Completed

Assessment of Vaginal Packing Impact on Pain, Satisfaction, and Surgical Outcomes After Laparoscopic Sacrocolpopexy

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Study Aim

This study aims to assess the impact of vaginal packing on pain, satisfaction, and surgical outcomes after laparoscopic sacrocolpopexy, focusing on postoperative pain, prolapse recurrence, satisfaction with the postoperative course, and surgery-related complications.

What is being tested

vaginal packing

Procedure
Who is being recruted

Behavior+6

+ Neurologic Manifestations

+ Pain

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2016
See protocol details

Summary

Principal SponsorCharles University, Czech Republic
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 14, 2016

Actual date on which the first participant was enrolled.

This study focuses on the use of vaginal packing after a specific type of surgery called laparoscopic sacrocolpopexy, a procedure used to correct pelvic organ prolapse. The study aims to understand if vaginal packing after this surgery provides any benefits, such as better positioning and fixation of the mesh used in the surgery, or if it causes discomfort to patients. The study involves women undergoing this surgery and aims to improve our understanding of the best care practices for this condition. During the study, participants will be divided into two groups - one with vaginal packing after the surgery and one without. The study will measure postoperative pain using two methods: the McGill Questionnaire and a Visual Analog Scale (VAS). It will also assess patient satisfaction with the overall postoperative course, any surgery-related complications, and prolapse recurrence. The study will also look at differences in postoperative bacteriuria, urine retention, and hemoglobin levels on day 5 after the surgery between the two groups.

Official TitleVaginal Packing After Laparoscopic Sacrocolpopexy; Patient Pain and Satisfaction in Short Follow-up and Surgery Outcome and Complications in One Year Follow-up
Principal SponsorCharles University, Czech Republic
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

253 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorNeurologic ManifestationsPainPersonal SatisfactionProlapseSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalPelvic Organ Prolapse

Criteria

4 inclusion criteria required to participate
Laparoscopic sacrocolpopexy without a suburethral sling

Pelvic organ prolapse stage > 2

Speak and read Czech

Can to understand the informed consent

5 exclusion criteria prevent from participating
Any other surgery than sacrocolpopexy

Vaginal, uterine, cervical or ovarian malignancy

Clotting disorder, taking anticoagulation

Having intraoperative blood loss greater than 500 ml

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Obstetrics and Gynecology, Charles University Hospital

Pilsen, CzechiaOpen Department of Obstetrics and Gynecology, Charles University Hospital in Google Maps
CompletedOne Study Center