

Primary outcomes:
measure: Postoperative pain assessed using VAS
timeFrame: The first post-operative day before extraction of the packing
measure: Satisfaction with the overall postoperative course assessed using VAS
timeFrame: Postoperative day 5
measure: Prolapse recurrence
timeFrame: 1 year after the surgery
measure: Surgery related complications
timeFrame: From the surgery until 1 year after the surgery
measure: Postoperative pain assessed using the McGill Questionnaire
timeFrame: The first post-operative day before extraction of the packing
Secondary outcomes:
measure: Number of analgesics used
timeFrame: From the end of the surgery until the first postoperative day
measure: Positive urine culture
timeFrame: Postoperative day 5
measure: Satisfaction with surgery assessed using VAS
timeFrame: Postoperative day 1 before packing extraction
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: Department of Obstetrics and Gynecology, Charles University Hospital
Study officials:
affiliation: Medical Faculty in Pilsen, Charles University
name: Zdenek Rusavy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
citation: Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.