NCT05255120

Hysterectomy - A Regional Intervention Study

The Effect of Systematic Preoperative Preparation on the Outcome of Benign Hysterectomy: a Prospective Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Hysterectomy
• Postoperative Recovery
• Preoperative Planning

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-04
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-02-24
• Last updated: 2024-12-16

Locations

2 sites across 1 country: Sweden