Hypothesis / aims of study
Vaginal hysterectomy is a common surgical procedure. It is estimated that a woman has a lifetime risk of undergoing such a procedure of at least 11% by the age of 80. Vaginal hysterectomy, as any other surgical procedure, has its own complications. Vaginal packing after vaginal hysterectomy is often used with the intention of reducing the risk of haemorrhagic complications (vaginal bleeding and/or hematoma) and infectious complications (vaginal cuff abscess formation by infection of vaginal cuff collection or hematoma). As vaginal packing may impair spontaneous bladder emptying, permanent bladder catheterisation is usually used (most often with Foley catheter) when a vaginal pack is placed. Permanent bladder catheterisation is associated with a risk of urinary infection, patient bother, delay in hospital discharge and negative impact in costs. Therefore, it is important to carefully evaluate when packing is needed. However, this is usually a routine intervention that is based on tradition. Though apparently the duration of packing has shortened in the recent years (1), there is no consensus on which is the most adequate behavior with regards to this intervention. The aim of this systematic review was to compare the complications and outcomes between the interventions of vaginal packing after vaginal hysterectomy (with or without colporraphy) against its alternative of not packing after the same surgical procedure.
Study design, materials and methods
We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement. We designed an exhaustive search in a number of databases (EMBASE, MEDLINE, and CENTRAL). We used the Population, Interventions, Comparators, Outcomes, and Study design (PICOS) framework to define the review eligibility criteria. We conducted data synthesis and subgroup analyses and assessed the certainty of evidence according to GRADE guidance. We used the findings from the reviews to formulate a clinical recommendation using an Evidence to Decision Framework.
Vaginal packing intervention: following vaginal prolapse surgery, a wide cotton gauze is packed tightly into the vaginal cavity and is usually removed on the morning of postoperative day 1. Possible benefits include reduced blood loss and decreased rates of postoperative submucosal haematoma formation.
Outcomes considered in the PICO formulation were vaginal bleeding, postoperative pain, bladder acute retention, mid-term complications (i.e. vaginal cuff collection/infection) and hospital length of stay.
A total of 88 references were identified. After abstract and full-text reviews, 4 clinical trials (involving 337 participants) were included in the review. There was no clear evidence that vaginal packing was associated with clinically meaningful reductions in adverse effects such as vaginal bleeding, hematoma formation or postoperative vaginal cuff infection. A trend towards higher incidence of vaginal hematoma as a mid-term complication was found, although differences were not statistically significant. Conversely, vaginal packing was not found to significantly affect patient bother or postoperative pain. A case-control study evaluated vaginal packing together with other interventions within an Enhanced Recovery After Surgery (ERAS) programme and concluded that this intervention might have a negative impact either on hospital stay and on costs. Overall, no clear benefit of the intervention was found on the predefined outcomes.
Most interventions were assessed by two or three Randomized Controlled Trials (RCT) with evidence quality ranging from low to moderate. The main limitation was imprecision, associated with small sample sizes, variability in outcome measures used in the different studies and low event rates.
Interpretation of results
The working group agreed that, as no clear benefit of the intervention on outcomes was found, a routine recommendation should favour minimal intervention. Therefore, the working group suggests not to routinely pack after vaginal hysterectomy (with or without colporraphy). The group also emphasizes the need to consider vaginal packing when upon the surgeon’s judgement correct haemostasis cannot be ensured during the surgical procedure.