Vaginal Packing After Laparoscopic Sacrocolpopexy

NCT02943525 | Completed

• 1 other identifier: PACKING
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Vaginal Packing Following Laparoscopic Sacrocolpopexy

Keywords

vaginal packing; pelvic organ prolapse; pain and satisfaction

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (2)

packing

EXPERIMENTAL

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

Procedure: vaginal packing

no packing

NO INTERVENTION

Patients after laparoscopic sacrocolpopexy without a vaginal packing at the end of surgery

Interventions

vaginal packing PROCEDURE

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

packing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparoscopic sacrocolpopexy without a suburethral sling
• Pelvic organ prolapse stage \> 2
• Speak and read Czech
• Can to understand the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Charles University Hospital

Pilsen, 30460, Czechia

Location

Related Publications (4)

• Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.

  PMID: 24310987 BACKGROUND

• Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.

  PMID: 26825408 BACKGROUND

• Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy - postoperative pain and satisfaction: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2026 Jan;316:114815. doi: 10.1016/j.ejogrb.2025.114815. Epub 2025 Nov 5.

  PMID: 41202691 DERIVED

• Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial. Acta Obstet Gynecol Scand. 2025 Dec;104(12):2331-2338. doi: 10.1111/aogs.70067. Epub 2025 Oct 10.

  PMID: 41070594 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Zdenek Rusavy, MD PhD

  Medical Faculty in Pilsen, Charles University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: November 14, 2016
• Primary Completion: June 1, 2022
• Study Completion: July 2, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)