Image

Hysterectomy - A Regional Intervention Study

Recruiting
18 - 55 years of age
Female
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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.

Study details

Benign Hysterectomy, Postoperative Recovery, Preoperative Planning

NCT05255120

University Hospital, Linkoeping

20 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.