Vaginal Packing After Laparoscopic Sacrocolpopexy

Charles University, Czech Republic253 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

253

Conditions

Vaginal Packing Following Laparoscopic Sacrocolpopexy Pelvic Organ Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative pain assessed using VAS

Visual analog scale (VAS)

Time frame: The first post-operative day before extraction of the packing

Satisfaction with the overall postoperative course assessed using VAS

VAS

Time frame: Postoperative day 5

Prolapse recurrence

Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment \>-1cm from hymen

Time frame: 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

Time frame: From the surgery until 1 year after the surgery

Postoperative pain assessed using the McGill Questionnaire

McGill Questionnaire

Time frame: The first post-operative day before extraction of the packing

Secondary Outcomes

Number of analgesics used

Time frame: From the end of the surgery until the first postoperative day

Positive urine culture