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Completed

NCT Number: NCT02943525

Vaginal Packing After Laparoscopic Sacrocolpopexy

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.

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Key information

Conditions

Vaginal Packing Following Laparoscopic Sacrocolpopexy Behavior Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Personal Satisfaction Prolapse Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Charles University Hospital

Pilsen, 30460, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal Packing

Procedure

Packing vagina with a Boric acid soaked gauze at the end of surgery

Primary outcomes

  1. Postoperative pain assessed using VAS

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

    Visual analog scale (VAS)

  2. Satisfaction with the overall postoperative course assessed using VAS

    Time frame: Postoperative day 5

    VAS

  3. Prolapse recurrence

    Time frame: 1 year after the surgery

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

  4. Surgery related complications

    Time frame: 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

  5. Postoperative pain assessed using the McGill Questionnaire

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

    McGill Questionnaire

Secondary outcomes

  1. Number of analgesics used

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

  2. Positive urine culture

    Time frame: Postoperative day 5

  3. Satisfaction with surgery assessed using VAS

    Time frame: Postoperative day 1 before packing extraction

    VAS

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Oct 24, 2016
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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