Vaginal Packing After Laparoscopic Sacrocolpopexy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Packing Following Laparoscopic Sacrocolpopexy Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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packing

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

Group Type EXPERIMENTAL

vaginal packing

Intervention Type PROCEDURE

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

no packing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vaginal packing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No