CLINICAL QUESTION: Is it necessary to place a vaginal pack after vaginal hysterectomy? POPULATION OF INTEREST women undergoing vaginal hysterectomy for any reason (with or without colporrhaphy). INTERVENTION vaginal packing. COMPARISON no vaginal packing. OUTCOMES OF INTEREST i) vaginal bleeding, ii) postoperative pain, iii) acute urinary retention, iv) length of hospital stay, and v) mid-term complications.
IS THE PROBLEM A PRIORITY? Yes Research evidence and remarks from the panel Vaginal hysterectomy is a common surgical procedure estimated to be needed by at least 11% of women by age 80 years. It has specific complications. Vaginal packing is often used after surgery to reduce the number of haemorrhagic (e.g., vaginal bleeding/hematoma) and infectious (e.g., vaginal cuff abscess) complications, but this practice is not free from additional complications. Although the use and duration of packing have reduced in recent years, there is still no consensus on its indication or the most appropriate situations in which it should be used.
HOW SUBSTANTIAL ARE THE DESIRABLE ANTICIPATED EFFECTS? Moderate HOW SUBSTANTIAL ARE THE UNDESIRABLE ANTICIPATED EFFECTS? Small Research evidence and remarks from the panel See TABLE 1. SUMMARY OF FINDINGS FOR THE OUTCOMES OF INTEREST. The lack of data on important outcomes (e.g., acute urine retention or hospital stay) requires emphasis. Available data does not show differences between the intervention and its alternative. Despite the importance of knowing the impact of the procedure on hematoma risk, the studies did not report data on its impact or its associated morbidity (pain, anaemia, vaginal cuff abscess). Despite some discrepancies between author judgements, we finally agreed that the magnitude of desired effects was moderate and small for the undesired effects.
WHAT IS THE OVERALL CERTAINTY OF THE EVIDENCE OF THE EFFECTS? Moderate Research evidence and remarks from the panel The trials had small sample sizes that directly affected the precision of their effect estimates. For vaginal bleeding, the outcome measurement varied between studies, making interpretation difficult. The authors decided that the judgements regarding the certainty of the available evidence should focus on mid-term complications (specifically, on hematomas).
IS THERE MAJOR UNCERTAINTY ABOUT OR VARIABILITY IN HOW MUCH PEOPLE VALUE THE MAIN OUTCOMES? There may be uncertainty or variability Research evidence and remarks from the panel We did not identify relevant studies to inform this domain, but we anticipated some variability in the value placed by women on the different outcomes of interest.
DOES THE BALANCE BETWEEN DESIRED AND UNDESIRED EFFECTS FAVOUR THE INTERVENTION OR THE COMPARISON? The balance between desired and undesired effects from the intervention varies Research evidence and remarks from the panel We did not reach agreement about this domain: two authors considered that the balance probably favoured the alternative (not vaginal packing), two considered that the desired and undesired effects did not favour either the intervention or the alternative, and the remainder wanted more data to inform their judgement.
IS THE INTERVENTION ACCEPTABLE TO KEY STAKEHOLDERS (POPULATION, PROFESSIONALS)? Probably Research evidence and remarks from the panel One trial [Westermann 2016] measured satisfaction and inconveniencies associated with packing by visual analogue scale (range, 0–100). Women allocated to the packing group reported high satisfaction before packing removal (mean ± SD, 81.0 ± 29.0) and before discharge (90.0 ± 20.0), similar to scores in the control group. The discomfort produced by packing during the night was not important (mean VAS score 18, IQR 81, with one-third of women reporting scores of 0). Women reported more discomfort during pack removal (mean VAS score 53, IQR 57).
DOES THE COST-EFFECTIVENESS OF THE INTERVENTION FAVOUR THE INTERVENTION OR THE COMPARISON? Cost-effectiveness probably favour the intervention Research evidence and remarks from the panel We identified no directly relevant studies to inform this domain. We did obtain indirect data from a case-control study on the effectiveness of an enhanced recovery after surgery (ERAS) pathway for vaginal hysterectomy (20) that avoided using vaginal packs and indwelling catheters after surgery. Comparing 45 women to 45 matched controls revealed shorter hospitalizations (23.5 versus 42.9 hours) and lower readmission rates (6.7% versus 0.0%) with the ERAS pathway. By contrast, women in the ERAS pathway were more likely to consult for minor symptoms after discharge (15.6% vs. 0%). Despite the additional costs to implement the ERAS pathway, there was a 15% saving per patient. The certainty of the evidence is very low due to the indirectness of the data for the scope of our clinical question.