Assessment of Vaginal Packing Impact on Pain, Satisfaction, and Surgical Outcomes After Laparoscopic Sacrocolpopexy
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.
vaginal packing
Behavior+6
+ Neurologic Manifestations
+ Pain
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.253 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Department of Obstetrics and Gynecology, Charles University Hospital
Pilsen, CzechiaOpen Department of Obstetrics and Gynecology, Charles University Hospital in Google Maps