To pack or not to pack? A randomized trial of vaginal packing after vaginal reconstructive surgery
Abstract
OBJECTIVE: Placement of vaginal packing after pelvic reconstructive surgery is common; however, little evidence exists to support the practice. Furthermore, patients have reported discomfort from the packs. We describe pain and satisfaction in women treated with and without vaginal packing. METHODS: This institutional review board-approved randomized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs. The primary outcome was visual analog scales (VASs) for pain on postoperative day 1. Allocation to "packing" ("P") or "no-packing" ("NP") arms occurred intraoperatively at the end of surgery. Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal. Visual analog scale scores for pain, satisfaction, and bother attributable to packing were recorded before discharge. All packing and perineal pads were weighed to calculate a "postoperative vaginal blood loss." Perioperative data were collected from the hospital record. Our sample size estimation required 74 subjects. RESULTS: Ninety-three women were enrolled. After exclusions, 77 were randomized (P, 37; NP, 40). No differences were found in surgical information, hemoglobin levels, or narcotic use between groups. However, "postoperative vaginal blood loss" was greater in packed subjects (P < 0.001). Visual analog scale scores for pain before removal of packing (P, 41.6 vs NP, 46.3; P = 0.43] and before discharge (P, 35.0 vs NP, 40.0; P = 0.43] were not significantly different between treatment arms. Likewise, VAS scores for satisfaction before removal of packing (P, 81.0 vs NP, 90.0; P = 0.08] and before discharge (P, 90.0 vs NP, 90.5; P = 0.60] were not significantly different. Packed patients noted lower nursing verbal pain scores (P = 0.04) and used less ketorolac (P = 0.01). Bother from packing was low overall. CONCLUSIONS: Although there was no difference based on VAS, women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women. Vaginal packing may provide benefit and can remain part of the surgical practice.
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Two trials with a total of 266 women evaluated POP surgery with or without vaginal packing.
“POP surgery with or without vaginal packing: two trials with a total of 266 women (Thiagamoorthy 2014; Westermann 2016).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
It is uncertain whether there is a clinically relevant difference in hospital readmission rates for women given or without vaginal packing.
“Based on data from a single trial (Westermann 2016), we are uncertain whether there is a clinically relevant difference in hospital readmission rates for women given or without vaginal packing (OR 1.08, 95% CI 0.07 to 16.67; 1 study, 77 women; very low‐certainty evidence; Analysis 9.1).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
It is uncertain if there is a clinically relevant difference in rates of blood transfusion in women given a vaginal pack versus no vaginal pack.
“Based on data from a single trial (Westermann 2016), we are uncertain if there is a clinically relevant difference in rates of blood transfusion in women given a vaginal pack versus no vaginal pack (OR 2.85, 95% CI 0.11 to 72.12; 1 study, 77 women; very low‐certainty evidence; Analysis 9.2).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the randomisation method was computer randomisation.
“Randomisation method: computer randomisation (computer‐generated randomisation table n‐Query Advisor)”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of selection bias from allocation concealment was low.
“Allocation concealment (selection bias) Low risk Sealed opaque envelope only opened after surgery was finished and when ready to pack the vagina, so not to affect surgical decision‐making.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the study was single blinded.
“Blinding: single blinded as women not informed of packing status until the first VAS score was completed.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of selection bias from random sequence generation was unclear.
“Random sequence generation (selection bias) Unclear risk Women assigned randomly via sequential envelopes. Study mentions randomisation table was generated, but not how and where the envelope was packaged”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of reporting bias from selective reporting was low.
“Selective reporting (reporting bias) Low risk Same outcome measures reported as stated in trial registry”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of detection bias from blinding of outcome assessment was high.
“Blinding of outcome assessment (detection bias) All outcomes High risk Unable to blind patients as they would know whether they have a vaginal pack or not and the primary outcome was a patient‐reported VAS pain score. Even if the first VAS score was given prior to the patient knowing whether they had a pack or not, packs can be felt, so bias is present and data collection post the first VAS would”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of other bias was low.
“Other bias Low risk No conflicts of interest”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, a power calculation was performed.
“Power calculation: 90% power to detect mean difference of 14mm on 100mm VAS pain score with p set to 0.05”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of performance bias from blinding of participants and personnel was high.
“Blinding of participants and personnel (performance bias) All outcomes High risk Surgeon unable to be blinded to intervention”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
In Westermann 2016, the risk of attrition bias from incomplete outcome data was low.
“Incomplete outcome data (attrition bias) All outcomes Low risk 77/77 women all followed up”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Westermann 2016
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- Authors
- Westermann, L. B., Crisp, C. C., Oakley, S. H., Mazloomdoost, D., Kleeman, S. D., Benbouajili, J. M., Ghodsi, V., & Pauls, R. N.
- Affiliations
- Good Samaritan Hospital (US)
- Venue
- Female Pelvic Medicine & Reconstructive Surgery
- Published
- 2016-03
- Volume
- 22
- Issue
- 2
- Pages
- 111-117
- ISSN
- 2151-8378 (ISSN-L)
- OpenAlex
- W2417468503
- Cited by
- 25
- References
- 12
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 3 · 2021: 1 · 2020: 4 · 2019: 3 · 2018: 4 · 2017: 2
- FWCI
- 3.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Urogynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- vaginal packing, vaginal reconstruction, pelvic reconstruction, vaginal hysterectomy, pelvic organ prolapse surgery, postoperative pain, patient satisfaction
- MeSH terms
- Female, Humans, Hysterectomy, Vaginal, Middle Aged, Vagina, Surgical Sponges, Single-Blind Method, Patient Satisfaction, Postoperative Hemorrhage, Pelvic Organ Prolapse
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