Vaginal Packing After Laparoscopic Sacrocolpopexy

Charles University, Czech Republic

Status: Active, not recruiting

Conditions: Vaginal Packing Following Laparoscopic Sacrocolpopexy; Pelvic Organ Prolapse

Treatments: Procedure: vaginal packing

Study type: Interventional

Funder types: Other

Identifiers

NCT02943525

PACKING

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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253 participants in 2 patient groups

packing

Experimental group

Description:

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

Treatment:

Procedure: vaginal packing

no packing

No Intervention group

Description:

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