Pelvic Organ Prolapse, Vaginal Packing Following Laparoscopic Sacrocolpopexy
Conditions
Keywords
vaginal packing, pelvic organ prolapse, pain and satisfaction
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.
Interventions
PROCEDUREvaginal packing
Packing vagina with a Boric acid soaked gauze at the end of surgery
Sponsors
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed using VAS | The first post-operative day before extraction of the packing | Visual analog scale (VAS) |
| Satisfaction with the overall postoperative course assessed using VAS | Postoperative day 5 | VAS |
| Prolapse recurrence | 1 year after the surgery | Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment \>-1cm from hymen |
| Surgery related complications | From the surgery until 1 year after the surgery | According to the International Continence Society / International UroGynecology Association Joint Terminology and Classification Report of the complications related directly to the insertion of prostheses (meshes, implants, tapes) \& grafts in female pelvic floor surgery |
| Postoperative pain assessed using the McGill Questionnaire | The first post-operative day before extraction of the packing | McGill Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of analgesics used | From the end of the surgery until the first postoperative day | — |
| Positive urine culture | Postoperative day 5 | — |
| Satisfaction with surgery assessed using VAS | Postoperative day 1 before packing extraction | VAS |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORZdenek Rusavy, MD PhD
Medical Faculty in Pilsen, Charles University
Outcome results
None listed