Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| packing | Experimental | Patients after laparoscopic sacrocolpopexy with a vaginal packing at the end of surgery |
|
| no packing | No Intervention | Patients after laparoscopic sacrocolpopexy without a vaginal packing at the end of surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal packing | Procedure | Packing vagina with a Boric acid soaked gauze at the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain assessed using VAS | Visual analog scale (VAS) | The first post-operative day before extraction of the packing |
| Satisfaction with the overall postoperative course assessed using VAS | VAS | Postoperative day 5 |
| Prolapse recurrence | Pelvic Organ Prolapse Quantification System (POP-Q) classification - the most descending compartment >-1cm from hymen | 1 year after the surgery |
| 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 |
| Postoperative pain assessed using the McGill Questionnaire | McGill Questionnaire | The first post-operative day before extraction of the packing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of analgesics used | From the end of the surgery until the first postoperative day | |
| Positive urine culture | Postoperative day 5 | |
| Satisfaction with surgery assessed using VAS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zdenek Rusavy, MD PhD | Medical Faculty in Pilsen, Charles University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Charles University Hospital | Pilsen | 30460 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24310987 | Background | 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. | |
| 26825408 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D010146 | Pain |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
VAS |
| Postoperative day 1 before packing extraction |
| 41202691 | Derived | Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy - postoperative pain and satisfaction: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2026 Jan;316:114815. doi: 10.1016/j.ejogrb.2025.114815. Epub 2025 Nov 5. |
| 41070594 | Derived | Rusavy Z, Marinic Veverkova A, Smazinka M, Kalis V. Vaginal packing after laparoscopic sacrocolpopexy and surgical outcome after one year: A randomized controlled trial. Acta Obstet Gynecol Scand. 2025 Dec;104(12):2331-2338. doi: 10.1111/aogs.70067. Epub 2025 Oct 10. |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |