Hysterectomy - A Regional Intervention Study

Not Applicable

Completed

• Conditions: Benign Hysterectomy; Preoperative Planning; Postoperative Recovery
• Interventions: Other: Intiensified structured perioperative information

• Registration Number: NCT05255120
• Lead Sponsor: University Hospital, Linkoeping

Brief 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. 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 Timeline

• Study Start: 2020-09-04
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensified preoperative information	Intiensified structured perioperative information	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.

Primary Outcome Measures

Name	Time	Method
Unexpected postoperative symtoms	Up to one year postoperatively	Proportion of patients with unexpected symptoms.
Proportion minimally invasive hysterectomy	Retrospecive data 5 years before study start until completion of prospective study	Proportion of women undergoing hysterectomy as a minimally invasive procedure

Secondary Outcome Measures

Name	Time	Method
Complication	Up to one year postoperatively	Numbers of and types of patient reported complications
Recovery	Day of surgery until normal ADL, maximal one year	time to normal daily activity (ADL)
Lenght of stay	Day of surgery until discharge from hospital pre- and during the intervention	Hospital length of stay in connection with surgery
Health related quality of life	Preoperatively up to one year postoperatively	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
Sick leave	Day of discharge from hospital after surgery until return to normal work, maximal one year	return to work measured as actual sick leave length

Trial Locations

Locations (2)

University Hospital; 🇸🇪 Linköping, Sweden

Vrinnevisjukhuset; 🇸🇪 Norrköping, Sweden