Hysterectomy - A Regional Intervention Study (HYSTERI)

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.

Study Overview

• Status: Recruiting
• Conditions: Benign Hysterectomy; Postoperative Recovery; Preoperative Planning
• Intervention / Treatment: Other: Intiensified structured perioperative information

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 Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Preben Kjölhede, MD PhD; Phone Number: +46101030000; Email: preben.kjolhede@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Recruiting
    • University Hospital
    • Contact: Preben Kjölhede, Professor; Phone Number: +46101030000; Email: preben.kjolhede@liu.se
  • Norrköping, Sweden, 58185
    • Recruiting
    • Vrinnevisjukhuset
    • Contact: Lollo Makdessi Björklund, MD; Phone Number: +46101030000; Email: lollo.makdessi.bjorklund@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensified preoperative 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.	Other: Intiensified structured perioperative information; 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.
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Study Chair: Preben Kjölhede, MD PhD, University Hospital, Linköing; Study Chair: Lollo Makdessi, MD, Vrinnevi Hospital, Norrköping

Publications and helpful links

General Publications

• Björkström LM, Wodlin NB, Nilsson L, Kjølhede 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HYSTERI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No