Vaginal Packing After Laparoscopic Sacrocolpopexy

Not Applicable

Active, not recruiting

• Conditions: Pelvic Organ Prolapse; Vaginal Packing Following Laparoscopic Sacrocolpopexy
• Interventions: Procedure: vaginal packing

• Registration Number: NCT02943525
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-11-14
• Primary Completion: 2022-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
packing	vaginal packing	Patients after laparoscopic sacrocolpopexy with a vaginal packing at the end of surgery

Primary Outcome Measures

Name	Time	Method
Prolapse recurrence	1 year after the surgery	Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment \>-1cm from hymen
Satisfaction with the overall postoperative course assessed using VAS	Postoperative day 5	VAS
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 VAS	The first post-operative day before extraction of the packing	Visual analog scale (VAS)
Postoperative pain assessed using the McGill Questionnaire	The first post-operative day before extraction of the packing	McGill Questionnaire

Secondary Outcome Measures

Name	Time	Method
Positive urine culture	Postoperative day 5
Number of analgesics used	From the end of the surgery until the first postoperative day
Satisfaction with surgery assessed using VAS	Postoperative day 1 before packing extraction	VAS

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Charles University Hospital; 🇨🇿 Pilsen, Czechia