Vaginal Packing After Laparoscopic Sacrocolpopexy

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

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 Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse; Vaginal Packing Following Laparoscopic Sacrocolpopexy
• Intervention / Treatment: Procedure: vaginal packing

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia, 30460
    • Department of Obstetrics and Gynecology, Charles University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Zdenek Rusavy, MD PhD, Medical Faculty in Pilsen, Charles University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2016
• Primary Completion (Actual): June 1, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimated): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; vaginal packing; pain and satisfaction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PACKING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO