A Randomised Controlled Trial Comparing Outpatient Versus Daycase Endometrial Polypectomy

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 6

DOI: 10.1111/j.1471-0528.2006.00967.

x
www.blackwellpublishing.com/bjog
General gynaecology

A randomised controlled trial comparing


outpatient versus daycase endometrial
polypectomy
FA Marsh, LJ Rogerson, SRG Duffy
Academic Department of Obstetrics and Gynaecology, St James’s University Hospital, Leeds, UK
Correspondence: Dr FA Marsh, Academic Department of Obstetrics and Gynaecology, Level 9, Gledhow Wing, St James’s University Hospital,
Leeds, UK. Email medfm@leeds.ac.uk

Accepted 6 April 2006. Published OnlineEarly 2 June 2006.

Objective To evaluate outpatient versus daycase endometrial in either arm of the study. The mean intraoperative visual
polypectomy by comparing success rate, complications, patient analogue style (0–100 mm) pain score during outpatient
tolerance, pain score, analgesia requirement and recovery. polypectomy was 23.7 mm (1–62). A proportion of women (20%)
described no intraoperative discomfort; however, the majority
Design A randomised controlled trial.
(75%) described mild or moderate intraoperative discomfort.
Setting A large UK Teaching hospital. More women in the outpatient cohort (58%) described themselves
as pain free for the remainder of the day than in the daycase
Population Forty consecutive women diagnosed with an
cohort (28%) (P = 0.09). The day after the procedure, all women
endometrial polyp at outpatient hysteroscopy were randomly
from the outpatient group described slight or no discomfort
assigned in equal proportions to outpatient or daycase polyp
compared with only 41% of women from the daycase group
removal.
(P = 0.02). All women undergoing outpatient polypectomy had
Methods The outpatient cohort underwent endometrial a significantly shorter mean time away from home (3.24 [1.5–5]
polypectomy either using grasping forceps or a bipolar electrode hours) than women undergoing daycase polypectomy (7.42
(VersapointTM; Gynecare Inc., Menlo Park, CA, USA) introduced [6–10.5] hours), P < 0.0005. Similarly, women from the outpatient
down the operating channel of a rigid hysteroscope (VersascopeTM; cohort had a significantly faster mean return to preoperative fitness
Gynecare Inc.). The daycase cohort underwent traditional (1 [0–4] day versus 3.2 [1–13] days; P = 0.001) and required less
endometrial polyp resection using a hysteroscopic, monopolar, postoperative analgesia than the daycase cohort. Ninety-five
electrosurgical resecting loop, performed under general percent of women from the outpatient cohort and 82% of women
anaesthetic. from the daycase cohort stated they would prefer to undergo an
endometrial polypectomy in the outpatient setting should they
Main outcome measures The main outcome measures were as
require a further polyp removal.
follows: success rates and intra or postoperative complications,
time away from home, analgesia requirements, pain scores on Conclusion Endometrial polypectomy can be successfully
the day of and one day after endometrial polypectomy, return to performed in the outpatient setting with minimal intraoperative
work and preoperative fitness and preference for the location of a discomfort, a significantly shorter time away from home and faster
future endometrial polypectomy. recovery and is preferred by women when compared with daycase
polypectomy. Resources need to be made rapidly available to
Results The majority of women from both cohorts were
undertake larger scale research and develop this service across
premenopausal (62.5%), parous (85%) and in paid employment
the UK.
(62.5%). One woman allocated to outpatient polypectomy had
cervical stenosis and dilatation was unsuccessful in the outpatient Keywords Daycase, endometrial polyp, outpatient, polypectomy.
setting. There were no other intra or postoperative complications

Please cite this paper as: Marsh F, Rogerson L, Duffy S. A randomised controlled trial comparing outpatient versus daycase endometrial polypectomy.
BJOG 2006; 113:896–901.

bleeding.1 The true incidence is likely to be even higher as they


Introduction
are often discovered in asymptomatic women.2 Endometrial
Endometrial polyps are present in 10% of premenopausal polyps are usually benign; however, there is evidence to
and 20% of postmenopausal women with abnormal uterine confirm that they may be the site of endometrial malignancy

896 ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology


Outpatient versus daycase endometrial polypectomy

and as such should be removed, particularly in postmeno- Ethical considerations


pausal women.3,4 Endometrial polyp resection under direct Ethical approval was obtained from the Leeds Health Author-
hysteroscopic vision is more likely to completely remove the ity/St James and Seacroft University Hospitals Clinical
endometrial basalis layer, and thus reduce the risk of recur- Research (Ethics) Committee.
rence, than the more traditional approach of blind removal
with polyp forceps.5 Indeed, 10–15% of polyps may be left Informed consent
in situ when removed following blind curettage or polyp avul- Informed consent was obtained before randomisation to
sion.6 Recent advances in endoscopic instrumentation allow either outpatient or daycase endometrial polypectomy.
endometrial polyps to be removed under direct vision in
either the outpatient or daycase setting. Participants
Outpatient gynaecological diagnostic procedures, e.g. hys- Forty consecutive women diagnosed with an endometrial polyp
teroscopy, are now replacing daycase procedures due to the were recruited into the study. Twenty women were randomised
advantages for the woman and the health service. These to outpatient polypectomy and 20 to daycase polypectomy.
include the avoidance of general anaesthesia and its associated
risks, faster return to normal activities and less time away Randomisation
from home and work.7 Furthermore, there is evidence to Randomisation was achieved using sealed, opaque envelopes
suggest that outpatient gynaecological procedures provide containing computer-generated block randomisation num-
significant cost savings and are preferred by women when bers. The envelopes were opened by L.J.R on the hospital site.
compared with daycase procedures.8,9
Although it may be feasible to perform outpatient proced-
Procedure
ures, it is important that they are systematically evaluated and
compared with their traditional counterparts under general Outpatient endometrial polypectomy
anaesthesia. In particular, gynaecologists should ensure that Outpatient endometrial polypectomy was performed using
the procedure is successful, tolerable and acceptable to the a 1.8-mm, 0, semi-rigid hysteroscope with a disposable
vast majority of women in the outpatient setting. As yet, there sheath. The sheath consists of an inflow channel that houses
is little published evidence to suggest whether outpatient poly- the hysteroscope and allows for the infusion of 0.9% saline
pectomy offers any advantage over daycase polypectomy to the distension medium, at a pressure of 150–200 mmHg. The
woman or the health service. outflow channel also serves as an operative channel for the
introduction of 2-mm (7 French) instruments. The sheath
angles the tip of the hysteroscope to 10, allowing for
Objectives improved visualisation of the uterine cavity. Small endo-
The aim of this study was to evaluate outpatient versus metrial polyps were removed using grasper forceps introduced
daycase endometrial polypectomy by comparing success down the operating channel of the VersascopeTM. Larger
rate, complications, patient tolerance, pain score, analgesia polyps were first divided into smaller pieces using the Versa-
requirement and postoperative recovery. pointTM bipolar electrode and the fragments were then
removed using grasper forceps. In every case, the base of
the polyp was visualised and removed. All tissues were sent
Methods for histological diagnosis.
Study design Intraoperative discomfort in the outpatient cohort was
A randomised controlled trial comparing outpatient versus determined using the following methods:
daycase polypectomy. 1. Visual analogue style (VAS) 100-mm pain score: Women
Women with abnormal uterine bleeding underwent diag- were asked to quantitate the discomfort they had experi-
nostic outpatient hysteroscopy to investigate their symptoms. enced by placing a mark along a 100-mm horizontal line
If an endometrial polyp was identified, women were given an bounded by the descriptors (0 mm = no pain, 100 mm =
information leaflet inviting them to participate in the study. A worst pain imaginable).
polyp was diagnosed hysteroscopically as a discrete outgrowth 2. Summated (Likert) rating scale with options to describe
of endometrium protruding into the endometrial cavity pain as follows: None, mild, moderate, severe, very severe,
attached by a pedicle. worst pain ever experienced.
There was always an interval period ranging from weeks to
several months between consenting women into the trial, Daycase endometrial polyp removal
randomisation and performing the polypectomy. This inter- A week before the daycase endometrial polypectomy was
val provided women with time to consider their decision and scheduled, all women attended a preassessment clinic to
change their mind if they wished to opt out of the trial. ensure suitability and fitness for general anaesthesia.

ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology 897


Marsh et al.

Under general anaesthesia, the cervical canal was dilated to Mann–Whitney U test was used to analyse differences in
Hegar 9 and a 8.5-mm operative hysteroscope, attached to the mean discomfort experienced, analgesia requirement,
a camera system, was inserted into the uterine cavity. Sorbitol recovery and time away from home and work.
distension media was flushed through the endometrial cavity A chi-square test was used to analyse differences in women’s
using an automatic pump and low-level suction to maintain description of the two procedures. Analysis was undertaken on
visibility. Careful recording of sorbitol input and output was an intention-to-treat basis.
documented to ensure that fluid balance was maintained
throughout the procedure, with a final check at the end. All Results
endometrial polyps were removed using a monopolar, elec-
trosurgical resecting loop and were sent for histological diag- Forty-nine women diagnosed with endometrial polyps were
nosis. After recovery from the general anaesthetic, women approached and counselled about the trial. Forty women
were discharged home under the supervision of a family agreed to participate and consequently 20 women were ran-
member or friend. domised to outpatient endometrial polypectomy and 20 to
daycase endometrial polypectomy. Nineteen (95%) women
Materials from the outpatient cohort returned their diary and 17
On the day of the endometrial polypectomy, women from (85%) returned their diary from the daycase cohort.
both cohorts were asked to specify an overall pain score All four nonresponders were sent a written reminder but
describing the discomfort they had experienced as a result failed to return their diaries.
of the procedure. The options provided ranged as follows: The majority of women in this study were premenopausal,
0 = No pain at rest or on movement. parous and in paid employment (Table 1). A flow of women
1 = No pain at rest, slight pain on movement. through the trial is shown in Figure 1.
2 = Slight pain at rest, moderate pain on movement.
3 = Moderate pain at rest, severe pain on movement. Failure rate and complications
4 = Severe pain at rest and on movement. One woman allocated to outpatient endometrial polypectomy
Women also specified the overall discomfort they experi- had cervical stenosis and dilatation was unsuccessful in the
enced the day after endometrial polypectomy using the same outpatient setting. This woman subsequently underwent
scale cited above. endometrial polypectomy as a daycase under general anaes-
thesia. A second woman allocated to the outpatient arm of the
Follow up
study had no visible endometrial polyp when she attended for
All women completed a diary, recording time away from home
polypectomy and an endometrial biopsy was simply taken.
on the day of the endometrial polypectomy, analgesia require-
There were no other intra or postoperative complications
ment, return to preoperative fitness and work following the
in either arm of the study. Good-sized samples were taken in
procedure. Women documented whether they would prefer
all cases allowing for adequate histological assessment. All the
to undergo an endometrial polypectomy as an outpatient or
polyps removed in this study were benign.
daycase procedure were they to require it again in the future.
Women chose up to three adjectives to describe the pro-
Intraoperative discomfort during outpatient
cedure they had undergone. The adjectives were as follows:
endometrial polypectomy
h Interesting
The mean intraoperative VAS pain score was 23.7 mm with
h Quick
a range of 1.0–62.0 mm. Four women (20%) described the
h Convenient
procedure as painless. However, the majority of women (75%
h Thorough
h Intimidating
h Unpleasant Table 1. Demographic data

h Embarrassing
Outpatient Daycase P value
h Painful. cohort cohort
Hence, women had the option of describing the experience (n 5 20) (n 5 20)
they had undergone in a positive and/or negative manner.
Mean age, years (range) 50.5 (37–72) 50.0 (37–79) N/S
Statistical analysis Women in paid 12 (60) 13 (65) N/S
The results were managed by Statistical Package for the Social employment, n (%)
Sciences (SPSS; SPSS Inc., Chicago, IL, USA). Sample char- Nulliparous women, n (%) 3 (15) 3 (15) N/S
acteristics were determined using descriptive statistics. T tests Postmenopausal women, n (%) 8 (40) 7 (35) N/S

were used to analyse data that approximated to a normal


N/S, not statistically significant (i.e. P . 0.05).
distribution, e.g. age.

898 ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology


Outpatient versus daycase endometrial polypectomy

49 women eligible to be
recruited into trial

9 women declined to
participate in trial

40 women randomised

20 women allocated to outpatient 20 women allocated to daycase


endometrial polypectomy endometrial polypectomy

1 woman had cervical stenosis;


underwent daycase
polypectomy

18 women underwent outpatient 20 women underwent daycase


polypectomy, 1 woman had no visible polypectomy (3 women did not return
polyp and underwent hysteroscopy and follow-up questionnaires)
endometrial biopsy (all women returned
follow-up questionnaires)

Figure 1. A flow of women through the trial.

n = 15) described mild or moderate intraoperative pain with the daycase group, 41% of women described no pain at all and
only one woman describing severe pain (Table 2). The pain 18% described moderate pain on movement the following
scores and Likert style description from all 20 women allo- day (P = 0.03) (Figure 3).
cated to outpatient endometrial polypectomy were included
in keeping with intention-to-treat analysis. Time away from home and analgesia
requirements as a result of the endometrial
Overall description of discomfort on day of polypectomy
and day after endometrial polypectomy Women undergoing outpatient endometrial polypectomy
On the day of the procedure, 58% of women undergoing had a significantly shorter mean time away from home than
outpatient polypectomy described no pain at all compared those undergoing the daycase procedure. Similarly, signifi-
with only 28% of the daycase group (P = 0.09) (Figure 2). cantly fewer women undergoing outpatient polypectomy
The day after the procedure, there was a statistically signifi- required postoperative oral analgesia compared with those
cant difference in the severity of pain experienced by women undergoing the daycase procedure. Women from the outpa-
in the outpatient versus daycase cohorts. All women from the tient cohort also returned to preoperative fitness significantly
outpatient cohort described either no pain at all (74%) or
only slight pain on movement (26%) the following day. In

Table 2. Likert style description of pain

n (%)

None 4 (20)
Mild 9 (45)
Moderate 6 (30)
Severe 1 (5)
Very severe 0
Worst pain ever experienced 0
Figure 2. Severity of pain on the day of endometrial polypectomy.
OP, outpatient; DC, daycase.

ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology 899


Marsh et al.

Figure 4. Adjectives women chose to describe their experience


of the endometrial polypectomy. OP, outpatient; DC, daycase.
Figure 3. Severity of pain the day after endometrial polypectomy.
OP, outpatient; DC, daycase.
has shown that outpatient endometrial polypectomy can be
faster than the daycase cohort and returned to work, on aver- successfully performed in the vast majority of women. There
age, a day earlier (Table 3). was only one woman in which outpatient polypectomy was
unsuccessful.
Women’s description of and satisfaction These findings are similar to a feasibility cohort study of
with the procedure outpatient endometrial polypectomy in which all 31 women
All women from the outpatient cohort, bar one (n = 18), allocated to this procedure underwent successful outpatient
stated that they would choose to undergo a repeat outpatient endometrial polypectomy.10 The majority (65%) of women in
polypectomy were they to require the procedure again. our study, undergoing outpatient polypectomy, described
Fourteen women (82.4%, n = 14/17) from the daycase either none or mild intraoperative discomfort, with a mean
cohort would prefer to undergo an outpatient endometrial intraoperative VAS pain score being 23.7 mm. Indeed, more
polypectomy if they needed the procedure in the future. Thus, women from the outpatient cohort described none or mild
only three women (17.6%) would opt for a daycase endome- discomfort on the day of and day after endometrial polypec-
trial polypectomy again. The majority of adjectives used to tomy than from the daycase cohort. Our findings confirm
describe both outpatient and daycase endometrial polypec- that it is both feasible and preferable to women to undergo
tomy were positive; however, women from the outpatient endometrial polypectomy in the outpatient setting.
cohort used significantly more positive adjectives than These findings have important implications for the future
women form the daycase cohort (44/49 [90%] versus 28/42 of clinical practice. A national survey investigating the current
[67%]; P < 0.0005) (Figure 4). UK practice for the treatment of endometrial polyps11 showed
that over 90% of gynaecologists remove intrauterine polyps
and that 90% of these polypectomies are performed as an
Discussion inpatient procedure, using blind avulsion under general
This is the first randomised controlled trial comparing out- anaesthetic. One of the most important advantages of this
patient versus daycase endometrial polypectomy. This study study is that outpatient endometrial polypectomy was per-
formed in a true outpatient setting, without local anaesthetic
or intravenous sedation and requiring only a short time away
Table 3. Time away from home and recovery data
from home. This service offers several advantages over the
Outpatient Daycase P value traditional method of polyp removal still commonly under-
cohort cohort taken in the UK including less time away from home, faster
(n 5 19) (n 5 17) return to preoperative fitness and obviates the need and costs
of an anaesthetist, operating department assistant and oper-
Mean hours away 3.25 7.42 ,0.0005 ating theatre. The polyp is also removed under direct vision,
from home
rather than blind avulsion, thus reducing the risk of recur-
No. of women requiring 4 (21) 9 (53) 0.05
postoperative oral
rence. The availability to perform outpatient endometrial poly-
analgesia, n (%) pectomy immediately following diagnosis in an outpatient
Mean time to return to 1 (0–4) 3.2 (1–13) 0.001 hysteroscopy clinic expedites treatment and avoids the risks
preoperative fitness (days) and further waiting time prior to a polypectomy under gen-
Mean time off work 2.3 (1–5), 3.4 (1–5), N/S eral anaesthesia. Furthermore, there is evidence to suggest
(days [range]) n 5 12 n 5 11 that substantial health service cost savings would result from
transferring endometrial polypectomy from the daycase to the
N/S, not statistically significant (i.e. P . 0.05).
outpatient setting.9,10

900 ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology


Outpatient versus daycase endometrial polypectomy

The small numbers of women included in this trial is References


a limitation of the study. It became increasingly difficult
1 Reslova T, Tosner J, Resl M, Kugler R, Vavrova I. Endometrial polyps.
to recruit for the study as progressively more women A clinical study of 245 cases. Arch Gynecol Obstet 1999;262:
became aware that outpatient polypectomy was being per- 133–9.
formed within the unit. Many women with polyps directly 2 Taylor LJ, Jackson TL, Reid JG, Duffy SRG. The differential expression of
requested an outpatient polypectomy and were not prepared oestrogen receptors, progesterone receptors, Bcl-2 and Ki67 in endo-
metrial polyps. BJOG 2003;110:794–8.
to be randomised. Nonetheless, a larger randomised con-
3 Anastasiadis PG, Koutlaki NG, Skaphida PG, Galazios GC, Tsikouras PN,
trolled trial is required to determine whether our results Liberis VA. Endometrial polyps: prevalence, detection, and malignant
are generalisable. This trial would require long-term follow potential in women with abnormal uterine bleeding. Eur J Gynaecol
up in order to compare operative complications, symptom- Oncol 2000;21:180–3.
atic cure rates, polyp recurrence rate and a cost analysis of 4 Pettersson B, Adami HO, Lindgren A, Hesselius I. Endometrial polyps
and hyperplasia as risk factors for endometrial carcinoma. A case-
the two procedures.
control study of curettage specimens. Acta Obstet Gynecol Scand
A ‘one stop’ direct access clinic for the investigation and 1985;64:653–9.
treatment of abnormal uterine bleeding is the future of gynae- 5 Nagele F, Mane S, Chandrasekaran P, Rubinger T, Magos A. How
cological ambulatory services. Women diagnosed with endo- successful is hysteroscopic polypectomy? Gynaecol Endosc 1996;5:
metrial polyps would benefit from the convenience of 137–40.
6 Maja H, Barbosa IC, Farias JP, Ladipo OA, Coutinho EM. Evaluation of
immediate treatment, avoid a general anaesthetic and make
the endometrial cavity during menopause. Int J Gynaecol Obstet
a faster postoperative recovery. In light of the NHS Plan to 1996;52:61–6.
provide a ‘patient-led service’ and target resources towards 7 Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient
the preference of patients, this study highlights the need to hysteroscopy versus day case hysteroscopy: randomised controlled
increase the provision of an outpatient endometrial polypec- trial. BMJ 2000;320:279–82.
8 Marsh FA, Taylor L, Kremer C, Black J, Duffy S. Delivering an effective
tomy service to more women in the UK.
outpatient service in gynaecology. An assessment of patients’ prefer-
ence. Gynaecol Endosc 2002;11:337–43.
Conclusion 9 Marsh FA, Kremer SD, Duffy S. A randomised controlled trial analysing
the cost of outpatient versus daycase hysteroscopy. BJOG 2004;
Endometrial polypectomy can be successfully performed in 111:243–8.
the outpatient setting with minimal intraoperative discom- 10 Clark J, Godwin J, Khan K, Gupta J. Ambulatory endoscopic treatment
fort. Outpatient polypectomy is associated with a significantly of symptomatic benign endometrial polyps: a feasibility study. Gynae-
col Endosc 2002;11:91.
shorter time away from home, faster recovery and is preferred
11 Clark TJ, Khan KS, Gupta JK. Current practice for the treatment of
by women when compared with daycase polypectomy. benign intrauterine polyps: a national questionnaire survey of consul-
Resources need to be made rapidly available to undertake tant gynaecologists in UK. Eur J Obstet Gynecol Reprod Biol 2002;
larger scale research and develop this service across the UK. j 103:65–7.

ª RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology 901

You might also like