Baseline patient characteristics are presented in Table 1, surgical and hospitalization data in Table 2, pain and pain medication data in Table 3, and data on psychological variables, HRQoL, and life satisfaction in Table 4. Our sample consisted of 271 women before surgery and 242 after 12 months (response rate 89%). The response rate was the same in patients with benign disease at 171 out of 190 (90%) and in patients with malignant disease at 71 out of 81 (87%). Figure 1 shows the flowchart. The internal consistency for RS-25 in our sample was excellent (Cronbach’s alpha = 0.933), for the 15-D instrument and HADS it was good (15D: 0.842; HADS: 0.863) and for the LS-4 it was acceptable ( Cronbach’s alpha = 0.712).
Gynecologic cancers (n=81) included uterine (n=50), ovarian (n=17), vulvar (n=6), cervical (n=5), and fallopian tube (n=2) and of unknown origin ( n = 1). Common benign diagnoses (n=190) were gynecologic prolapse (n=59), ovarian tumors and cysts (n=40), uterine tumors (n=31), endometriosis (n=18), and menstrual disorders, including menorrhagia, postmenopausal bleeding, and pain (n=12).
The success rate of the short-term surgical process was moderate; in the day surgery and 23 h OR model, 85% (n = 120) of patients were discharged from the PACU as scheduled on the same day or within 24 h, and 21 patients were admitted to the ward. Of the patients who underwent inpatient surgery, 129 were admitted as planned; one woman with extensive cancer surgery and major intraoperative bleeding was admitted to the intensive care unit postoperatively.
Perioperative adverse events were common but most were mild. One hundred and nine patients (40%) had at least one adverse reaction, and the most common were nausea and vomiting (n=93), dizziness (n=18), pruritus (n=7), arrhythmia (n=5), and high or low blood pressure (n=5). Other complications (n = 6) included acute coronary syndrome (n = 1), falls and fracture (n = 1), vocal cord hematoma (n = 1), hemorrhage (n = 1), anaphylaxis (n = 1), and inadvertent cutting during surgery surgery (n=1).
The one-year mortality rate was 1.8% (n=5) and the mortality rate at a mean follow-up of 36 months was 3.7% (n=10).
Primary endpoints: health-related quality of life and pain
The total questionnaire scores and the number of observations in the dichotomized questionnaire values are shown in Table 4.
The mean HRQoL score (15 D) before surgery was higher in patients with benign (0.902) and malignant disease (0.896, p= 0.640), but was lower than in the general population (0.917, p= 0.017). 12 months after surgery, the mean HRQoL score in patients with benign disease was (0.920, p= 0.090), but decreased in patients with malignancies (0.878, p= 0.154). Therefore, the mean 15D score 12 months after surgery was lower in patients with malignancy (p= 0.020) and similar to the population in patients with benign diseases (p= 0.929). The difference between the two groups (0.042) was clinically significant, as was the increase in patients with benign disease (0.018) and the decrease in patients with malignant disease (0.018). Patients with malignant diseases had more stress before surgery than patients with benign diseases, and at 12 months their scores on exercise, stress, vitality, and sexual activity were worse (Fig. 2A, B).
Exercise tolerance was moderately high in both groups, and there were no differences between groups or time points. The dichotomized questionnaire results were also similar between the groups (before surgery p= 0.920, at 12 months p= 0.783) (Table 4). Before surgery, resilience correlated weakly positively with HRQoL (Pearson’s r = 0.187) and moderately negatively with life satisfaction (r = −0.360), anxiety (r = −0.409), and depression (r = −0.422). The correlation with life satisfaction was negative due to the inverse rating on the LS-4 scale; lower values indicate higher life satisfaction. At 12 months, the correlations were similar but more pronounced: resilience had a moderate positive correlation with HRQoL (r=0.485) and a strong negative correlation with life satisfaction (r=−0.545), anxiety (r=−0.530), and depression (r= − 0.614).
Before surgery, weak to moderate correlations between HRQoL and anxiety (r = −0.263), depression (r = −0.416), and life satisfaction (r = −0.399) were observed. At 12 months postoperatively, these correlations were more pronounced; HRQoL had a strong negative correlation with anxiety (r = −0.540), depression (r = −0.624), and life satisfaction (r = −0.528).
Use of painkillers and analgesics
Data on pain and analgesic consumption are presented in Table 3.
The prevalence (p= 0.749) and intensity (p= 0.789) of preoperative pain and pain 12 months after surgery (p= 0.111 and p= 0.120) were similar in both groups. However, in women with benign conditions, pain increased both at rest (p= 0.007) and during the movement (pp= 0.259 at rest, p= 0.112 during movement). In patients with malignancies, preoperative pain (n=34) persisted 12 months after surgery in 20 (25%) patients, 10 (12%) had pain before surgery but not at follow-up, 17 (21%) had new pain pain one year after surgery and 24 (30%) patients had no pain before or 12 months after surgery. In patients with benign disease, the figures were 42 (22%) for ongoing pain, 33 (17%) for pain relief, 27 (14%) for new pain, and 65 (34%) patients for no pain before or by 12 months after Surgery (p= 0.385 between groups).
The prevalence of persistent postoperative pain (PPOP) was similar in both groups; 18 of 171 patients with benign diseases (11%) and 13 of 71 patients with malignant diseases (18%, p= 0.099) had surgery-related pain 12 months after surgery. In most patients with PPOP, pain intensity was mild; four (13%) of them had moderate or severe pain (NRS 5-7) at rest and three (10%) had moderate or severe pain during movement (NRS 5-8). The prevalence of moderate or severe pain was higher in patients without PPOP at 12 months, in 15 (20%) patients at rest (p= 0.401) and 13 (17%) patients during movement (p= 0.328).
Higher resilience scores before surgery correlated weakly positively with less pain at rest (r = −0.166) and during movement (r = −0.170) and with a lower number of different analgesics used (r = −0.194) and regular pain medication (r = −0.127). ) 12 months after surgery. Greater exercise tolerance was weakly positively correlated with better pain relief from analgesics before surgery (r=0.290) and moderately positively at 12 months after surgery (r=0.355).
Anxiety (r = 0.214) and depression (r = 0.239) before surgery were weakly positively correlated with pain one year after surgery.
Expected postoperative pain was similar in both groups; Patients with benign disease are expected to have the highest postoperative pain score of 6.5 (2.3) and patients with malignant disease 7.0 (1.9) (p= 0.099) on NRS 0-10. However, there was only a weak positive correlation between the expected and the observed maximum pain score after surgery (r = 0.252). Patients with benign and malignant diseases were willing to accept similar pain before taking analgesics when asked before surgery, 4.4 (2.0) vs. 4.2 (2.1) (p= 0.357) and 12 months after surgery 6.2 (2.0) vs. 5.7 (2.4) (p= 0.172).
Before surgery, two-thirds (n = 169) and 12 months after surgery half (n = 114) of the patients used analgesics. There was no difference in preoperative analgesic use between the two groups (p= 0.089), but 12 months after surgery, 40 patients with malignancy (56%) used analgesics more often than 74 patients with benign disease (43%) (p= 0.018).
The use of opioid analgesics was low; at 12 months, there were eight (3%) new patients using opioids, eleven (5%) had discontinued opioid use, four patients (2%) continued opioid use, and 219 (90%) patients were neither previously nor using opioids during treatment 12 months after surgery (p
The groups did not differ in the pain relief achieved with analgesics before surgery (p= 0.540), but one year after surgery, patients with malignant diseases experienced better pain relief than patients with benign diseases (p= 0.004) (Table 3).
Pain medication-related side effects before surgery (n = 18) and after 12 months (n = 22) were relatively rare. The most common side effects were gastrointestinal and included constipation, abdominal pain and diarrhea.
Other Outcome Measures
The scores for anxiety and depression are shown in Table 4. Before the operation, patients with malignant diseases were more afraid (p= 0.008). Anxiety decreased in both groups during 12 months of follow-up, and there were no differences between the two groups at 12 months (p= 0.972). Depression scores were similarly low in both groups and at both time points.
Life satisfaction was similar in both groups (Table 4), but patients with malignancies had lower life satisfaction before surgery (p= 0.011). Increased life satisfaction in patients with malignant diseases (p= 0.023), but not in patients with benign disease (p= 0.249) and was thus similar in both groups 12 months after surgery (p= 0.335).
A post-hoc sensitivity analysis showed that patients who were lost to follow-up (n=29) had similar mean preoperative questionnaire scores as other patients. There was no difference in HRQoL (p= 0.457), load capacity (p= 0.755), fear (p= 0.240), depression (p= 0.277) or life satisfaction values (p= 0.06) between respondents and non-respondents.