Hysterectomy - A Regional Intervention Study (HYSTERI)

University Hospital, Linkoeping

Status: Completed

Conditions: Postoperative Recovery; Preoperative Planning; Benign Hysterectomy

Treatments: Other: Intiensified structured perioperative information

Study type: Interventional

Funder types: Other

Identifiers

NCT05255120

HYSTERI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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).

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Intensified preoperative information

Experimental group

Description:

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.

Treatment:

Other: Intiensified structured perioperative information

Control group

No Intervention group

Description:

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.