Vaginal Packing After Laparoscopic Sacrocolpopexy

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02943525
• Other study ID #: PACKING
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2016
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 253
• Est. completion date: December 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Packing Following Laparoscopic Sacrocolpopexy

Intervention

Procedure:
• vaginal packing
Packing vagina with a Boric acid soaked gauze at the end of surgery

Locations

Country	Name	City	State
Czechia	Department of Obstetrics and Gynecology, Charles University Hospital	Pilsen

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain assessed using VAS	Visual analog scale (VAS)	The first post-operative day before extraction of the packing
Primary	Satisfaction with the overall postoperative course assessed using VAS	VAS	Postoperative day 5
Primary	Prolapse recurrence	Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment >-1cm from hymen	1 year after the surgery
Primary	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	From the surgery until 1 year after the surgery
Primary	Postoperative pain assessed using the McGill Questionnaire	McGill Questionnaire	The first post-operative day before extraction of the packing
Secondary	Number of analgesics used		From the end of the surgery until the first postoperative day
Secondary	Positive urine culture		Postoperative day 5
Secondary	Satisfaction with surgery assessed using VAS	VAS	Postoperative day 1 before packing extraction