What is the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an endometrioma when compared to treatment with medication?
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful pain reduction (- 30% reduction of pain on numeric rating scale
[NRS]) after 6 months.
Secondary outcome
o Successful pain reduction after 12 and 18 months measured by the numeric
rating scale as described above;
o Quality of life: measured by the EuroQoL-5D-5L and EHP30 questionnaires.
This will be used to calculate QALY and productivity loss;
o Affective symptoms: measured by the GAD-7 and PHQ-9 questionnaires.
o Costs effectiveness: health care costs, patients and family costs and
productivity costs measured from a societal perspective using internet
questionnaires based on the iMCQ and iPCQ;
o Recurrence rate: recurrence of either pain symptoms (measured on the NRS
as described above) and the endometrioma itself (measured
with ultrasound);
o Need of adjuvant medication (analgesics and/or hormones) after surgery. This
information will be provided from the patients medical file by a local
investigator or research nurse;
o Ovarian reserve: measured by blood test (AMH levels) and ultrasound (AFC).
AMH will only be measured in the randomised controlled trial;
o Adjuvant surgery: rate of adjuvant surgery after treatment with medication
for endometrioma. Adjuvant surgery will be offered in case of insufficient pain
relief 6 months after treatment with medication;
o Budget impact: calculated at the end of the trial by comparing total costs
from the group treated with medication and the group treated by surgery.
o Best Worst Score: BWS scores are calculated using the following formula:
**number of times attribute selected as best** - ** number of times attribute
selected as worst**/number of times attribute appeared. BWS scores range from
-1.0 to 1.0, where -1.0 reflects the worst (attribute selected as worst in
every question) and 1.0 reflects the best (attribute selected as best in every
question), a score of 0 means that the attribute was selected as best and as
worst an equal number of times.
Background summary
Two therapeutic strategies are available for the treatment of endometrioma,
including medication (analgesia and/or hormones) and surgical treatment.
Evidence suggests that both treatment with medication and surgery are effective
in reducing pain. However, there are no randomized studies that compared
surgery to medication. This forces women with endometrioma and physicians to
take decisions in uncertainty about the benefits, risks and cost-effectiveness
of surgery in direct comparison with treatment with medication.
Study objective
What is the effectiveness and cost-effectiveness of surgical treatment of women
suffering from pain due to an endometrioma when compared to treatment with
medication?
Study design
Multicenter prospective cohort trial. In the beginning this was a randomized
controlled trial with cost-effectiveness analysis and preference study.
Non-randomized women, who had a preference for one of the treatments, would be
treated according to their preference and asked for inclusion in a prospective
cohort.
Intervention
Surgical treatment compared to treatment with medication (hormone
therapy/analgesics) for endometriosis.
Study burden and risks
Both medical treatment and surgical treatment are part of the standard care for
endometriomas. Therefore no additional risks are expected. Patients who
participate in this study might undergo surgery earlier than they would during
the current standard care.
Possible disadvantage of surgery:
One of the risks of surgery is recurrence of the cyst, causing relapse of
symptoms. Furthermore, some studies showed that healthy ovarian tissue is
accidentally removed during surgery which may cause a loss of ovarian reserve.
There is a small risk that the whole ovary has to be removed. As for every
abdominal surgery, there is always a small risk of infection, bleeding and
damage to intestines or urinary tract.
Possible disadvantage of treatment with medicines:
Treatment with medicines can cause side effects. The severity depends on the
individual. The effect of medical treatment may be temporarily and women may
experience insufficient pain relief or exacerbations of pain symptoms. Due to
these disadvantages, surgery may still be necessary.
Most study visits will be combined with regular care visits and activities in
order to reduce the burden of participation in this study. In regular care,
patients treated with medication will have follow-up four times a year.
Therefore, patients receiving treatment with medication during this study, will
have no extra study visits. However patients treated by surgery in regular care
only have follow-up at 6 weeks after treatment. Therefore patients treated with
surgery in this study will get three extra study visits (at 6, 12 and 18
months).
• T0: Start of study
o After counselling and informed consent baseline characteristics will be
measured (regular care, no additional visit).
o Regular care activities: defining the level op pain (on numeric rating
scale, NRS), ultrasound including antral follicle count (AFC).
o Additional study activities: Quality of life and affective symptom
questionnaires (EQ5D-5L, EHP30, GAD-7, PHQ-9), blood collection for
anti-mullerian hormone(AMH).
• T1: 6 weeks follow-up:
o Regular care activities: NRS
o Additional study activities: Quality of life and affective symptom
questionnaires.
• T2: 6 months follow-up
o NRS
o ultrasound, AFC
o AMH
o Quality of life, affective symptom and cost questionnaires.
In case of insufficient pain relief for patients in the medication group,
adjuvant surgical treatment is offered.
• T3: 12 months follow-up:
o NRS
o ultrasound, AFC
o AMH
o Quality of life, affective symptom and cost questionnaires.
• T4: 18 months follow up:
o NRS
o ultrasound, AFC
o AMH
o Quality of life, affective symptom and cost questionnaires.
AMH is not measured in the Cohort-study.
Preference study:
o Filling in questionnaires: 45 minutes
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
- Premenopausal woman aged >= 18 years;
- Pain symptoms (dysmenorrhoea, pelvic pain or dyspareunia);
- Endometrioma >= 3 cm (confirmed by ultrasound or MRI).
Exclusion criteria
- Women with signs of deep endometriosis (by physical examination, ultrasound
or MRI);
- Women who are not able or willing to provide written informed consent;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 7689 |
| CCMO | NL67922.015.18 |
| OMON | NL-OMON22624 |