Vaginal Packing After Laparoscopic Sacrocolpopexy

Study Overview
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Brief Summary
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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.

Official Title
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Vaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up

Conditions
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Vaginal Packing Following Laparoscopic Sacrocolpopexy, Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: vaginal packing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: packing<br>Patients after laparoscopic sacrocolpopexy with a vaginal packing at the end of surgery | Procedure: vaginal packing<br>* Packing vagina with a Boric acid soaked gauze at the end of surgery<br>|
| No Intervention: no packing<br>Patients after laparoscopic sacrocolpopexy without a vaginal packing at the end of surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed using VAS | Visual analog scale (VAS) | The first post-operative day before extraction of the packing | 
| Satisfaction with the overall postoperative course assessed using VAS | VAS | Postoperative day 5 | 
| Prolapse recurrence | Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment >-1cm from hymen | 1 year after the surgery | 
| Surgery related complications | 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 | From the surgery until 1 year after the surgery | 
| Postoperative pain assessed using the McGill Questionnaire | McGill Questionnaire | The first post-operative day before extraction of the packing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | VAS | Postoperative day 1 before packing extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal packing, pelvic organ prolapse, pain and satisfaction