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Procedural sedation for hysteroscopic myomectomy: costeffectiveness and patient preference


- candidate number22696
- NTR NumberNTR5357
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2015
- Secondary IDs843002603  ZonMW
- Public TitleProcedural sedation for hysteroscopic myomectomy: costeffectiveness and patient preference
- Scientific TitleProcedural sedation for hysteroscopic myomectomy: costeffectiveness and patient preference
- ACRONYM
- hypothesisHysteroscopic myomectomies are performed in the majority of Dutch hospitals. The number of procedures for submucosal type 0 or I myomas between 1-3 cm performed in the operating room is estimated to be 3000 per year. Hysteroscopic myomectomy is currently performed in daycare under general anesthesia. A considerable cost reduction is expected when procedural sedation with propofol is applied. Procedural sedation is used for a wide variety of interventional procedures in multiple settings outside the operation room. In gynaecology, the use of procedural sedation has become more popular since technical and instrumental improvements have significantly increased the feasibility and acceptability of hysteroscopy in outpatient settings. The shift from surgery in an operating theatre to an office-based setting and shorter hospital stay -day care versus outpatient care- are the major contributing factors to the expected cost reduction. We expect higher patient satisfaction, as both hospital stay and time-to-work are shorter and side effects such as nausea are reduced. However, both safety and effectiveness – including the necessity for re-intervention due to incomplete resection- have not yet been fully evaluated. In summary, we expect comparable effectiveness of the procedure in a safe and patient friendly environment whilst achieving a significant cost reduction.
- Healt Condition(s) or Problem(s) studiedHysterectomy, Myoma, Cost-effectiveness , Sedation, Patient preference
- Inclusion criteria- Women aged between 18 and 55 years
- Symptomatic type 0 or I submucous myomas
- Maximum diameter of submucous myomas: 3 cm
- American Society of Anesthesiologist class 1 or 2
- Exclusion criteria- Inability to understand Dutch or English
- Clotting disorders
- Severe anemia (Hb under 5.0 mmol/l).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2015
- planned closingdate
- Target number of participants184
- Interventions- Procedural sedation and analgesia in an outpatient setting: According to guidelines from the Health Care Inspectorate (IGZ) and Dutch Institute for Healthcare Improvement (CBO) non-anesthesiologist administered Propofol (NAAP) sedation is given and monitored by a qualified sedation practitioner. The patient will be assessed by the sedation practitioner immediately prior to surgery on the basis of a pre-operative questionnaire. Non-invasive blood pressure, electrocardiogram and oxygen saturation are measured before vascular access is obtained. Propofol and alfentanil are used for procedural sedation. Hysteroscopic resection is performed by an experienced surgeon by standard procedure in an office-based setting. Patients are observed after the procedure by qualified personnel and discharged as soon as all the discharge criteria are met, normally within 1 to 1.5 hours.

General anesthesia: General anesthesia can be volatile based or total intravenously, with the use of a laryngeal mask. Postoperative, patients will be observed in the recovery room and discharged home from the clinic when all the discharge criteria are met.

The way hysteroscopic resection is performed under general anesthesia does not differ from the way it is performed under procedural sedation.
- Primary outcomePrimary outcome will be the percentage of complete resections as judged by the surgeon during the procedure and based on ultrasonography 6 weeks postoperatively by an independent gynecologist or ultrasonographer blinded for the surgery outcome.
- Secondary outcomeSecondary outcomes are cost effectiveness, pain, menstrual blood loss (PBAC score), patient preference, quality of life as assessed by questionnaires: EuroQoL (EQ-5D-5L), Recovery Index (RI-10) and Uterine Fibroid Symptoms – Quality of Life questionnaire (UFS-QoL), return to daily activities/work, hospitalization, (post)operative complications, re-interventions.
- TimepointsBaseline: UFS-QoL, EQ-5D-5L,PBAC score
During the procedure:
- completeness of resection as judged by surgeon
- surgical complications
- anesthesiologic complications (desaturation, airway obstruction, dysrhythmias, blood pressure drops, ECG alterations)
- operating time
- intravasation/fluid deficit
- recovery time (time from end of procedure until completely awake and communicative)
- use of pain medication and dose
- pain intensity measured by VAS scores
- duration of hospitalization (hours)
After the procedure:
24 hours: one questionnaire including: side effects nausea and vomiting, pain (VAS score), RI-10, EQ-5D-5L
2 weeks: one questionnaire including: RI-10, EQ-5D-5L
6 weeks: Transvaginal ultrasonography for assessment of completeness of resection. One questionnaire including RI-10, EQ-5D-5L. Completion of diary with absence from work/daily activities, use of analgesics, number of doctor’s visits. Costs.
3 months: PBAC score, UFS-QoL, costs
6 months: PBAC sore and one questionnaire including: UFS-QoL, EQ-5D-5L, costs
12 months: EQ-5D-5L, costs
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Julia van der Meulen
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator Maxima Medisch Centrum Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsThe principal investigator will publish the results of the study in a peer reviewed medical journal as soon as appropriate.
- Brief summary
- Main changes (audit trail)
- RECORD11-aug-2015 - 25-aug-2015


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