Download RESEARCH PROPOSAL FOR MSc DISSERTATION

PROPOSAL FOR NECN ENDOMETRIAL CANCER AUDIT
Title:
The Surgical Management of Endometrial Cancer in a Regional Gynaecological
Cancer Network in the United Kingdom – Factors Influencing the Choice of Surgical
Method and a Prospective, Multi-Centre Audit of Practice and Outcomes.
Summary:
The UK National Institute for Health & Clinical Excellence (NICE) has issued
guidance on laparoscopic hysterectomy as a surgical treatment for endometrial
cancer (Interventional Procedure Guidance 356, NICE, September 2010), stating that
evidence, on efficacy and safety, is adequate to support use of this procedure.
However, this procedure is not used (or may not be available) for all patients
diagnosed with endometrial cancer in the North of England Cancer Network (NECN)
although there are advocates for these methods. Perceived reasons have not been
assessed but may include lack of theatre operating-time, patient co-morbidities, as
well as lack of trained gynaecological surgeons. Consequently it is possible that
there is a lack of equity in provision of surgical options for patients diagnosed with
endometrial cancer in the NECN.
As part of the annual audit program the Gynaecological Cancer Site Specific Group
(SSG) of the NECN will undertake a mandatory 12-month prospective multi-centre
audit of the treatment of cases of newly diagnosed endometrial cancer in the NECN
gynaecological cancer units and centres. As well as collecting data to assess
compliance with established national management guidelines, the audit will collect
data on the overall surgical management of endometrial cancer cases in the NECN.
For laparoscopic procedures the data will be analyzed to confirm whether efficacy in
the short-term and safety is comparable to the quoted figures in the NICE guidelines
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and differ from open surgery. Data will also be collected at the time of surgery to
assess whether there are identifiable factors that influence the choice of surgical
method in treating endometrial cancer in the NECN. By this method the
Gynaecological Cancer SSG will assess whether it can to recommend laparoscopic
treatment of the disease and justify its adoption as standard management when
possible. Resources can then be targeted as required to assist in any
recommendations.
Background
Endometrial cancer is the fourth commonest female cancer in the United Kingdom
and the commonest gynaecological cancer. It accounts for 5% (7536 cases in 2007)
of female cancers with 5-year survival of 75% and 1741 deaths in 2008 (Cancer
Research UK Statistics, 2010). Improved survival is related to early FIGO stage at
diagnosis although WHO tumour grade affects survival in early stage disease (95%
for grade 1 versus 42% for grade 3) (Amant et al., LANCET 2005). The overall
prognosis is good as the disease is diagnosed at an early stage due to early
symptoms (post-menopausal bleeding). Patients should be referred to the local
Gynaecological Cancer Unit Rapid Access Clinic (RAC) under the 2-week suspected
cancer rule for assessment (including pelvic examination and transvaginal ultrasound
assessment of endometrial thickness). An endometrial biopsy and/or hysteroscopy
will be taken in selected cases (e.g. increased endometrial thickness > 5mm) either
as an outpatient or in theatre.
In England surgery for endometrial cancer is performed by gynaecologists, in local
Cancer Units in district general hospitals (lower-risk cancers i.e. low-grade,
presumed early-stage), or in regional Gynaecological Cancer Centres (by triage of
higher-risk cancers). National cancer peer review guidance and current “Improving
Outcomes Guidance” stipulates that a designated endometrial cancer surgeon
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performs the surgery in cancer units and a subspecialist Gynaecological Oncologist
in cancer centres (within mandated 31-day and 62-day cancer treatment targets).
Consequently a few cancer surgeons in the region perform the majority of the
surgery, although there are no recommendations on the method of surgery. In some
cases laparoscopic surgery may not be an option but there is no available data under
what conditions laparoscopic surgery is performed for the disease and whether there
are any specific factors influencing the choice of surgery.
Patients diagnosed with high-risk pre-malignant disease (atypical endometrial
hyperplasia) are managed as for lower-risk endometrial cancers because 17 – 52%
will be found to have endometrial cancer in the hysterectomy specimen (Pennant et
al., 2008). Surgical management for endometrial cancer includes total hysterectomy,
bilateral salpingo-oophorectomy and peritoneal washings, to stage and treat the
disease. Selected patients will have lymphadenectomy performed in the cancer
centres. Pathological information obtained will determine whether the patient requires
further treatment (radiotherapy). In some cases surgery may not be an option
(advanced disease; severe co-morbidities) and patients are offered radiotherapy,
chemotherapy or hormonal treatment. These treatments should also comply with the
31-day and 62-day UK cancer treatment standards.
About 93% of patients are diagnosed over age 50 years (post-menopausal) and
incidence peaks in the early 70’s (Cancer Research UK Statistics). As well as
increasing age, women with the disease often have severe and multiple comorbidities, including obesity (BMI > 29.9) and medical problems (e.g. diabetes,
cardiac and respiratory disease). The presence of these co-morbidities may be a
barrier to surgical management. Conventionally, the surgery has been performed via
the open or abdominal route, with a large surgical incision.
The large incision
exposes the patient to problems such as increased analgesia requirements, wound
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complications and infections, delays in mobility and prolonged hospital admission.
Vaginal surgery does not allow adequate staging procedures to be performed and
access is limited in some patients.
However, laparoscopic hysterectomy for surgical staging (Childers et al., 1993)
utilises smaller operative incisions/scars and consequently aims to reduce the length
of hospital stay and recovery time compared to open procedures. Thus many
gynaecological oncologists now use laparoscopic hysterectomy in the management
of the disease, citing the reduction in the afore-mentioned problems as the
advantage, although much of the data is retrospective or non-randomized studies
(summarized in Palomba et al., 2009). NICE has recently issued guidance regarding
laparoscopic hysterectomy for endometrial cancer (described as an “established
procedure” by specialist advisors), with recommendations for efficacy and safety,
“provided that normal arrangement are in place for clinical governance, consent and
audit” (Interventional Procedure Guidance 356, NICE, September 2010). These also
suggest that “advanced laparoscopic skills are required for this procedure and
clinicians should undergo special training and mentorship”.
In terms of efficacy there appears to be no difference in survival rates between
laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH). Meta-analysis of
five randomised-controlled trials (RCT’s) comparing LH and AH assessed survival in
three of these RCT’s (359 patients) at follow-up of a maximum of 36 months
(Palomba et al., 2009). For LH overall survival rates were 92% (169/184 patients)
compared to 88% (154/175 patients) for AH (p = 0.976). For LH disease-free survival
rates were 88% (161/184 patients); for AH 88% (154/175 patients) (p = 0.986).
Similarly a comparative study of 309 patients (non-randomised) (Cho Y-H et al.,
2007) reported similar 5-year overall survival rates of 98% for 165 patients treated by
LH and 144 patients treated by AH (p = 0.82). The 5-year progression-free survival
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rate for this group of patients was 96.5% both after LH and AH (p = 0.74). These data
suggest either procedure is effective.
As well as survival for endometrial cancer, the specialist advisers to NICE suggested
key efficacy outcomes included operative time and length of hospital stay (LOS). A
meta-analysis of four randomized controlled trials (RCT) showed laparoscopic
hysterectomy (LH) was associated with a significantly longer operating time in
minutes (OR = 53.48, 95% CI 37.28 to 69.68, p = 0.0002) (Palomba et al., 2009).
Similar findings were noted in two other RCT’s (Walker et al., 2009; Malzoni et al.,
2009). The hospital stay for LH was significantly shorter for LH compared to
abdominal hysterectomy (AH) in RCT’s of 159 and 122 patients – 2.1 vs. 5.1 days (p
< 0.01) (Malzoni et al., 2009); 7.8 days vs. 11.4 days (p = 0.001) (Tozzi et al., 2005).
In a USA Gynecologic Oncology Group (GOG) RCT of 2616 patients (1696 LH) 52%
of LH patients had LOS > 2 days vs. 94% of AH patients (p < 0.0001) (Walker et al.,
2009).
The NICE guideline has listed a number of safety issues for LH used to treat
endometrial cancer. Adverse events potentially include conversion to AH, rate of
intra-operative (e.g. haemorrhage, damage to structures) and post-operative
complications (e.g. sepsis), port-site herniation, port-metastases and vaginal vault
dehiscence (NICE 2010). It is possible that due to factors such as high BMI there
may be higher conversion rate for LH. The rates of conversion in RCT’s and nonrandomised comparative studies varied. Two RCT’s had conversion rates of 0%
(0/81) (Malzoni et al., 2009) and 8% (5/63) (Tozzi et al., 2005). Three nonrandomised comparative studies had conversion rates of 5% (10/188 Cho Y-H et al.,
2007; 11/226 Obermair et al., 2004; 4/73 Kalogiannidis et al., 2007). However, the
GOG RCT had a 26% rate of conversion from LH to open surgery (434/1682)
(Walker et al., 2009). This could have been related to the requirement for
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lymphadenectomy for all stages to comprehensively stage the disease, which is not
standard practice in the UK or other centres.
Both the GOG RCT of 2616 patients (Walker et al., 2009) and the meta-analysis of
498 patients (Palomba et al., 2009) reported no significant difference in rates of intraoperative complications for LH and AH. The former showed 9.5% (160/1682) vs.
7.6% (69/909) (p = 0.106). The latter showed 8.3% (14/169) vs. 11.7% (19/162) (p =
0.390). Although complications were not defined in the meta-analysis, the RCT of
2616 patients (Walker et al., 2009) and non-randomised comparative study of 309
patients (Cho Y-H et al., 2007) reported specific intra-operative complications for LH.
These included bowel injury (2% [37/1682] and < 1% [1/165] respectively); vascular
injury (4% [75/1682] and 1% [2/165] respectively); bladder injury (1% [21/1682 and
2/165] respectively); ureteric injury (< 1% [14/1682 and 1/165] respectively).
Both the RCT of 2616 patients (Walker et al., 2009) and the meta-analysis including
498 patients (Palomba et al., 2009) reported significantly fewer postoperative
complications after LH vs. AH (14% [240/1682] vs. 21% [191/909], p < 0.001; 17%
[27/158] vs. 32% [50/155], p = 0.007 respectively). The complications were not
defined in the meta-analysis but included sepsis, bowel obstruction or ileus, fistulae
and arrhythmia in the RCT of 2616 patients. Other reported post-operative
complications included wound dehiscence, deep vein thrombosis or pulmonary
embolus and bladder dysfunction (Cho Y-H et al., 2007).
For the five RCT’s (Fram et al., 2002; Zullo et al., 2005; Zorlu et al., 2005; Cho Y-H
et al., 2007 Zullo et al., 2009; Walker et al., 2009) included in the meta-analysis
(Palomba et al., 2009), all the surgeons eligible were capable of performing LH. For
the non-randomised comparative studies, there was no data on what influenced the
method of surgery initially. In addition LH can include different techniques such as
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laparoscopically assisted vaginal hysterectomy, total laparoscopic hysterectomy and
robotic laparoscopic hysterectomy. Not all surgeons will perform all types of
laparoscopic surgery for staging endometrial cancer.
There have been previous audits of endometrial cancer surgery in the UK (Redman,
2000; McCrum et al., 2001; Parkin et al., 2006) but none have addressed the issue of
whether laparoscopic surgery is.
Study Design
Aims of the study
To audit compliance with national and regional guidelines on the management of
newly diagnosed endometrial cancer, including surgery performed in regional cancer
network in the UK. To determine rates of laparoscopic hysterectomy and assess the
safety and efficacy of laparoscopic surgical staging in relation to outcomes in NICE
guidelines. To determine what factors influence the choice of endometrial cancer
surgical staging. Subsequently to target resources appropriately for patient
management.
Methodology
This study is a mandatory, prospective, multi-centre audit of management of
endometrial cancer within the North of England Cancer Unit, undertaken as part of
the annual audit program of the Gynaecological Cancer Site Specific Group.
1) SAMPLE
The population will be drawn from new patients diagnosed with atypical endometrial
hyperplasia (pre-malignant endometrial disease) and endometrial cancer in
Gynaecology Departments within the North of England Cancer Network over a 12month period. Annually > 100 cases of endometrial cancer are discussed at the
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regional Cancer Centre Multidisciplinary Team (MDT) based at Queen Elizabeth
Hospital, Gateshead and James Cook University Hospital, Middlesbrough. Cases of
pre-malignant disease atypical endometrial hyperplasia will be included as these are
managed in the expectation a high proportion will be diagnosed with endometrial
cancer after surgery (Pennant et al., 2008).
Participants to the questionnaires on surgical choice (APPENDIX) will include 11
Gynaecological Cancer Unit Lead Clinicians (and back-up designated endometrial
cancer surgeons at each unit) within the network; the 7 subspecialist Gynaecological
Oncologists based at the Cancer Centres (and associated subspecialty trainees). It is
expected that non-oncologists will also manage cases of atypical hyperplasia and
operate on cases where cancers will be diagnosed incidentally. Consultants
performing these procedures will also be asked to fill in the questionnaires. It is
expected that 20 – 30 gynaecologists will participate in total. As the audit is
mandatory all gynaecologists will be requested to help ensure completion of the
forms. At the end of the audit, consultants involved will be asked to fill in a further
questionnaire regarding their beliefs on what the collated outcomes will be
(APPENDIX).
Because this is a mandatory prospective audit of standard management (as part of a
recognised cancer audit program) with no change in standard patient management
or breach of confidentiality, it is expected that consent and ethical approval will not
be required although this will be confirmed with the Central Office for Research
Ethics Committees. Because there have not been previous studies on factors
influencing surgical method of staging, no calculations on sample size could be
performed. It is expected that the outcomes may influence service design in future.
The study will run with the support of the regional cancer network audit department
who will inform local pathology, audit and cancer management teams. The pathology
departments of each hospital will identify eligible cases prospectively and notify the
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Lead Clinician for Gynaecological Cancer at each hospital, who will co-ordinate and
be responsible for ensuring that the audit data (APPENDIX) is collected locally.
2) DATA COLLECTION
Data will be collected on standard proforma’s, which will be submitted to the local
hospital cancer service by the lead gynaecological cancer clinician. These will then
be forwarded to the regional cancer audit department and matched with data
collected by the central MDT’s. Data will be entered into spreadsheets for analysis.
Data will include demographic data and data on standard management (APPENDIX),
some of which can be completed with the assistance of the cancer services as it is
routinely collected.
The operating surgeon will be asked to answer the questions on choice of procedure
at the time of surgery (APPENDIX). It is expected that there will only be one case per
operating list. Further questions on efficacy and safety will be completed as well
(APPENDIX).
Outcome measures will include compliance with national management guidelines,
and comparison to the quoted NICE interventional guideline figures on safety and
efficacy for laparoscopic surgery (compared to open surgery) (NICE, 2010). The
operator’s responses to possible factors influencing their choice of surgery will also
be compared to patient characteristics and analysed to determine whether there are
any common factors. As there have been no similar studies, this will be a pilot study.
The data will be kept for long-term survival analyses.
3) DATA ANALYSIS
All data will be kept securely and will comply with the data protection act. Data will be
analysed using the Statistical Package for the Social Sciences programme. The data
will be a combination of qualitative and quantitative data, with much of the data
dichotomous yes/no answers. Audit data will be coded and then compared with
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standard guidelines to ensure that there has been compliance. The data on
complications will also be coded and compared to the figures quoted in the NICE
guidance.
Timeframe
The study will commence on 1st February 2011, assuming the agreement of the
Gynaecological Cancer Site Specific Group. Data will be reviewed after 6 months
and the audit will be completed at 12 months. Data will be stored for long-term
survival analyses.
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APPENDIX 1
The Surgical Management of Endometrial Cancer in a Regional Gynaecological
Cancer Network in the United Kingdom – Factors Influencing the Choice of Surgical
Method and a Prospective, Multi-Centre Audit of Practice and Outcomes.
QUESTIONNAIRE 1
Patient Information & characteristics (Cancer Services to provide data or
complete sections where possible)
Unique Patient Identification
NHS number
………………………
Unique Patient Identification
Unit Number
………………………
2-week rule
Y/N
(Date of referral)
………………………
Other
Y/N
(Comments)
………………………
GP surgery
Hospital at diagnosis
Date of Birth
Ethnicity
Language spoken
Referral pathway
Referral pathway
Parity
Height
Weight
BMI
Other co-morbidities
(Please specify)
Y/N
Type 1 diabetes
Y/N
Type 2 diabetes
Y/N
Hypertension
Y/N
Ischaemic
heart
Y/N
disease
Respiratory
Y/N
disease
Alzheimer’s
Y/N
disease
Other (specify)
……………………….
Previous malignancy
Y/N
(Please specify)
………………………..
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Tamoxifen use (current)
Y/N
Tamoxifen use (previous)
Y/N
HRT use (current)
Y/N
(Type if known)
HRT use (previous)
Y/N
(Type if known)
Previous
………………………..
abdominal
or
pelvic
………………………..
Y/N
surgery
(Please specify)
Midline abdominal incision
Y/N
Transverse suprapubic incision
Y/N
Previous Caesarean Section
Y/N
QUESTIONNAIRE 1
Patient Information & characteristics (CONTINUED)
Transvaginal
Y/N
Endometrial
Ultrasound scan
Date
of
positive
thickness
<
Y/N
5mm
……………………
Discussed at central MDT
Out-patient pipelle
Y/N
In-patient
Y/N
Out-patient
Y/N
In-patient or day-case
Y/N
Y/N
endometrial biopsy
Type of biopsy
Hysteroscopy
Date
of
first
……………………
treatment
First treatment
Surgery
Y/N
(if surgery, discussed
Y/N
at central MDT?)
Radiotherapy
Y/N
Chemotherapy
Y/N
Hormonal (Mirena IUS)
Y/N
Hormonal
Y/N
(progestogens)
Best supportive care
Declined
Y/N
by
Y/N
patient/family
Tumour Grade
Grade 1
Grade 2
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Grade 3
(if
applicable,
circle)
Histology subtype
Atypical
hyperplasia
Y/N
(simple or complex)
FIGO Stage (can be
completed
central
Endometrioid
Y/N
Serous
Y/N
Clear Cell
Y/N
Mucinous
Y/N
Adenosquamous
Y/N
Mixed
Y/N
Other
……………………………..
Stage 1A
Stage 1B
by
MDT)
(circle)
Stage 2
Freehand
Stage 3A
Stage 3B
Stage 3C1
Stage 3C2
Stage 4A
Stage 4B
………………………
……………………….
comments
.
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APPENDIX 2
The Surgical Management of Endometrial Cancer in a Regional Gynaecological
Cancer Network in the United Kingdom – Factors Influencing the Choice of Surgical
Method and a Prospective, Multi-Centre Audit of Practice and Outcomes.
QUESTIONNAIRE 2
Surgical management
Hospital
surgery
Date
performed
Name of consultant
Principal surgeon
Grade
of
surgeon
First assistant
Grade
assistant
ASA grade (circle)
1
2
3 4 5 6
Operation start time
Operation finish time
Uterine cavity length
Ureteric stents used
Procedures performed
Y/N
Simple Hysterectomy
Y/N
Radical Hysterectomy
Y/N
Sub-total
Y/N
hysterectomy
Vaginal
hysterectomy
Y/N
(not LAVH)
Removal both ovaries
(including
Y/N
previous
removal of ovary)
Removal both fallopian
Y/N
tubes
Peritoneal washings
Y/N
Omental biopsy
Y/N
Pelvic
Y/N
lymphadenectomy
Para-aortic
Y/N
lymphadenectomy
Initial surgical method
Abdominal (open)
14
Y/N
of
If
laparoscopic
Incision used?
Vertical
Vaginal
Y/N
Laparoscopic
Y/N
Entry method
Umbilical
Transverse
procedure (LH)
Hassan’s (open)
Palmer’s point
Direct entry
Number of abdominal
1 2 3 4 5
port sites
(Please circle)
Apart from umbilical,
Y/N
were any ports > 5mm
size?
Energy sources used
Monopolar
Y/N
Bipolar
Y/N
(all used)
Ultrasonic
(e.g.
Y/N
Harmonic)
Ligasure
Y/N
Other?
……………….
Staples for pedicles?
Y/N
Type of LH
Ovarian vessels
Y/N
ligated
Uterine vessels
Y/N
ligated
Bladder
Y/N
reflected
Date
of
discharge
(length of hospital stay)
15
Total LH
Y/N
Supra-cervical
Y/N
APPENDIX 3
Complications of surgery
INTRAOPERATIVE
For LH entry related
Y/N
injury
Primary port
Y/N
Secondary port
Y/N
For LH conversion to
Y/N
open procedure
Reason?
(e.g
adhesions,
access, etc)
Procedure-related
Bowel injury
Y/N
Vascular injury
Y/N
Bladder injury
Y/N
Ureteric injury
Y/N
injury
Obturator
nerve
Y/N
injury
Blood loss > 500 ml?
Y/N
Pre-operative Hb
Day 2 post-operative
Hb
Units
of
blood
If “Yes” number
Y/N
transfused
POST-OPERATIVE
Unscheduled
ITU
Y/N
admission
Return to theatre
Date if “Yes”?
Y/N
Reason if “Yes”?
Septicaemia
Y/N
Fistulae
Y/N
Port Hernia
Y/N
DVT
Y/N
PE
Y/N
Pelvic haematoma
Y/N
Pelvic abscess
Y/N
Type if “Yes”
16
………………………...
Ileus
Y/N
Wound dehiscence
Y/N
Vault dehiscence
Y/N
Lymphocyst
Y/N
Cardio-respiratory
Y/N
arrest
Death
Y/N
Date if “Yes”?
Port metastases
Y/N
Date if “Yes”?
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APPENDIX 4
Factors influencing choice of surgery (intention to treat basis)
(ANSWER ALL THAT YOU FEEL APPLY TO THE CASE)
1
I do not perform laparoscopic surgery for endometrial cancer
Y/N
(if “No” please do not answer remaining questions)
If you routinely perform LH but did not in this case, PLEASE
ANSWER QUESTIONS BELOW ON WHY LH WAS NOT
CONSIDERED FOR THIS PATIENT
2
High BMI
Y/N
3
High co-morbidity
Y/N
4
Anaesthetic request
Y/N
5
Lack of assistant
Y/N
6
Junior / inexperienced assistant
Y/N
7
Previous midline incision
Y/N
8
Previous major abdominal surgery
Y/N
9
History of sepsis
Y/N
10
History of adhesions
Y/N
11
Lack of operating time
Y/N
12
Restricted vaginal access
Y/N
13
Lack of uterine descent vaginally
Y/N
14
Unfamiliar / inexperienced theatre staff
Y/N
15
Reluctance of theatre staff
Y/N
18
16
Size of uterus
Y/N
17
Co-existing pathology
Y/N
18
Equipment required not available
Y/N
19
Problems with patient providing informed consent
Y/N
20
Patient requested open surgery
Y/N
21
Other reasons (please specify) ………………………………………
Which factor do you feel had the most bearing on your decision NOT to
attempt LH? Factor Number …………………………..
Freehand comments: ……………………………………………………………………
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APPENDIX 5
Letter to Gynaecological Cancer Lead Clinicians (copied to respective audit,
pathology and cancer services departments)
Dear Colleague,
I would be grateful if you would assist with the following regional audit as part of the
annual audit program for Gynaecological Cancer Site Specific Group.
The Surgical Management of Endometrial Cancer in the North of England
Gynaecological Cancer Network – Factors Influencing the Choice of Surgical
Method and a Prospective, Multi-Centre Audit of Practice and Outcomes.
The National Institute for Health & Clinical Excellence (NICE) has recently issued
guidance on laparoscopic hysterectomy as a surgical treatment for endometrial
cancer (Interventional Procedure Guidance 356, NICE, September 2010), stating that
evidence, on the efficacy and safety, is adequate to support the use of this procedure
“provided that normal arrangement are in place for clinical governance, consent and
audit”. However, this procedure is not used for all patients diagnosed with
endometrial cancer in the North of England Cancer Network (NECN), although the
reasons for this have not been assessed. The NICE guidance also suggests that
“advanced laparoscopic skills are required for this procedure and clinicians should
undergo special training and mentorship”.
As part of the annual audit program the Gynaecological Cancer Site Specific Group
(SSG) of the NECN will undertake a mandatory 12-month prospective multi-centre
audit of the treatment of cases of newly diagnosed endometrial cancer in the NECN
gynaecological cancer units and centres. As well as collecting data to assess
20
compliance with established national management guidelines, the audit will collect
data on the overall surgical management of endometrial cancer cases in the NECN.
The proposed start date is 1st February 2011.
For laparoscopic procedures the data will be analyzed to confirm whether efficacy in
the short-term and safety is comparable to the quoted figures in the NICE guidance
and differ from open surgery. Data will also be collected at the time of surgery to
assess whether there are identifiable factors that influence the choice of surgical
method in treating endometrial cancer in the NECN. By this method the
Gynaecological Cancer SSG will assess whether it can to recommend laparoscopic
treatment of the disease and justify its adoption as standard management when
possible. Resources can then be targeted as required to assist in any
recommendations.
Patients diagnosed with high-risk pre-malignant disease (atypical endometrial
hyperplasia) will also be included as they are managed as for lower-risk endometrial
cancers and 17 – 52% will be found to have endometrial cancer in the hysterectomy
specimen (Pennant et al., 2008).
As audit lead clinician for the Gynaecological Cancer SSG I would be grateful if you
would ensure the attached proforma’s are completed for each case of atypical
endometrial hyperplasia or endometrial cancer identified by your pathology
department and treated at your unit. These will be collected on a weekly basis by the
Cancer Audit Department. Where appropriate and possible some of the data will be
completed by the Gynaecological Cancer SSG (e.g. FIGO Stage). We will attempt to
assist you in any way that you require to complete the audit.
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I also enclose a preliminary questionnaire to be completed by all consultant
gynaecologists operating on these cases in your unit. This will also be circulated at
the end of the audit as well as the proforma on factors influencing surgical choice (for
your general thoughts at the end of the study period).
Please let us know of any comments you may have as the audit/study progresses.
We appreciate you assistance with this audit/study.
Yours sincerely
CONTACT NUMBERS:
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APPENDIX 6
Attached preliminary questionnaire on Endometrial Cancer (EC) Surgery
Consultant’s name
Hospital Cancer Unit/Centre
Do you perform laparoscopic surgery?
Y/N
Do you perform laparoscopic hysterectomy (LH)?
Y/N
Do you perform laparoscopic hysterectomy for (LH)
Y/N
for endometrial cancer?
If you already perform LH, would you be interested
Y/N
in additional training?
If you already perform LH, do you feel you already
comply with
the NICE Guidance on
LH
Y/N
for
endometrial cancer?
If you do NOT already perform LH, would you be
Y/N
interested in training to perform this procedure?
What barriers do you perceive to performing LH
(freehand comments)?
Do you think women should be offered the option of
Y/N
LH for endometrial cancer?
Do you think all (early-stage) EC cases should be
Y/N
performed by LH if possible?
Do you think there are (early-stage) EC cases that
Y/N
cannot be managed by LH?
(Please insert freehand comments on the above
statement)
Do your patients receive written information about
LH for endometrial cancer?
Please make any other comments that you may
have.
23
Y/N
APPENDIX 7
Now that the audit has ended what factors do you feel are most likely to have
influenced your regional colleagues choices in the type of surgery performed
for endometrial cancer/atypical hyperplasia?
(ANSWER ALL THAT YOU FEEL ARE LIKELY TO BE OF MAJOR IMPORTANCE)
1
They do not perform laparoscopic surgery for endometrial
Y/N
cancer
2
High BMI
Y/N
3
High co-morbidity
Y/N
4
Anaesthetic request
Y/N
5
Lack of assistant
Y/N
6
Junior / inexperienced assistant
Y/N
7
Previous midline incision
Y/N
8
Previous major abdominal surgery
Y/N
9
History of sepsis
Y/N
10
History of adhesions
Y/N
11
Lack of operating time
Y/N
12
Restricted vaginal access
Y/N
13
Lack of uterine descent vaginally
Y/N
14
Unfamiliar / inexperienced theatre staff
Y/N
15
Reluctance of theatre staff
Y/N
16
Size of uterus
Y/N
24
17
Co-existing pathology
Y/N
18
Equipment required not available
Y/N
19
Problems with patient providing informed consent
Y/N
20
Patient requested open surgery
Y/N
21
Other reasons (please specify) ………………………………………
Overall, which factor do you feel will have had the greatest bearing on the
decision NOT to attempt LH for the above disease? Factor Number …………….
Freehand comments: ……………………………………………………………………
25
REREFENCES
Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I.
Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505
Cancer Research UK Statistics. Uterine (womb) cancer statistics – UK, 2010
Childers JM, Brzechffa PR, Hatch KD, Surwit EA. Laparoscopically assisted
surgical
staging
(LASS)
of
endometrial
cancer.
Gynecol Oncol.
1993
Oct;51(1):33-8
Cho Y-H, Kim D-Y, Kim J-H et al. Laparoscopic management of early uterine
cancer: 10-year experience in Asan Medical Center. Gynecologic Oncology
(2007) 106: 585–90.
Fram KM. Laparoscopically assisted vaginal hysterectomy versus abdominal
hysterectomy
in
stage
I
endometrial
cancer.
International
Journal
of
Gynecological Cancer (2002) 12: 57–61.
Kalogiannidis I, Lambrechts S, Amant F et al. Laparoscopy- assisted vaginal
hysterectomy compared with abdominal hysterectomy in clinical stage I
endometrial cancer: safety, recurrence, and long-term outcome. American
Journal of Obstetrics and Gynecology (2007) 196: 248–50.
NHS National Institute for Health and Clinical Excellence. Laparoscopic
hysterectomy (including laparoscopic total hysterectomy and laparoscopically
assisted vaginal hysterectomy) for endometrial cancer. Interventional procedure
guidance 356, Issue date: September 2010.
Malzoni M, Tinelli R, Cosentino F et al. Total laparoscopic hysterectomy versus
abdominal hysterectomy with lymphadenectomy for early- stage endometrial
cancer: a prospective randomized study. Gynecologic Oncology (2009) 112:
126–33.
26
McCrum A, Howe K, Weeks J, Kirkpatrick A, Murdoch J. A prospective regional
audit of surgical management of endometrial cancer in the South and West of
England. J Obstet Gynaecol. 2001 Nov;21(6):605-9.
Obermair A, Manolitsas T, Leung Y et al. Total laparoscopic hysterectomy for
endometrial cancer: patterns of recurrence and survival. Gynecologic Oncology
(2004) 92: 789–93.
Palomba S, Falbo A, Mocciaro R et al. Laparoscopic treatment for endometrial
cancer: a meta-analysis of randomized controlled trials (RCTs). Gynecologic
Oncology (2009) 112: 415–21.
Palomba S, Falbo A, Zullo F. Updating of a recent meta-analysis of randomized
controlled trials to assess the safety and the efficacy of the laparoscopic surgery
for treating early stage endometrial cancer. Gynecologic Oncology (2009) 114:
135–9.
Parkin DE, Warraich Q, Fleming DJ, Chew GK, Cruickshank ME. An audit of the
quality of endometrial cancer care in a specialised unit. Scott Med J. 2006
May;51(2):22-4
Pennant S, Manek S & Kehoe S. Endometrial atypical hyperplasia and
subsequent diagnosis of endometrial cancer: a retrospective audit and literature
review. J Obstet Gynaecol, 2008; 28(6): 632 -33
Redman CW. An audit of the management of uterine malignancy within the West
Midlands. West Midlands Gynaecological Oncology Group. BJOG. 2000
Apr;107(4):552-5
Tozzi R, Malur S, Koehler C et al. Laparoscopy versus laparotomy in endometrial
cancer: first analysis of survival of a randomized prospective study. Journal of
Minimally Invasive Gynecology (2005)12: 130–6.
Walker JL, Piedmonte MR, Spirtos NM et al. Laparoscopy compared with
laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic
Oncology Group Study LAP2. Journal of Clinical Oncology (2009) 27: 5331–6.
27
Zullo F, Palomba S, Russo T et al. A prospective randomized comparison
between laparoscopic and laparotomic approaches in women with early stage
endometrial cancer: a focus on the quality of life. American Journal of Obstetrics
and Gynecology (2005) 193: 1344–52.
Zorlu CG, Simsek T, Ari ES. Laparoscopy or laparotomy for the management of
endometrial cancer. Journal of the Society of Laparoendoscopic Surgeons (2005)
9: 442–6.
Zullo F, Palomba S, Falbo A et al. Laparoscopic surgery vs laparotomy for early
stage endometrial cancer: long-term data of a randomized controlled trial.
American Journal of Obstetrics and Gynecology (2009) 200: 296–99.
28