Benign HysterectomyHYSTERINCT05255120
Hysterectomy - A Regional Intervention Study
A study testing Intiensified structured perioperative information in people with Benign Hysterectomy and Postoperative Recovery, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial summary
Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences in preoperative information, planning of surgery and surgical technique. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Benign Hysterectomy, Postoperative Recovery, Preoperative Planning
- What is being tested?
- Intiensified structured perioperative information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Sep 2020to 1 Oct 2024
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18 - 55 years old.
- Women undergoing hysterectomy for benign indication.
- Women with ASA 1 - 3.
- Women who understand and can express themselves in Swedish.
- Women who, by signing "Informed Consent", agree to participate in the study after written and oral information.
- Women who participate and respond to the surveys in the GynOp register.
- Women who have access to an I-phone, smartphone, computer or tablet and who can use the study-specific mobile application. (Does not apply to sub-study 1).
Who cannot join
- Women where both ovaries are removed during the operation.
- Women undergoing hysterectomy for prolapse indication.
- Women undergoing hysterectomy for cancer prophylactic indication.
- Women undergoing hysterectomy for gender reassignment purposes.
- Women with intellectual disabilities to such an extent that they can not fill in the relevant questionnaires etc. or if they do not understand the meaning of participating in the study or where there may be ethical doubts about the patient's participation in the study.
- Women who have a mental illness of such severity that the doctor in charge considers it inappropriate for the patient to be included in the study.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital
Linköping, 58185
Vrinnevisjukhuset
Norrköping, 58185
About this study
Official title: The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study
Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences in preoperative information, planning of surgery and surgical technique. A structured approach including the use of mobile phone technology can possibly improve patient information and patient involvement. Our purpose is to to evaluate whether systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication.
Read the detailed description
Background Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences between clinics in Sweden in the proportion of hysterectomies conducted using minimally invasive surgery. There is no uniformity in the planning of surgery. Patient-reported outcome measures, such as satisfaction and postoperatively unexpected symptoms, are important in assessing the outcome of surgery. Patient-reported measurements are, besides other factors, dependent on preoperative information. Mobile phone technology can possibly improve patient information and patient involvement.
Purpose
To evaluate whether a systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication. The work consists of three parts with the following purposes:
Sub-study 1: To evaluate the effect of a preoperative algorithm for determining the most appropriate method of hysterectomy on the proportion undergoing surgery as a minimally invasive procedure and on the frequency of complications.
Sub-study 2: To compare patient-reported outcome measures, including unexpected symptoms, recovery, and satisfaction, in women who receive systematic preoperative information from specially trained staff and a mobile application with targeted education on the procedure, with women who receive information according to normal routines.
Sub-study 3: To investigate how women experience digitized information via a mobile application in connection with surgery.
Participating centers Departments of obstetrics and gynecology at the hospitals in Norrköping, Jönköping, Eksjö, Värnamo, Västervik, Kalmar and Växjö.
Schedule The study starts in September 2020. Recruitment of patients is planned to take two years.
- Being tested
- Intiensified structured perioperative information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intiensified structured perioperative informationOther
The doctor takes a medical history and examines the patient according to regular routines, but uses the algorithm as support in deciding on the surgical method. After the doctor's visit, the patient must see a research nurse to receive the intensified preoperative information about hysterectomy. This information is designed according to a checklist. The patient can also download a mobile application. The study-specific mobile application (app) contains information about hysterectomy. The information is structured in three parts - Before the Operation, At the Hospital and After the Operation. A timeline describes the activities and events that occur before, around and after the operation. Within each section there are several information links, with eg checklists.
| Study group | Role | What they receive |
|---|---|---|
| Intensified preoperative information | Experimental | The patient participating in the intervention group is evaluated preoperatively based on an algorithm. This information is designed according to a checklist which includes how the procedure is performed, rules of conduct in connection with and after the procedure and what the patient can expect after surgery. Receives: Other: Intiensified structured perioperative information |
| Control group | No intervention | The patient who participates in the control group receives information about participation in the study as a control, ie without information about the intervention. The patient will then be planned for the procedure according to current, local routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected postoperative symtoms
Proportion of patients with unexpected symptoms.
Measured: Up to one year postoperatively
Proportion minimally invasive hysterectomy
Proportion of women undergoing hysterectomy as a minimally invasive procedure
Measured: Retrospecive data 5 years before study start until completion of prospective study
Secondary outcomes (5)
Complication
Numbers of and types of patient reported complications
Measured: Up to one year postoperatively
Lenght of stay
Hospital length of stay in connection with surgery
Measured: Day of surgery until discharge from hospital pre- and during the intervention
Sick leave
return to work measured as actual sick leave length
Measured: Day of discharge from hospital after surgery until return to normal work, maximal one year
Recovery
time to normal daily activity (ADL)
Measured: Day of surgery until normal ADL, maximal one year
Health related quality of life
Measured with EuroQol EQ-5D-3L health index comprising of two parts. Part A Scale -0.5941 to 1. A higher number indicates better quality of life. Part B. EuroQol visual analoque scale EQ-VAS. Scale 0-100. A higher number indicates better quality of life
Measured: Preoperatively up to one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start4 Sep 2020
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
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 Benign HysterectomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preben Kjolhede, MD, professor, University Hospital, Linkoeping
- Investigators
- Preben Kjölhede, MD PhD, Study chair, University Hospital, LinköingLollo Makdessi, MD, Study chair, Vrinnevi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255120
- Sponsor's protocol ID
- HYSTERI
- Acronym
- HYSTERI
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjorkstrom LM, Wodlin NB, Nilsson L, Kjolhede P. The Impact of Preoperative Assessment and Planning on the Outcome of Benign Hysterectomy - a Systematic Review. Geburtshilfe Frauenheilkd. 2021 Feb;81(2):200-213. doi: 10.1055/a-1263-0811. Epub 2021 Feb 8.
PubMed 33574624
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT05255120
- Acronym / sponsor ID
- HYSTERI / HYSTERI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- 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.
Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences in preoperative information, planning of surgery and surgical technique. A structured approach including the use of mobile phone technology can possibly improve patient information and patient involvement. Our purpose is to to evaluate whether systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication.
Detailed description
Background Approximately 4,000 procedures with hysterectomy for benign indication are performed annually in Sweden. There are large differences between clinics in Sweden in the proportion of hysterectomies conducted using minimally invasive surgery. There is no uniformity in the planning of surgery. Patient-reported outcome measures, such as satisfaction and postoperatively unexpected symptoms, are important in assessing the outcome of surgery. Patient-reported measurements are, besides other factors, dependent on preoperative information. Mobile phone technology can possibly improve patient information and patient involvement.
Purpose
To evaluate whether a systematic preoperative preparation improves the outcome of elective hysterectomy on benign indication. The work consists of three parts with the following purposes:
Sub-study 1: To evaluate the effect of a preoperative algorithm for determining the most appropriate method of hysterectomy on the proportion undergoing surgery as a minimally invasive procedure and on the frequency of complications.
Sub-study 2: To compare patient-reported outcome measures, including unexpected symptoms, recovery, and satisfaction, in women who receive systematic preoperative information from specially trained staff and a mobile application with targeted education on the procedure, with women who receive information according to normal routines.
Sub-study 3: To investigate how women experience digitized information via a mobile application in connection with surgery.
Participating centers Departments of obstetrics and gynecology at the hospitals in Norrköping, Jönköping, Eksjö, Värnamo, Västervik, Kalmar and Växjö.
Schedule The study starts in September 2020. Recruitment of patients is planned to take two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified preoperative information | Experimental | Other: Intiensified structured perioperative informationThe patient participating in the intervention group is evaluated preoperatively based on an algorithm. This information is designed according to a checklist which includes how the procedure is performed, rules of conduct in connection with and after the procedure and what the patient can expect after surgery. |
| Control group | No intervention | –The patient who participates in the control group receives information about participation in the study as a control, ie without information about the intervention. The patient will then be planned for the procedure according to current, local routines. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women 18 - 55 years old.
- Women undergoing hysterectomy for benign indication.
- Women with ASA 1 - 3.
- Women who understand and can express themselves in Swedish.
- Women who, by signing "Informed Consent", agree to participate in the study after written and oral information.
Key exclusion criteria (6 listed)
- Women where both ovaries are removed during the operation.
- Women undergoing hysterectomy for prolapse indication.
- Women undergoing hysterectomy for cancer prophylactic indication.
- Women undergoing hysterectomy for gender reassignment purposes.
- Women with intellectual disabilities to such an extent that they can not fill in the relevant questionnaires etc. or if they do not understand the meaning of participating in the study or where there may be ethical doubts about the patient's participation in the study.
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 |
|---|---|---|
| Intiensified structured perioperative informationThe doctor takes a medical history and examines the patient according to regular routines, but uses the algorithm as support in deciding on the surgical method. After the doctor's visit, the patient must see a research nurse to receive the intensified preoperative information about hysterectomy. This information is designed according to a checklist. The patient can also download a mobile application. The study-specific mobile application (app) contains information about hysterectomy. The information is structured in three parts - Before the Operation, At the Hospital and After the Operation. A timeline describes the activities and events that occur before, around and after the operation. Within each section there are several information links, with eg checklists. | Other | Intensified preoperative information |
Primary outcome
Unexpected postoperative symtoms
Time frame: Up to one year postoperatively
Proportion of patients with unexpected symptoms.
Proportion minimally invasive hysterectomy
Time frame: Retrospecive data 5 years before study start until completion of prospective study
Proportion of women undergoing hysterectomy as a minimally invasive procedure
5 secondary outcomes
Complication
Time frame: Up to one year postoperatively
Lenght of stay
Time frame: Day of surgery until discharge from hospital pre- and during the intervention
Sick leave
Time frame: Day of discharge from hospital after surgery until return to normal work, maximal one year
Recovery
Time frame: Day of surgery until normal ADL, maximal one year
Health related quality of life
Time frame: Preoperatively up to one year postoperatively
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 16 Dec 2024.
- Background: PubMed 33574624Bjorkstrom LM, Wodlin NB, Nilsson L, Kjolhede P. The Impact of Preoperative Assessment and Planning on the Outcome of Benign Hysterectomy - a Systematic Review. Geburtshilfe Frauenheilkd. 2021 Feb;81(2):200-213. doi: 10.1055/a-1263-0811. Epub 2021 Feb 8.
- Individual participant dataSharing planned: No
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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.
Preben Kjölhede, MD PhD study chair
University Hospital, Linköing
Lollo Makdessi, MD study chair
Vrinnevi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intiensified structured perioperative information in people with Benign Hysterectomy and Postoperative Recovery, run by University Hospital, Linkoeping at 2 sites in Sweden.
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 7 inclusion and 6 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Unexpected postoperative symtoms (time frame: Up to one year postoperatively). 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 NCT05255120, 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 16 Dec 2024.