Outpatient HysterectomyLHNCT02933047
Laparoscopic Hysterectomy - Outpatient Versus Inpatient Regimen
A study testing Total laparoscopic hysterectomy in people with Outpatient Hysterectomy, run by University of Aarhus.
Trial summary
Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of… Read more about this study
- Who is it for?
- Ages 18 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Outpatient Hysterectomy
- What is being tested?
- Total laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
- Additional surgery is allowed in the gynecological area.
- BMI and working status is NOT exclusion criteria's.
Who cannot join
- Unable to read and write Danish to answer questionnaires.
- Unable to walk to carry a pedometer.
About this study
Official title: Laparoscopic Hysterectomy - A Randomized Controlled Trial on Outpatient Versus Inpatient Regimen
Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient care to day case surgery might influence readmission rates and postoperative physical activity. No data are available on the current length of sick leave in Danish patients after hysterectomy, and the effects of outpatient surgery on this parameter are difficult to predict. A randomized controlled trial of LH performed as an outpatient procedure compared with today's inpatient standard will provide a firm platform for future planning of routine treatment of patients with need of hysterectomy for benign indications.
Read the detailed description
Hysterectomy is the most frequent gynecological operation world wide and the indication is often benign. The women are healthy and young with a median age below 50 years. In Denmark, hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day. Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus whether VH or LH should be recommended as first choice but LH is gaining more and more acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting. Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting remains an open question. A detailed analysis of data from a Norwegian study indicates that patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a decrease in patient's satisfaction would present a significant problem, and a randomized controlled study of sufficient size with focus on this aspect is therefore needed.
Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based guidelines and no firm data are available on the relation between outpatient treatment and sick leave in gynecology.
This randomized controlled study attempt to examine outpatient LH and patient satisfaction and related subject as readmissions and complications, time to return to work, physical activity in the recuperation period and an overall socioeconomic calculation of the costs of LH in an in- and outpatient setting.
- Conditions
- Outpatient Hysterectomy
- Being tested
- Total laparoscopic hysterectomy
- Keywords
- Hysterectomy, Patient satisfaction, Rehabilitation, Laparoscopy, Return to work, Exercise
- Medical subject headings
- Patient Satisfaction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laparoscopic hysterectomyProcedure or surgery
Total laparoscopic hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Outpatient LH | Active comparator | Patients in the intervention group are discharged within 6 to 8 hours after total laparoscopic hysterectomy. Receives: Procedure: Total laparoscopic hysterectomy |
| Inpatient LH | Placebo comparator | Patients in the control group follow regular hospitalization and are discharged within 24 hours after total laparoscopic hysterectomy. Receives: Procedure: Total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with length of stay after total laparoscopic hysterectomy.
Difference in satisfaction with length of stay between intervention group and placebo measured on a visual analogue scale from 0 to 10 with 10 being most satisfied and presented on an international unit scale.
Measured: 2 weeks after surgery
Patient satisfaction and quality of life
The difference in patient satisfaction between inpatient and outpatient laparoscopic hysterectomy 4 weeks from surgery measured by the European Quality of life questionnaire in 5 dimensions (EQ5D) and presented as an index number.
Measured: 4 weeks from date of surgery
Secondary outcomes (3)
Incidence and pattern of complications and readmissions for in- and outpatient LH.
Number and type of complications found in medical records. Outcome will be presented as odds ratios and compared using chi2 measurement.
Measured: 4 weeks from the date of surgery
Physical activity in the recovery period after in- and outpatient LH.
Daily walking distance in steps per day. Data will be presented as repeated measurement and the groups are compared by pairwise comparison.
Measured: 4 weeks from the date of surgery
Return to work after in- and outpatient LH.
Date of return to work after surgery. The sick-leave is 14 days. When the sick-leave is more than 14 days it will be part of a socioeconomic analysis of lost work capacity and time spend on consultations. The difference between the groups will be measured in QALY's (Quality adjusted life year) and monetary values.
Measured: 6 month from the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outpatient HysterectomyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ulla J. Christiansen, MD, Principal investigator, Arhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933047
- Sponsor's protocol ID
- 5711674
- Other IDs
- 1-16-02-212-13
- Acronym
- LH
- Status last verified
- Apr 2016
- First submitted
- 21 Oct 2013
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Christiansen UJ, Kruse AR, Olesen PG, Lauszus FF, Kesmodel US, Forman A. Outpatient vs inpatient total laparoscopic hysterectomy: A randomized controlled trial. Acta Obstet Gynecol Scand. 2019 Nov;98(11):1420-1428. doi: 10.1111/aogs.13670. Epub 2019 Jul 15.
PubMed 31148146
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hysterectomy - A Randomized Controlled Trial on Outpatient Versus Inpatient Regimen
- ClinicalTrials.gov ID
- NCT02933047
- Acronym / sponsor ID
- LH / 5711674
- Conditions
- Outpatient Hysterectomy
- Keywords
- Hysterectomy, Patient satisfaction, Rehabilitation, Laparoscopy, Return to work, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient care to day case surgery might influence readmission rates and postoperative physical activity. No data are available on the current length of sick leave in Danish patients after hysterectomy, and the effects of outpatient surgery on this parameter are difficult to predict. A randomized controlled trial of LH performed as an outpatient procedure compared with today's inpatient standard will provide a firm platform for future planning of routine treatment of patients with need of hysterectomy for benign indications.
Detailed description
Hysterectomy is the most frequent gynecological operation world wide and the indication is often benign. The women are healthy and young with a median age below 50 years. In Denmark, hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day. Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus whether VH or LH should be recommended as first choice but LH is gaining more and more acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting. Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting remains an open question. A detailed analysis of data from a Norwegian study indicates that patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a decrease in patient's satisfaction would present a significant problem, and a randomized controlled study of sufficient size with focus on this aspect is therefore needed.
Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based guidelines and no firm data are available on the relation between outpatient treatment and sick leave in gynecology.
This randomized controlled study attempt to examine outpatient LH and patient satisfaction and related subject as readmissions and complications, time to return to work, physical activity in the recuperation period and an overall socioeconomic calculation of the costs of LH in an in- and outpatient setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient LH | Active comparator | Procedure: Total laparoscopic hysterectomyPatients in the intervention group are discharged within 6 to 8 hours after total laparoscopic hysterectomy. |
| Inpatient LH | Placebo comparator | Procedure: Total laparoscopic hysterectomyPatients in the control group follow regular hospitalization and are discharged within 24 hours after total laparoscopic hysterectomy. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
- Additional surgery is allowed in the gynecological area.
- BMI and working status is NOT exclusion criteria's.
Key exclusion criteria (2 listed)
- Unable to read and write Danish to answer questionnaires.
- Unable to walk to carry a pedometer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total laparoscopic hysterectomy | Procedure or surgery | Outpatient LH |
| Total laparoscopic hysterectomy | Procedure or surgery | Inpatient LH |
Primary outcome
Satisfaction with length of stay after total laparoscopic hysterectomy.
Time frame: 2 weeks after surgery
Difference in satisfaction with length of stay between intervention group and placebo measured on a visual analogue scale from 0 to 10 with 10 being most satisfied and presented on an international unit scale.
Patient satisfaction and quality of life
Time frame: 4 weeks from date of surgery
The difference in patient satisfaction between inpatient and outpatient laparoscopic hysterectomy 4 weeks from surgery measured by the European Quality of life questionnaire in 5 dimensions (EQ5D) and presented as an index number.
3 secondary outcomes
Incidence and pattern of complications and readmissions for in- and outpatient LH.
Time frame: 4 weeks from the date of surgery
Physical activity in the recovery period after in- and outpatient LH.
Time frame: 4 weeks from the date of surgery
Return to work after in- and outpatient LH.
Time frame: 6 month from the date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Derived from this study: PubMed 31148146Christiansen UJ, Kruse AR, Olesen PG, Lauszus FF, Kesmodel US, Forman A. Outpatient vs inpatient total laparoscopic hysterectomy: A randomized controlled trial. Acta Obstet Gynecol Scand. 2019 Nov;98(11):1420-1428. doi: 10.1111/aogs.13670. Epub 2019 Jul 15.
- Individual participant dataSharing planned: No
Related trials for Outpatient Hysterectomy
RecruitingObservational study
Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery
to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla J. Christiansen, MD principal investigator
Arhus University
Questions about this trial
What is this clinical trial studying?
A study testing Total laparoscopic hysterectomy in people with Outpatient Hysterectomy, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with length of stay after total laparoscopic hysterectomy. (time frame: 2 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.