Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy (POSTHYSTREC)

February 4, 2022 updated by: Preben Kjolhede, MD, professor, University Hospital, Linkoeping

A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

The purpose of the study is to investigate the effect of four different follow-up strategies on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions. Furthermore the investigators aim to examine associations between preoperative thresholds for pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain after benign hysterectomy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Contact sponsor if detailed information is requested.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
525

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Jonkopings Län
      • Eksjo, Jonkopings Län, Sweden, 57533
        • Department of Obstetrics and Gynecology, Höglandshospital
      • Jonkoping, Jonkopings Län, Sweden, 551 85
        • Department of Obstetrics and Gynecology, Ryhov Central Hospital
      • Varnamo, Jonkopings Län, Sweden, 331 85
        • Department of Obstetrics and Gynecology
    • Ostergotland
      • Linkoping, Ostergotland, Sweden, 58185
        • Department of Obstetrics and Gynecology, University Hospital
      • Norrkoping, Ostergotland, Sweden, 60779
        • Department of Obstetrics and Gynecology, Vrinnevi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between 18 and 60 years of age.
  • Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia).
  • Women who understand and speak Swedish fluently.
  • Women who gives signed informed consent to participate in the study.
  • Women who have access to a telephone and/or internet.

Exclusion Criteria:

  • Women where the hysterectomy is carried out in association with surgery for genital prolapse
  • Women with genital malignancies (does not include cervical dysplasia).
  • Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant.
  • Women with previous bilateral salpingooophorectomy.
  • Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual.
  • Women who are mentally disabled to a degree so she cannot complete the forms in the study or understand the tenor of the participation or it is considered doubtful from an ethical point of view to participate.
  • Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable.
  • Women with current drug or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: No contact after discharge
In Arm A: The patient do not have planned contacts with the study nurse or doctor after discharge. All patients are seen by the study nurse six weeks postoperatively.
Behavioral: No contact after discharge
Active Comparator: Single telephone contact
In Arm B: The patient has one planned telephone contact with the study nurse the day after discharge. All patients are seen by the study nurse six weeks postoperatively.
Behavioral: Follow-up strategy
Comparison of different follow-up strategies
Active Comparator: Telephone contacts regularly
In Arm C: The patient has planned telephone contacts with the study nurse the day after discharge and then once weekly until the six weeks follow-up visit postoperatively.
Behavioral: Follow-up strategy
Comparison of different follow-up strategies
Active Comparator: Telephone contact using CBT-inspired strategy
In Arm C: The patient has planned telephone contacts with the study nurse the day after discharge and then once weekly until the six weeks follow-up visit postoperatively. At these telephone contacts the study nurse uses a cognitive behavior therapy (CBT)-inspired strategy in counselling and support.
Behavioral: Follow-up strategy
Comparison of different follow-up strategies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life as measured by the EQ-5D health index
Time Frame: Six weeks
The Euroqol questionnaire form (EQ-5D) are used for assessing the quality of life. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.
Six weeks
Quality of life as measured by the SF-36 sub scale scores
Time Frame: Six weeks
The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks
Six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative symptoms
Time Frame: Six weeks
Selfreported symptoms in the Swedish Postoperative Symptom Questionnaire. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.
Six weeks
Consumption of analgesic
Time Frame: Six weeks
Total amount of opioids and non-opioids from surgery to six weeks postoperatively
Six weeks
Complications related to operation
Time Frame: Six weeks
From surgery to six weeks postoperatively
Six weeks
Health economy
Time Frame: Up to 1 years
Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work
Up to 1 years
Development of chronic pelvic pain
Time Frame: One year
Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively
One year
Duration of sick-leave
Time Frame: Up to one year
Time from day of surgery to return to work at same level as preoperatively
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Linkoeping

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Preben Kjölhede, MD, PhD, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
  • Study Chair: Ninnie Borendal Wodlin, MD, PhD, Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
  • Study Chair: Lena Nilsson, MD, PhD, Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden
  • Study Chair: Gunilla Sydsjo, PhD, Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
  • Study Chair: Gulnara Kassymova, MD, Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
  • Study Chair: Peter Lukas, MD, Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
  • Study Chair: Björn Gerdle, MD, PhD, Pain and Rehabilitation Center, University Hospital, 581 85 Linkoping, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POSTHYSTREC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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