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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01526668
First received: January 27, 2012
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hysterectomy
Genital Diseases, Female
Pain
Behavioral: Follow-up strategy
Behavioral: No contact after discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    The Euroqol questionnaire form (EQ-5D) and Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.


Secondary Outcome Measures:
  • Postoperative symptoms [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Selfreported symptoms in the Swedish Postoperative Symptom Questionnaire. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.

  • Consumption of analgesic [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Total amount of opioids and non-opioids from surgery to six weeks postoperatively

  • Complications related to operation [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    From surgery to six weeks postoperatively

  • Health economy [ Time Frame: Up to 1 years ] [ Designated as safety issue: No ]
    Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work

  • Development of chronic pelvic pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively

  • Duration of sick-leave [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Time from day of surgery to return to work at same level as preoperatively


Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Contact sponsor if detailed information is requested.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526668

Contacts
Contact: Preben Kjolhede, MD, PhD +46101030000 ext 3187 Preben.Kjolhede@lio.se
Contact: Ninnie Borendal Wodlin, MD, PhD +46101030000 ext 3133 Ninnie.Borendal.Wodlin@lio.se

Locations
Sweden
Department of Obstetrics and Gynecology, Höglandshospital Recruiting
Eksjo, Jonkopings län, Sweden, 57533
Contact: Tomasz Stypa, MD    +4638135000    Tomasz.Stypa@lj.se   
Principal Investigator: Tomasz Stypa, MD         
Department of Obstetrics and Gynecology, Ryhov Central Hospital Recruiting
Jonkoping, Jonkopings län, Sweden, 551 85
Contact: Laila Falknas, MD    +4636321000    Laila.Falknas@lj.se   
Principal Investigator: Laila Falknas, MD         
Department of Obstetrics and Gynecology Recruiting
Varnamo, Jonkopings Län, Sweden, 331 85
Contact: Christina Gunnervik, MD    +46270697000    Christina.Gunnervik@lj.se   
Principal Investigator: Christina Gunnervik, MD         
Department of Obstetrics and Gynecology, University Hospital Recruiting
Linkoping, Ostergotland, Sweden, 58185
Contact: Preben Kjolhede, MD, PhD    +46101030000 ext 3187    Preben.Kjolhede@lio.se   
Contact: Ninnie Borendal Wodlin, MD, PhD    +46101030000 ext 3133    Ninnie.Borendal.Wodlin@lio.se   
Principal Investigator: Preben Kjolhede, MD, PhD         
Sub-Investigator: Ninnie Borendal Wodlin, MD, PhD         
Sub-Investigator: Gulnara Kassymova, MD         
Sub-Investigator: Peter Lukas, MD         
Department of Obstetrics and Gynecology, Vrinnevi Hospital Recruiting
Norrkoping, Ostergotland, Sweden, 60779
Contact: Leif Hidmark, MD    +46101030000    Leif.Hidmark@lio.se   
Principal Investigator: Leif Hidmark, MD         
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Study Chair: Preben Kjolhede, MD, PhD Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, 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
  More Information

No publications provided

Responsible Party: Preben Kjolhede, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01526668     History of Changes
Other Study ID Numbers: POSTHYSTREC
Study First Received: January 27, 2012
Last Updated: May 27, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Benign gynecological disease
Surgery
Postoperative follow-up strategy
Pain threshold
Chronic pelvic pain
[E04.950.300.399]
[C13.351.500]
[F02.463.593.710.560]
[N02.421.585.722.700]
Postoperative Care

Additional relevant MeSH terms:
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 25, 2014