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Short stay laparoscopic hysterectomy: An evaluation of feasibility and patient satisfaction

Background Short-stay total laparoscopic hysterectomy (TLH) could lead to reduced hospital costs and decrease complications associated with hospitalisation such as hospital acquired-infection and venous thromboembolism. Objective To evaluate the feasibility, safety and patient satisfaction of a novel short ‘less than 23-hour’ stay TLH protocol. Material and Methods Prospective cohort study, at Birmingham Women’s Hospital, United Kingdom including eligible women undergoing TLH for benign indications or early stage cervical/endometrial cancer. Main outcome measures Feasibility of discharge within 23-hours following TLH. Surgical complications and readmission rates were collected within 30-days of hysterectomy and patient’s satisfaction was assessed at 6-weeks. Results Of the 128 eligible women, 104/128 women (81%) were discharged within 23-hours of admission, of which 62/104 or 60% (48.4% of the whole cohort) were discharged on the same day. Adenomyosis/fibroids, and previous caesarean sections were associated with a greater likelihood of stay beyond 23-hours (P<0.05). The overall complications rate was 13/128 (10%) with two grade-3 Clavien-Dindo intraoperative complications; one serosal bowel injury oversewn and one ureteric injury requiring reimplantation. The readmissions rate was 5/128 (4%). 94% of patients were ‘happy’ or ‘very happy’ with the pathway, although satisfaction was higher in short-stay patients (RR 1.2; 95% CI 0.95–1.94). Conclusion Hospital discharge within 23-hours of TLH appears to be safe, feasible and acceptable to patients where a standardised, multidisciplinary care protocol is used. What is new? Our study is the first prospective case series in the UK reporting the safety and acceptability for performing laparoscopic hysterectomy as a 23-hour day case procedure.


Introduction
The proportion of laparoscopic hysterectomies in the United Kingdom, Europe and the United States of America have increased significantly compared to abdominal or vaginal approaches (Perino et al., 1999;Lonky et al., 2017;Madhvani et al., 2019;Meulen et al., 2018).
These endoscopic techniques combined with advances in technology and training have enabled shorter lengths of stay after gynaecological surgery with 42-97% success rate of 'outpatient' ('daycase' or 'ambulatory') laparoscopic hysterectomies performed in the US, and Europe (Moawad et al., 2017).The application of 23-hour discharge following laparoscopic hysterectomy in the UK is at present sporadic and infrequent, with no observational series published in the UK to date recording the safety and acceptability for performing laparoscopic hysterectomy as a 23-hour day case procedure. Although short-stay hysterectomy is associated with both clinical and economic benefits (Warren et al., 2009), the practice is not established. This may reflect a lack familiarity with early discharge.
In 2019, a guideline from the Association of Anaesthetists and the British Association of Day Surgery (Bailey et al., 2019) was published recommending a multidisciplinary approach between surgeons and the anaesthetic department, with agreed protocols for patient assessment to facilitate short postoperative stay. We designed a multidisciplinary enhanced recovery protocol and introduced a short stay hysterectomy pathway as part of a quality improvement project. The aim of our study was to evaluate if 23-hour discharge was feasible after total laparoscopic hysterectomy (TLH) in a unit unfamiliar with this concept, and to identify factors predictive for success and to evaluate patient satisfaction.

Materials and Methods
We performed a prospective, observational cohort study. All laparoscopic hysterectomies were undertaken at the Birmingham Women's and Children's Hospital (BWCH), a UK University Teaching Hospital. Data were prospectively collected over a two-year period from January 2019 and to December 2020 for women undergoing total laparoscopic hysterectomy (TLH) for benign or malignant disease.

Pre-operative interventions
Patients were eligible for short-stay hysterectomy if they were between 18 -60 years of age with an American Society of Anesthesiologists physical status score (ASA) I-II, a body mass index (BMI) of ≤ 35 and the surgical team did not anticipate any surgical complications. To meet the inclusion criteria, women needed to reside within one hours travel from the BWCH, and could arrange continuous home support for 24-hours. The criteria for exclusion were patients above the age of 60, a history of cardio-pulmonary compromise, renal disease, or sleep apnoea. Patients were provided with a diary that they were asked to complete in order to follow their journey, and provided with written information of what to expect after the procedure. The diary set up goals for recovery including: mobilising, diet, passing urine, satisfactory wound healing, pain control, and general health. Patients were made aware that completion of this diary was optional. Eligible patients were provided with a written information leaflet.
Women were advised to arrange appropriate post-operative support at home, and were instructed to eat up to 02.30 on the day of surgery and encouraged to drink water until two hours before surgery. All women were admitted on the day of surgery and given anti-embolic stockings. Low molecular weight heparin was used according to standard gynaecology venous thromboembolism (VTE) protocol based on risk assessment for VTE. All women were given a single dose of intravenous antibiotics immediately before the start of surgery.

Intra-operative
Induction and maintenance anaesthetic regimens were according to the anaesthetist's preference. Routine use of patient controlled anaesthesia (PCAs) was avoided and long acting narcotics were used sparingly to minimise somnolence and induction of paralytic ileus.
Intraoperatively local anaesthetic either at port sites and/or as laparoscopic transversus abdominis plane blocks (LTAPs) were used to allow early mobilisation. The technical steps for conducting a TLH were left to the discretion of the operating surgeon. The routine use of drains was avoided. Vaginal cuff was closed laparoscopically in all cases using continuous barbed suture.

Post-operative
Nursing staff were provided with specific postoperative care protocols. Additionally, an escalation criterion to medical staff was provided. Women could drink normally and offered a light diet when hungry. Non-opioid, oral analgesics and routine anti-emetics were provided, and the urinary catheter was removed within 4-6 hours of the procedure. Patients could go home if they were able to void spontaneously and empty the bladder satisfactorily following catheter removal.
On discharge, nursing staff provided an emergency contact number for the hospital and a scheduled nurse-led follow-up phone call was arranged within 24-48 hours of discharge (Table  I). Women were asked to complete a questionnaire at 6 weeks after the surgery ( Figure 1) to assess the patient experience, compliance and satisfaction with the short-stay pathway.

Theory/calculation
The primary outcome was feasibility of the shortstay TLH pathway. Secondary outcomes included the proportion of women achieving same day 'outpatient' discharge, rates of intra-operative and post-operative complications defined according to the Clavien-Dindo system (Dindo et al., 2004), representation, and readmission. In addition, data regarding patient's satisfaction was collected at six weeks postoperatively.

Statistical analysis
Descriptive analyses specifying the mean (m) for each quantitative variable and the percentages (%) and the size (n) are defined. Analyses were conducted using the graphpad statistics tool. A p = < 0.05  was considered significant. Women proactively converted to a laparotomy prior to commencing any surgical steps of a LH were excluded from analysis, but the numbers (%) presented.

Baseline characteristics
Two hundred-eighty-nine patient's laparoscopic hysterectomies were performed of which, 128 (45%) women were placed upon the short-stay hysterectomy pathway and were included in the final analysis ( Figure 2). Of the remaining 161 patients, 53/161 (33%) were not included due to social, medical or surgical ineligibility, and 108/161 patients (67%) were eligible, but were not enrolled due to a lack of familiarity with the newly implemented pathway. These 108 patients had a mean length of stay of 1.47, median of 1 (1-3) days.
The average age and BMI of the study population were 47.4 years and 28 kg/m 2, respectively. The most common reasons for TLH amongst the 128 patients on the short-stay pathway were pelvic pain 58 (45%), followed by adenomyosis/fibroids 27 (21%), and heavy menstrual bleeding (HMB)  (Table II). Only 58/128 (45%) of patients completed their diary with no significant difference between short-stay hysterectomy patients who ended up having <23hour stay compared to patients who had prolonged stay (38% compared to 79%; P = 0.4).

Main findings
We have presented our novel protocol for shortstay hysterectomy and the initial clinical outcomes following its implementation. This 'less than 23hour stay' LH care pathway for benign conditions, and early-stage cancer patients being discharged within 23 hours of admission, with rates of complications and representations/readmissions comparable to conventional care and high rates of patient satisfaction (Meulen et al., 2018;Jennings et al., 2015;Bruneau et al., 2015). Moreover, 48% of all patients, accounting for 60% of all those discharged within 23-hours, went home on the same day as surgery, avoiding overnight stay. Almost one in five women (19%) required stay beyond the planned 23-hours following TLH. The main barrier to compliance was the decision of the surgical team for prolonged observation due to unanticipated surgical complexity. As the care pathway becomes firmly embedded, confidence may increase and prolonged admissions reduced.
Patients with fibroids/adenomyosis were more likely to have prolonged stay beyond 23-hours compared to patients who had a hysterectomy for other indications. Patients with a prior caesarean inserted were more likely to have prolonged stay 2/24 (8%) [relative risk= 0.05 (95% CI 0.002-0.96; P= 0.05)].
The readmission rate following discharge was 5/128 (3.9%) at 30 days' post hysterectomy (Table  III). Three of these readmissions were within seven days of surgery. Of the five readmissions, three were due to Clavien-Dindo grade 1 postoperative complications; one upper respiratory tract infection, one pyelonephritis, and one portsite wound dehiscence. The other patient was readmitted on day two postoperatively and had a pelvic collection requiring laparoscopy and drainage in theatre (Clavien-Dindo grade 3b). One patient was readmitted 10 days post-operatively with a ureteric-vaginal fistula following an unrecognised thermal ureteric injury (Clavien-Dindo grade 3b). There were no relevant readmissions identified after 30 days. In total two patients required a return to theatre (2/128; 1.5%). (Table IV) The questionnaire response rate at six weeks following surgery was 62/128 (48%). Overall, most women were satisfied with their experience of short-stay hysterectomy (56/62; 90%). Assuming all non-responders were either dissatisfied or satisfied, the proportion of patients being satisfied with their experience of short-stay hysterectomy was between 56/128 (48%) and 122/128 (95%).
Significantly more women in the 23-hour stay group felt that early discharge was appropriate  section, known adhesions or intra-operative pelvic drain insertion were also more likely to stay beyond 23-hours. The enhanced surgical challenges presented by larger uteri associated with adenomyosis and fibroids, and adhesions resulting in longer duration of surgery may possibly explain the relatively prolonged post-operative recovery. Placement of a pelvic drain being indicative of complex surgery and concerns over post-operative bleeding.

Strengths and limitations
Data were collected prospectively from 128 consecutive women undergoing LH who had been placed on our pathway. However, scrutiny of our electronic operating theatre coding system showed that 289 laparoscopic hysterectomies were undertaken during our study period. Retrospective comparison of the 161 patients not included, revealed that 108 patients were eligible but not included. However, these patients were not selectively excluded but rather were omitted because of a lack of familiarity with the pilot care pathway. Based upon these data, by applying the inclusion criteria presented in our protocol, we estimate that over 80% of women undergoing LH will be eligible for this short-stay care pathway. The low response rate of around 50% to our 6-week patient satisfaction questionnaire limits robust clinical inferences being drawn. However, results were generally more favourable in women discharged within 23-hours.

Comparison with the existing literature
Concerns about early discharge after hysterectomy include high readmission rates and missed complications. In our study the readmission rate was low and reasons in this cohort included chest infection, urinary infection, ureterovaginal fistula and pelvic collection. It is unlikely that keeping these patients in for one or two more days would have been long enough for these complications to manifest clinically. Rather patient education about concerning symptoms along with 24/7 contact thromboembolism. This study shows that short-stay hysterectomy is feasible and safe without increased rates of readmission, complications or reduced patient satisfaction. Moreover, this novel pathway can be successfully introduced into hospitals where traditional practices regarding post-operative length of stay are embedded.
Patients should be counselled that most can be discharged on the same day as their surgery without the need for hospital admission. However, there is a 1 in 5 chance of needing hospital stay beyond 23-hours and the likelihood of needing longer stay is higher in the presence of adenomyosis, fibroids, previous caesarean sections and adhesions. They should also be aware that rates of satisfaction are high and be reassured that the need for readmission or of suffering complications are no higher than conventional care protocols. Large, multi-centre, randomised controlled trials comparing daycase, less than 23 hour stay and conventional care protocols are needed to evaluate the magnitude of any differences in rates of complications such as hospital acquired infections, rates of venous thromboembolism and patient satisfaction. Collection of prospective observational, real world data (e.g. establishing patient registries) is needed to better assess the safety of same day and short stay hysterectomy.

Conclusion
We developed and introduced a novel short-stay 'less than 23-hour stay' laparoscopic hysterectomy pathway. Such a pathway for TLH is feasible, with most patients being discharged on the day of surgery, and associated with high levels of patient satisfaction.
numbers to allow clinical assessment can identify problems early and improve outcomes.
In England, the mean rate of emergency readmission within 30 days of laparoscopic hysterectomies is 4.9% (Meulen et al., 2018). Our findings are in keeping with previous observational series from the USA and Europe examining the feasibility of same-day TLH reported success rate of 41.7% to 97% with readmission rate ranging from 1.4% to 8%, and up to 6% return to theatre in the first 30 days following the procedure (Doliyet et al., 2020;Thiel and Gamelin, 2003;Rivard et al., 2015;Summitt et al., 1992;Alperin et al., 2012). Furthermore, there was 20% of patients requiring prolonged hospitalisation (Doliyet et al., 2020), and 3.4% rate of conversion to laparotomy (Alperin et al., 2012). Data from a recent, large, multicentre RCT in the UK (Cooper et al., 2019) comparing laparoscopic supracervical hysterectomy and endometrial ablation, showed that postoperative hospital stay was less than 24 hours in 68% of women who were randomly allocated to laparoscopic supracervical hysterectomy, this may reflect the lack of a structured model as set out and assessed in our study.
In the context of same-day discharge following TLH, a recent RCT demonstrated that voiding within 6 hours after surgery was associated with a successful same-day discharge (Sandberg et al., 2019). The main reasons given for prolonged stay in other observational studies were pain, nausea and vomiting (Dindo et al., 2004;Jennings et al., 2015;Bruneau et al., 2015;Dolivet et al., 2020). In our study, less than 3% of women had prolonged stay due to urinary retention or excessive pain, with nausea and vomiting not recorded as a prime reason for protracted admission. This may reflect our intraoperative and postoperative protocol, removing the catheter within 4-6 hours after surgery and offering patients regular non-opioids, and antiemetic medication.

Implications for clinical practice and research
In 2020, The British Association of Day Surgery (BADS) in collaboration with Getting It Right First Time (GIRFT., 2020) produced a Day Surgery Delivery Pack highlighting the importance of considering the option of day surgery wherever possible, especially at a time when the NHS needs to re-start and catch up with demand for elective surgery following the Covid-19 pandemic. Day surgery is beneficial for both patients and the hospital as it helps to reduce waiting times. It also has financial implications by releasing valuable bed stock, reducing the burden of highly skilled staff during out-of-hours cover and minimising the risks of hospital acquired infection and venous