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

Completed

Conditions

Intervention / Treatment

Detailed Description

Contact sponsor if detailed information is requested.

Study Type

Interventional

Enrollment (Actual)

525

Phase

  • 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

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
Intervention / Treatment
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

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

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

University Hospital, Linkoeping

Investigators

  • 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)

October 11, 2011

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID 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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