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European Journal of Obstetrics & Gynecology and Reproductive Biology 252 (2020) 412–417

Contents lists available at ScienceDirect

European Journal of Obstetrics & Gynecology and


Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Full length article

AMeTHYST (AMbulatory HYsterectomy surgery). Feasibility of


minimally invasive outpatient hysterectomy, a preliminary study
Enora Doliveta,b , Arthur Foulonc , Thérèse Simonetd, Sophie Sanguinc, Mélusine Turcka ,
Anne-Cécile Pizzoferratoa , Raffaèle Fauveta,e,*
a
Department of Gynaecology, Obstetrics, and Reproductive Medicine, University Hospital of CAEN, France
b
Surgery Department, Centre François Baclesse, Caen, France
c
Department of Gynaecology, Obstetrics, and Reproductive Medicine, University Hospital of AMIENS, France
d
Department of Anesthesiae, University Hospital of CAEN, France
e
Caen Normandie University, Inserm U1086 « ANTICIPE », Unité de Recherche Interdisciplinaire pour la Prévention et le Traitement des Cancers, Axe 2 :
Biologie et Thérapies Innovantes des Cancers Localement Agressifs (BioTICLA), France

A R T I C L E I N F O A B S T R A C T

Article history: Objectives: Hysterectomy, one of the most frequent surgical procedures in women, is commonly
Received 17 April 2020 performed by a minimally-invasive approach (laparoscopic or vaginal) as recommended by the French
Received in revised form 30 June 2020 guidelines. The French authorities aim to have 66 % of all procedures performed as same-day surgery in
Accepted 10 July 2020
2020. The aim of this study was to evaluate the feasibility and identify factors associated with success or
failure of same-day surgery for minimally-invasive hysterectomy.
Keywords: Study design: We conducted a prospective double-center observational study at the Caen and Amiens
Hysterectomy
University Hospitals between September 2017 and May 2018 including hospitalized patients managed
Same-day
Mini-invasive surgery
for a laparoscopic or vaginal hysterectomy. Patients were younger than 70 and have no major medical
problems. The patients were placed into a “fit” or “unfit” group according to their Post Anaesthetic
Discharge Scoring System (PADSS) score 6 h post-surgery. All the patients were asked to complete an
assessment questionnaire during their hospitalization.
Results: Of the 50 included patients, half were placed in the "fit" group. A history of laparotomy was
significantly predictive of failure of same-day discharge (p = 0.003) but not uterine size or Body Mass Index
(BMI). The main barriers for discharge were pain (p<0.001) and postoperative nausea/vomiting (PONV)
(p<0.001). Four patients, all in the “unfit” group, had Clavien-Dindo grade 1 postoperative complications.
Conclusion: Same-day minimally invasive hysterectomy is a feasible and safe procedure. Factors associated
with same-day hysterectomy failure were laparotomy, pain and postoperative nausea/vomiting.
© 2020 Published by Elsevier B.V.

Introduction been conducted showing a failure rate of between 3.6 and 11.5 %
[5–12] and patient satisfaction rate of over 95 % [9,10]. In France,
Over 62,000 hysterectomies were performed in France in 2018, 2/ only four such studies have been carried out [13–16]. Overall, the
3 of which were by minimally invasive pathways [1,2]. In France, performance of same-day hysterectomy remains limited in
outpatient surgery is defined as hospitalization for up to 12 h without France. The main obstacles to performing minimally invasive
an overnight stay [3] and is associated with both medical and outpatient hysterectomy are postoperative pain, medico-social
economic benefits. However, France lags behind the development of habits and administrative constraints [16]. Foulon et al., con-
outpatient surgery compared to other European countries [4]. ducted a survey of 152 surgeons performing laparoscopic/vaginal
Outpatient hysterectomy is highly developed in the United hysterectomy and showed that the criteria affecting eligibility for
States and the United Kingdom and several studies have already outpatient hysterectomy were anesthetic, uterine size, Body Mass
Index (BMI), duration of intervention and intraoperative bleeding
[17].
The aim of our study was to evaluate the feasibility of
* Corresponding author at: Department of Gynaecology, Obstetrics, and
outpatient minimally invasive hysterectomy in a population of
Reproductive Medicine, University Hospital of Caen, Avenue Côte de Nacre,
14000 Caen, France. women selected according to the criteria defined by the study by
E-mail address: fauvet-r@chu-caen.fr (R. Fauvet). Foulon et al., [17].

https://doi.org/10.1016/j.ejogrb.2020.07.019
0301-2115/© 2020 Published by Elsevier B.V.
E. Dolivet et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 252 (2020) 412–417 413

Materials and methods two because of non-removal of the urinary catheter at the end of
the surgery, and one because of a history of acute urine retention).
This was a prospective double-center observational study. Finally, 50 patients were retained for analysis.
Patients were prospectively included between September 2017 The mean PADSS score 6 h after the surgery was 8.2 +/- 0.2 in
and May 2018. The study was approved by the South Mediterra- our study. Twenty-five patients (50 %) had a PADSS score  9 (i.e.,
nean Ethics Committee (CPP Sud-Méditerranée, ID RCB: 2017- considered eligible for home discharge) and were place in the “fit”
A01505 48) and registered on ClinicalTrials.gov (NCT03290339). group, and 25 (50 %) a score <9 and were placed in the “unfit”
The inclusion criteria were patients older than 18 years who group. Of the total population initially eligible for an outpatient
underwent laparoscopic or vaginal hysterectomy for benign or procedure, 41.7 % (25/60) were fit for home same-day discharge.
malignant disease. The criteria for non-inclusion were an age over These data are shown in the patient flow chart (Fig. 1).
70 years, a history of coronary artery disease or sleep apnea The clinical and socio-demographic characteristics of the
syndrome, long-term use of curative anticoagulants or antiplatelet patients are summarized in Tables 1 and 2. Most of the indications
agents and concomitant surgical intervention (excluding unilateral for the surgery were for benign conditions (43/50, 86 %) and 14 %
or bilateral adnexectomy). Any patient requiring conversion to were for malignancy (7/50), with no difference between the “fit”
laparotomy was also excluded from analysis. and “unfit” groups (p = 0.42).
The patients were recruited during the preoperative consulta- The mean postoperative uterine weight was 190.1 +/- 22.2 g in
tion. The choice of surgical route was at the discretion of the the "fit" group and 191.4 +/- 33.7 g in the "unfit" group (p = 0.48).
surgeon and the patient stayed on a conventional ward at least
overnight after the surgery. The anesthesia team developed a Surgical data (Table 3)
standardized per- and postoperative protocol based on multimodal
analgesia and early rehabilitation; the urinary catheter was Forty-four patients underwent hysterectomy by laparoscopy
removed at the end of the procedure. and six by the vaginal route.
Preoperative clinical and pathologic characteristics were All the operators used four trocars for the laparoscopic
collected from the patients’ medical charts. The hospitalization procedures; all the trocar sites were infiltrated with ropivacaine
data were collected prospectively using a case report form. without significant difference between the two groups.
Histologic data collected consisted of uterine measurements and The medications and doses administered intraoperatively were
weight. similar in the two groups apart from tramadol which was
The nurse recorded the PADSS score for each patient at 6 p.m. or administered to 48 % of the patients in the “unfit” group compared
6 h after the surgery. with 20 % in the "fit" group (p = 0.04) ().
The patients were asked to complete an assessment question-
naire the evening of the surgery and the day after surgery. The Postoperative period (Table 4)
questions asked on the evening of surgery were: “Would you feel
physically fit to be discharged?” with the answers “Yes” or “No” and Patients in the "unfit" group received significantly more
“If No, why not?”; “Can you grade the following symptoms from 0 tramadol over this period (28 % versus 0%, p = 0.01). There was
to 10? Pain / Nausea / Vomiting and Fatigue?”. no difference in the use of grade 1 analgesics (Non-Steroidal Anti-
The same questions were asked the day after surgery and the Inflammatory Drugs (NSAIDs), paracetamol and nefopam) be-
following questions were added: “If your surgeon had given you tween the two groups. We found a significant difference in the use
the option to undergo this outpatient surgery would you have of antiemetics in the postoperative period between the two groups
accepted?” ; “and “Would you recommend outpatient care for this (p = 0.02).
procedure to one of your friends?”; with the answers “Yes” or “No. Forty-nine of the 50 patients responded to the first part of the
Two study periods were defined as follows: the "post- questionnaire: the patient who did not answer was one of the two
operative" period starting from discharge from the post-operative patients who were home discharged on the evening of the
recovery room to the ward up to when the Post Anaesthetic procedure. To the question, "Would you feel physically fit to go
Discharge Scoring System (PADSS) score was calculated; and the out?” on the evening of the procedure, 36 % (9/25) of the "fit" group
"night" period which covered the night up to the next day. and 4 % (1/25) of the "unfit" group responded yes (p = 0.01). The
Our primary endpoint was the PADSS score [18], that defined pain, and postoperative nausea and vomiting (PONV) scores were
two groups: a “fit” group comprising patients scoring 9
(considered to be eligible for home discharge); or an “unfit” group
comprising patients scoring <9 or with a contraindication for
home discharge according to the surgeon or anesthetist.
Descriptive analyzes specify the mean (m) and the standard
error of the mean (SEM) for each quantitative variable and the
percentages (%) and the size (n) are defined. Student’s t-tests were
used to compare quantitative data and Chi2 or Fisher exact tests to
compare qualitative data. Analyses were conducted using the
BiostaTGV tool (biostatgv.sentiweb.fr). A p < 0.05 was considered
significant.

Results

Sixty patients were recruited in the two university hospital


centers. Of these, 10 were excluded: three because of conversion to
laparotomy (all three for uncontrollable bleeding during laparos-
copy); three who withdrew their consent to participate in the
study; and four were excluded by the surgeons (one because of the
intraoperative discovery of endometriosis complicating surgery, Fig. 1. Flow chart.
414 E. Dolivet et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 252 (2020) 412–417

Table 1
Clinical characteristics of the patients.

All patients (n = 50) Fit group Unfit group P


(n = 25) (n = 25)
Age. m +/- SEM 47.4 +/- 1.1 46.3 +/- 1.6 48.5 +/- 1.6 0.17
BMIa (kg/m2). m +/- SEM 27.1 +/- 0.8 27.6 +/- 1.1 26.6 +/- 1.0 0.25
Active smoking. n (%) 14 (28) 6 (24) 8 (32) 0.53
ASAb score. m +/- SEM 1.7 +/- 0.1 1.7 +/- 0.1 1.8 +/- 0.1 0.40
Cesarean history. n (%) 14 (28) 4 (16) 10 (40) 0.12
Laparotomy history. n (%) 16 (32) 4 (16) 12 (48) 0.003
Contraindication to NSAIDc n (%) 8 (16) 5 (20) 3 (12) 0.44
Indications : n (%) 21 (42) 11 (44) 10 (40) 0.95
Fibroma 12 (24) 5 (20) 7 (28) 0.77
Adenomyosis 4 (8) 2 (8) 2 (8) 0.51
Cervical pathologies 4 (8) 3 (12) 1 (4) 1
Endometrial cancer 3 (6) 1 (4) 2 (8) 0.61
Gender dysphoria 3 (6) 1 (4) 2 (8) 1
Prophylaxis 2 (4) 1 (4) 1 (4) 1
Endometrial hyperplasia 1 (2) 1 (4) 0 (0) 1
Ablation of ESSURE device 1
Preoperative imaging: 35 (70) 19 (76) 16 (64) 0.27
Ultrasound, n (%) 24 (69) 13 (68.4) 11 (68.8)
MRId , n (%) 6 (31) 6 (31.6) 5 (31.2)
Uterine size (major axis in mm), m +/- SEM 91.5 +/- 3.4 93.5 +/- 4.2 89.1 +/- 5.6
a
BMI: Body Mass Index.
b
ASA score: American Society of Anesthesiologist physical status score.
c
NSAID: Nonsteroidal Antiinflammatory Drug.
d
MRI: Magnetic Resonance Imaging.

Table 2 higher in the “unfit” group than in the ‘fit” group. The fatigue score
Sociodemographic characteristics of the patients. was high in both group but higher in the “unfit” group than in the
“fit” group with no significant difference (6.8 +/- 0.6 versus 5.4 +/-
All patients Fit group Unfit group P
(n = 50) (n = 25) (n = 25) 0.7, p = 0.05) ().
Marital status: n (%) 11 (22) 6 (24) 5 (20) 0.58
Single 37 (74) 19 (76) 18 (72) Night following the intervention (Table 5)
In a relationship 2 (4) 0 (0) 2 (8)
Unknown There was no difference in the use of grade 1 or 2 analgesics.
Household members: n (%) 6 (12) 2 (8) 4 (16) 0.67 Fifty-two percent (25/48) of patients did not call the health care
Alone 31 (62) 16 (64) 15 (60) 0.11
Presence of child
team during the night. Pain was the main reason for calling in 22.9
Home to hospital distance: 40.9 +/- 6.5 37.3 +/- 5.2 44.4 +/- 11.8 0.29 % (11/48) of the patients with no significant difference between the
Distance (min), m +/- SEM 6 (12) 1 (4) 5 (20) 0.19 two groups.
Distance >60 min, n (%) Twenty-seven percent (13/48) of the patients answered yes to
Activity: n (%) 30 (60) 17 (68) 13 (52) 0.06
the question “Would you have agreed to outpatient care?”: 30.4 %
Employee 1 (2) 0 (0) 1 (4) 0.25
Self-employed 5 (10) 0 (0) 5 (20) 1 in the "fit" group (7/23) and 24 % (6/25) in the "unfit" group (p =
Unemployed 4 (8) 3 (12) 1 (4) 0.05 0.74). Twenty-three percent (11/48) of the patients claimed they
Retired 5 (10) 4 (16) 1 (4) 0.61 would recommend outpatient care for hysterectomy to a relative:
Housewife 3 (6) 1 (4) 2 (8) 0.35 30.4 % (7/23) versus 16 % (4/25) in the "fit" and "unfit” group
Other 1
respectively (p = 0.49).

Table 3
Intraoperative data.

All patients Fit group Unfit group p


(n = 50) (n = 25) (n = 25)
Surgical approach: n (%) 44 (88) 23 (92) 21 (84) 0.67
Laparoscopy 6 (12) 2 (8) 4 (16)
Vaginal route
Timing of the procedure: 35 (70) 19 (76) 16 (64) 0.35
Before 12 AM, n (%) 120.0 +/- 5.0 119.0 +/- 5.0 120.0+/- 8.0 0.49
Operating time in min, m +/- SEM
Complications: 140.6 +/-17.6 104.4 +/-13.7 156.0+/- 31.2 0.02
Bleeding in ml, m +/- SEM
Associated surgical act: n (%) 12 (24) 5 (20) 7 (28) 0.51
Adhesiolysis
Evaluation of surgery: n (%) 18 (36) 10 (40) 8 (32) 0.38
Easy 24 (48) 13 (52) 11 (44) 0.56
Without major difficulty 8 (16) 2 (8) 6 (24) 0.57
Difficult 0.25
E. Dolivet et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 252 (2020) 412–417 415

Table 4
Clinical data on the "postoperative" period and questionnaire data at 6 PM or at 6 h of the procedure.

All patients Fit group Unfit group p


(n = 50) (n = 25) (n = 25)
Pain and analgesics: n (%) 23 (46) 9 (36) 14 (56) 0.16
Pain score (at least once): [3–6] 8 (16) 1 (4) 7 (28) 0.05
Pain score (at least once): [6–10] 8 (16) 3 (12) 5 (20) 0.70
Grade 3 analgesics
Nausea and antiemetics use: n (%) 18 (36) 3 (12) 15 (60) < 0.001
PONVa 9 (18) 1 (4) 8 (32) 0.02
Ondansetron
Postoperative rehabilitation: 427.0 +/- 29.0 376.0 +/- 28.0 473.0 +/- 47.0 0.04
Time to first food intake in min 369.0 +/- 24.0 323.0 +/- 38.0 438.0 +/- 38.0 0.01
Time to first getting out of bed in min 360.0 +/- 24.0 315.0 +/- 18.0 417.0 +/- 48.0 0.03
Time to the first urination in min
Questionnaire: 10 (20) 9 (36) 1 (4) 0.01
Physically fit to go out, n (%) 4.7 +/- 0.4 4.0 +/- 0.4 5.5 +/- 0.5 0.02
Pain evaluation (0 10), m +/- SEM 2.1 +/- 0.5 0.9 +/- 0.4 3.5 +/- 0.8 0.003
Nausea evaluation (0 10), m +/- SEM 1.1 +/- 0.4 0.4 +/- 0.3 1.9+/- 0.7 0.03
Vomiting evaluation (0 10), m +/- SEM 6.1 +/- 0.4 5.4 +/- 0.7 6.8 +/- 0.6 0.05
Fatigue evaluation (0 10), m +/- SEM
a
PONV: postoperative nausea and vomiting.

The mean length of stay was 2.26 +/- 0.88 days. This became our "fit" patients who could have spent the night at home without
1.39 +/- 0.1 days after exclusion of a patient who remained risk of complication. The main barriers to home discharge were
hospitalized for 45 days: 1.08 +/- 0.1 in the “fit” group and 1.71 +/- pain, nausea and vomiting scores and the use of antiemetics, but
0.17 in the “unfit” group (p = 0.001). Eighty-three percent of also a sensation of fatigue described by the patients.
patients in the "fit" group were discharged the day after the Most studies examining the feasibility of same-day minimally
procedure vs 44 % of the "unfit" group (p = 0.01). Four patients in invasive hysterectomy procedures report higher success rates than
the "unfit" group (16 %) had acute postoperative urine retention our study, ranging from 88 % to 96.9 % vs 41.7 % in our population
requiring intermittent catheterization. No patient in the "fit" group [6,8,10–15]. However, these studies present inclusion and exclu-
experienced a complication during either of the two periods. Six sion criteria prone to subjectivity. Bruneau et al., in a retrospective
patients had postoperative complications after the day of the study including 47 patients undergoing laparoscopic hysterecto-
procedure with a median onset of 15 days (interquartile range, IQR: my, reported a success rate of 89 % [13]. However, the inclusion
5–29): four patients had grade I complications according to the criteria were not clearly defined and the option of outpatient
Clavien-Dindo classification; one patient had a grade IIIb surgery remained at the surgeon’s discretion. In another French
complication 48 days post-operatively (disunity of the vaginal study of 65 patients treated for vaginal hysterectomy the success
scar); and one patient had a grade IV complication (stercoral rate was 96.9 % [15] but patients with a surgical or anesthetic
peritonitis which required colostomy after 2 days and was contraindication were excluded. In our study, patients were not
hospitalized in intensive care) (). selected according to surgical criteria, which explains our
conversion to laparotomy rate of 5% and our lower rate of
Discussion suitability for same-day discharge.
Contrary to Foulon et al.’s study [17], neither the height nor the
In this prospective cohort of 50 patients managed for minimally weight of the uterus were criteria for failure of outpatient
invasive surgery hysterectomy, 50 % could have returned home the management in our study. These results are consistent with those
same day. The night following the procedure presented no risk to of Alperin et al., who retrospectively studied the postoperative

Table 5
Clinical data collected during the "night" period and questionnaire data the day after surgery.

All patients Fit group Unfit group P


(n = 48) (n = 23) (n = 25)
Pain and analgesics: n (%) 16 (33.3) 7 (30.4) 9 (36) 0.54
Pain score (at least once): [3–6] 5 (10.4) 2 (8.7) 3 (12) 1
Pain score (at least once): [6–10] 5 (10.4) 1 (4.3) 4 (16) 0.35
Grade 3 analgesics
Nausea and antiemetics: n (%) 8 (16.7) 2 (8.7) 6 (24) 0.25
PONVa 3 (6.3) 2 (8.7) 1 (4) 0.60
Ondansetron
Nurse call: 1.2 +/- 0.2 1.1 +/- 0.3 1.3 +/- 0.3 0.33
Average number of calls, m +/- ICm 23 (47.9) 9 (39.1) 14 (56) 0.16
At least one call, n (%)
Questionnaire: 4.9 +/- 0.4 4.7 +/- 0.7 5.1 +/- 0.5 0.29
Night evaluation (0 10), m +/- SEM 3.4 +/- 0. 3 3.1 +/- 0.5 3.7 +/- 0.5 0.19
Pain evaluation (0 10), m +/- SEM 0.6 +/- 0.2 0.3 +/- 0.2 0.9 +/- 0.3 0.08
Nausea evaluation (0 10), m +/- SEM 0.3 +/- 0.1 0.2 +/- 0.2 0.3 +/- 0.2 0.38
Vomiting evaluation (0 10), m +/- SEM 9 (18.8) 7 (30.4) 2 (8) 0.14
Acceptance of spend the night at home, n (%) 36 (75) 19 (82.6) 17 (68) 0.53
Ability to manage analgesics at home, n (%)
a
PONV: Post-operative nausea and vomiting.
416 E. Dolivet et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 252 (2020) 412–417

complications of 446 patients with uteri over 500 g [6]. In their overnight stay group, one third in the outpatient group chose
study, 92.8 % of the patients were discharged the same evening, overnight stay without medical indication [23] This suggests that
and the rate of conversion to laparotomy was 3.4 %. preparing patients for outpatient management is essential.
In a literature review about minimally invasive hysterectomy, a
BMI > 30 kg / m2 was associated with an increased risk of Conclusion
conversion to laparotomy (OR = 3.11; 95 % CI[1.25–7.77]) [19].
Nevertheless, within our population there was no difference Our study shows that outpatient management of hysterectomy
between the two groups with respect to BMI. for minimally invasive pathways is legitimate and safe, and that
In our cohort, a history of laparotomy was a significant criterion there are few preoperative predictors of failure other than a history
of failure for outpatient management (48 vs 16 % in “unfit” and “fit” of laparotomy. The main barriers to same-day discharge are pain,
group, p = 0.003). In Zakaria et al.’s study, out of 1071 outpatient PONV, and fatigue.
vaginal hysterectomies with a success rate of 96 %, 20 % of the They certify that they have no financial or intellectual conflict of
patients had a history of pelvic surgery [8]. Although this surgical interests.
history does not seem to be a contraindication for outpatient
management, it is associated with a significant risk of failure. This Disclosure of interests
could be secondary to a more complicated surgical procedure in
these patients. In our study, the operative time was similar in both We have no direct or indirect commercial financial incentive
groups but intraoperative bleeding was significantly greater in the associated with publication of the article.
"unfit" group. There was no difference with respect to performing
adhesiolysis or not and even if surgery tended to be rated as being Contribution to authorship
more difficult overall in the "unfit" group than in the "fit" group,
this was not significant (24 % versus 8% respectively, p = 0.25). RF, AF and TS contributed to study design. ED, AF, SS, MT, ACP
In our study, only 20 % of the patients claimed to feel fit for and RF contributed to data collection. ED, RF, AF and ACP
discharge the evening of the procedure. Pain and PONV were the contributed to analysis and interpretation of data and article
main reasons mentioned as a barrier to discharge by our patients. writing and revision.
Eighty-four percent of our patients were administered dexameth-
asone intraoperatively for the prevention of PONV with no Declaration of Competing Interest
difference between the two groups. These factors thus constitute
a challenge for the outpatient care of these patients both per- and All authors agree with the submission of the manuscript.
postoperatively [20].
The majority of patients in the "fit" group were home
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