Objective
To determine whether women having day-case laparoscopic supracervical hysterectomy are more or less satisfied with the length of hospital stay compared with women who stayed overnight after the procedure.
Study Design
An randomized control trial of 49 women randomized to day-case or overnight hospital stay after laparoscopic supracervical hysterectomy. Satisfaction with length of hospitalization and quality of life were compared using the Mann-Whitney U test.
Results
No group differences were found in satisfaction with length of hospital stay ( P = .13). There was a nonsignificant trend toward greater anxiety in the day-case group ( P = .06 on day 1 postoperative). Quality of life was lower in the day-case group on days 2 ( P = .02) and 4 ( P = .03), postoperatively.
Conclusion
Women having a day-case hysterectomy were discharged after median of 5 hours postoperative and were similarly satisfied as women hospitalized overnight. Quality of life, however, does appear to be compromised by day-case surgery.
Improvements in surgical technology, analgesia, and anesthetics, along with an increasing pressure on hospital resources, have led to a decline in the length of time that patients stay in hospital. Indeed, the UK government target is to increase the day-case elective surgery rate within the National Health Service to 75% by 2010, having been found to be 68% in 2001. Outpatient hysterectomy, whether as vaginal hysterectomy, laparoscopic-assisted vaginal hysterectomy, or total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy (LSH), have been a focus of interest of gynecologists for more than 2 decades and the feasibility and safety of LSH as a day-case procedure has been demonstrated. There are relatively few studies, however, that have considered women’s experiences of day-case hysterectomy. For example, Theil and Gamelin, in their small retrospective study of data obtained from patient notes, reported that the majority of women (95%) were satisfied with their day-case total laparoscopic hysterectomy and would recommend the procedure to others. Similarly, Lieng et al, in their prospective study of day-case supracervical hysterectomy found that almost all (95%) women were satisfied with the procedure and would recommend it to a friend. Whereas these studies do suggest that the women selected to day-case surgery were happy having a day-case hysterectomy, they do not examine whether this can apply to nonselected patient population needing hysterectomy. None of these studies examines whether the experiences of women having their procedure done as a day-case procedure are different from those having it done as an inpatient.
In the Oslo University Hospital Ulleval, day-case LSH has been performed, in selected cases, since 2003. A prospective case study in 2005 demonstrated safety and high patient satisfaction with this approach. Since that time, the day-case facilities have gradually been expanded, and today approximately equal numbers of LSH procedures are performed in inpatient and in day-case settings. What remains unknown, however, is whether women having a day-case LSH are less satisfied with the shorter length of stay in hospital after their operation. We report on the findings of a randomized controlled trial that set out to answer this question.
Materials and Methods
Our hypothesis was that women who had a day-case LSH would be less satisfied with the length of hospital stay when compared with women who had an overnight stay after a LSH. The null hypothesis was that there was no difference in satisfaction with length of hospital stay.
The study was performed at the Department of Gynaecology, Oslo University Hospital Ulleval, in Oslo, Norway, and was approved by the Regional Committee for Medical and Health Research Ethics South-East Region, Norway. The population from which we recruited our sample were women listed to have a hysterectomy between November 2008 and May 2009. Women were excluded if they had a previous history of cervical dysplasia, an abnormal smear test within the last 2-3 years, abnormal histology or cytology at endometrial sampling, a history of endometriosis, advanced endometriosis diagnosed intraoperatively, previous major abdominal or pelvic surgery (patients with previous cesarean section were considered as eligible), a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder, psychosis, or American Society of Anaesthesiologists score 3 and 4 patients, and inability to understand and execute oral and written Norwegian language. Women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge, or they were living or staying at a hotel more than an hour’s drive from the hospital, and if they did not have access to a telephone.
All eligible women were invited to participate in the study once a decision to have a hysterectomy was made at the outpatient clinic. They were provided with information about the study and were then contacted 1-2 weeks later to ascertain whether they were happy to take part in the study. Having agreed to participate in the study, women were randomized to either have a day-case care or inpatient care.
The randomization process was carried out using a Web-based randomization number generator ( www.randomisation.com ) and was undertaken by an external center for clinical research at the Norwegian Radium Hospital. Once women agreed to participate in the study, the clinician obtaining consent telephoned the external center to ascertain the group allocation. Women were then informed about what group they were in so that they could plan for their surgery. It was not possible to blind either the participants or the medical and nursing staff caring for the women.
Sample size
The sample size calculation was based on the primary outcome measure, satisfaction with length of hospital stay. It was measured on a 100-point visual analogue scale, a score of 100 indicating that women were completely satisfied. Although there are published data on general satisfaction with outpatient LSH, there do not appear to be any data on satisfaction with length of stay in hospital. We therefore conducted a pilot study to allow us to make a sample size calculation. In this pilot study, 11 consecutive women who had an inpatient LSH were surveyed by telephone. All women had their procedures performed during February or March 2008, approximately 1 month before they were surveyed. They were asked to imagine a scale ranging from 0-100, where 0 meant not at all satisfied and 100 meant completely satisfied with the length of time they spent in hospital after their surgery, and then asked to say where on the scale they would rate their satisfaction. The mean satisfaction score was 93.22 (SD, 11.11). Because general satisfaction after LSH is high, with the majority of women reporting total satisfaction, we believed that a 10-point difference in satisfaction with the length of stay in hospital would be clinically significant. To detect a difference of this magnitude with 80% power and 5% significance level, we needed to have 21 women per group. Based on a 20% drop-out rate, we increased this sample size to 25 per group (total of 50 women).
A total of 77 women were scheduled for LSH in the department during the enrollment period and 66 women were eligible to take part in the study. Forty-nine women agreed to take part in the study and were therefore randomized as follows: 24 to the inpatient and 25 to the day-case group. There was an equal distribution of day-case and inpatient procedures among the 17 women who did not participate in the study.
All the women were operated on by 1 of the 6 consultants from our department who routinely perform this procedure. The same operative technique and equipment was used in both groups. The treatment, including the LSH procedure itself, anesthesia, anesthesia reversal, and extubation, as well as perioperative nursing care, was the same for both groups up to the point when the women were transferred to the postoperative care unit.
The day-case group
After the initial 2-3 hours of observation in the postoperative care unit the women in the day-case group were actively encouraged by the nurses to eat, go to the bathroom, and get dressed. The surgeon informed them about how the procedure had gone. When they were ready for discharge, the nursing staff told them about the usual recovery progress and reminded them to call the department or, in case of emergency, the surgeon, if any complications arose. Then they were given their discharge and sick leave papers and analgesia with instructions for use at home. Any women not feeling well enough, or not judged by the surgeon to be well enough to leave the hospital were admitted.
The inpatient group
Women in the inpatient group were also observed for 2-3 hours in the postoperative care unit and thereafter were moved to the general women’s ward where they received routine nursing care. They were visited by the surgeon, either on the same day as the operation, or the day after, who informed them about how the procedure had gone. On the first postoperative day, women were informed about the recovery progress they could expect, given prescriptions for their pain medication and discharged home. Although all the women in the inpatient group were scheduled to stay in hospital overnight, if they wanted to leave sooner they had to make this request known to the nurse in charge, who arranged for them to have their discharge information and analgesia before they left.
All women were routinely prescribed diclofenac 50 mg × 2 per day and paracetamol 1 g × 4 per day for the first 2-3 days after the operation. Additional analgesia of tablets (10) containing 500 mg paracetamol and 30 mg codeine was also offered.
Outcomes
Capturing patient satisfaction with treatment is complex with most people tending to report high overall satisfaction with most health care treatments received. It is therefore important to ask questions about specific areas of satisfaction to reveal possible areas of dissatisfaction. Because the key difference in the treatment received by the 2 groups was the length of hospitalization after the surgery, the primary outcome of the study is defined as patients’ satisfaction with the length of hospitalization after the surgery. This was measured on a visual analogue scale from 0-100, with 0 representing not at all satisfied and 100 representing complete satisfaction.
Health-related Quality of Life (HrQoL) was measured using a generic measure, the self-completed EQ-5D (EuroQol Group, Rotterdam, The Netherlands) descriptive scale. The EQ-5D has 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which is generate a score from 0-2. A final score, EQ-5D index, ranging from −0.59 to1 is then calculated: 1 representing the best possible health. The instrument has been shown to be valid and reliable for use in a wide range of health conditions and can be administered daily. The EQ-5D is also simple and quick to complete.
Anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI).
In addition to the measures previously described, we also asked women some questions about their overall experiences of having the surgery.
To follow the progress of recovery during the first week after the operation, the EQ-5D was administered on days 0, 1, 2, 4, and 7; the STAI was administered on days 0, 1, 2, and 7 postoperatively and the satisfaction with length of hospital stay was measured on day 7 postoperatively.
Data analysis
The data were analyzed according to an intention-to-treat analysis. Group differences were investigated in the following ways: Nonparametric data (satisfaction with length of hospital stay, EQ-5D, STAI) were analyzed using the Mann-Whitney U test. Similarly, potential differences in nonparametric baseline measures (ie, age, size of uterus body mass index [BMI], previous surgery, education level) were analyzed using the Mann-Whitney U tests and χ 2 tests. P values of less than .05 were regarded as significant.
Results
Recruitment
A total of 77 women were considered to be potentially eligible for the study, but 28 of these women were not recruited (11 did not meet the inclusion criteria, 6 did not have the language skills to participate, and 5 had multiple morbidities) Of the remaining 17 nonincluded women, 6 were informed in advance by the referring gynecologist that their LSH would be performed as day-surgery and they did not want to be randomly assigned, 5 women insisted on an overnight stay for various reasons, 4 women in the absence of the study coordinator were seen by other consultants in the department who failed to invite the patients to take part in the study and finally 2 women did not want to participate in research studies in general.
Twenty-five women were recruited to the day-case group and 24 to the inpatient group. Two women in the day-case group were lost to follow-up, as was 1 woman in the inpatient group. An additional woman in the inpatient group dropped out of the study when she cancelled her operation ( Figure 1 ). This left a total of 23 women in the outpatient group and 22 in the inpatient group.
Six women in the inpatient group did not complete their treatment according to the group allocation as they requested to be discharged home on the day of their operation. In addition, 2 women in the inpatient group had prolonged hospitalization because of complications (1 required surgical repair of a bladder perforation, which was detected on the first postoperative day, and the other had a hypertensive crisis on the first postoperative day) All women in the day-case group completed the treatment according to the allocation, although 1 woman was readmitted to the hospital approximately 6 hours after she was discharged because she felt dizzy.
Baseline measures
Analysis of the baseline measures for women in both groups revealed that the groups were similar ( Table 1 ), apart from BMI, with women in the day-case group being larger (median BMI 26) than women in the inpatient group (median BMI 22) ( P = .03). Although statistically significantly different, this finding was not considered to be clinically significant.
