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Vaginal Packing After Laparoscopic Sacrocolpopexy

Primary Purpose

Vaginal Packing Following Laparoscopic Sacrocolpopexy, Pelvic Organ Prolapse

Status

Active

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

vaginal packing

About this trial

This is an interventional treatment trial for Vaginal Packing Following Laparoscopic Sacrocolpopexy focused on measuring vaginal packing, pelvic organ prolapse, pain and satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Obstetrics and Gynecology, Charles University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

packing

no packing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain assessed using VAS

Visual analog scale (VAS)

Satisfaction with the overall postoperative course assessed using VAS

VAS

Prolapse recurrence

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

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

Postoperative pain assessed using the McGill Questionnaire

McGill Questionnaire

Secondary Outcome Measures

Number of analgesics used

Positive urine culture

Satisfaction with surgery assessed using VAS

VAS

Full Information

NCT ID

NCT02943525

First Posted

October 21, 2016

Last Updated

August 29, 2023

Sponsor

Charles University, Czech Republic

1. Study Identification

Unique Protocol Identification Number

NCT02943525

Brief Title

Vaginal Packing After Laparoscopic Sacrocolpopexy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 14, 2016 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charles University, Czech Republic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Packing Following Laparoscopic Sacrocolpopexy, Pelvic Organ Prolapse

Keywords

vaginal packing, pelvic organ prolapse, pain and satisfaction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

253 (Actual)

8. Arms, Groups, and Interventions

Arm Title

packing

Arm Type

Experimental

Arm Description

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

Arm Title

no packing

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

vaginal packing

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pain assessed using VAS

Description

Visual analog scale (VAS)

Time Frame

The first post-operative day before extraction of the packing

Title

Satisfaction with the overall postoperative course assessed using VAS

Description

VAS

Time Frame

Postoperative day 5

Title

Prolapse recurrence

Description

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

Time Frame

1 year after the surgery

Title

Surgery related complications

Description

Time Frame

From the surgery until 1 year after the surgery

Title

Postoperative pain assessed using the McGill Questionnaire

Description

McGill Questionnaire

Time Frame

The first post-operative day before extraction of the packing

Secondary Outcome Measure Information:

Title

Number of analgesics used

Time Frame

From the end of the surgery until the first postoperative day

Title

Positive urine culture

Time Frame

Postoperative day 5

Title

Satisfaction with surgery assessed using VAS

Description

VAS

Time Frame

Postoperative day 1 before packing extraction

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zdenek Rusavy, MD PhD

Organizational Affiliation

Medical Faculty in Pilsen, Charles University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynecology, Charles University Hospital

City

Pilsen

ZIP/Postal Code

30460

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24310987

Citation

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.

Results Reference

background

PubMed Identifier

26825408

Citation

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.

Results Reference

background

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Vaginal Packing After Laparoscopic Sacrocolpopexy

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