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

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ClinicalTrials.gov Identifier: NCT01526668
Recruitment Status : Unknown
Verified February 2016 by Preben Kjolhede, MD, professor, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
First Posted : February 6, 2012
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, MD, professor, University Hospital, Linkoeping

January 27, 2012
February 6, 2012
February 23, 2016
October 2011
December 2016   (Final data collection date for primary outcome measure)
Quality of life [ Time Frame: Six weeks ]
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.
Quality of life [ Time Frame: Six weeks ]
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.
Complete list of historical versions of study NCT01526668 on ClinicalTrials.gov Archive Site
  • 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.
  • Consumption of analgesic [ Time Frame: Six weeks ]
    Total amount of opioids and non-opioids from surgery to six weeks postoperatively
  • Complications related to operation [ Time Frame: Six weeks ]
    From surgery to six weeks postoperatively
  • Health economy [ Time Frame: Up to 1 years ]
    Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work
  • Development of chronic pelvic pain [ Time Frame: One year ]
    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 ]
    Time from day of surgery to return to work at same level as preoperatively
  • 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.
  • Consumption of analgesic [ Time Frame: Six weeks ]
    Total amount of opiods and non-opioids from surgery to six weeks postoperatively
  • Complications related to operation [ Time Frame: Six weeks ]
    From surgery to six weeks postoperatively
  • Health economy [ Time Frame: Up to 1 years ]
    Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work
  • Development of chronic pelvic pain [ Time Frame: One year ]
    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 ]
    Time from day of surgery to return to work at same level as preoperatively
Not Provided
Not Provided
 
Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
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.
Contact sponsor if detailed information is requested.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Hysterectomy
  • Genital Diseases, Female
  • Pain
  • Behavioral: Follow-up strategy
    Comparison of different follow-up strategies
  • Behavioral: No contact after discharge
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Follow-up strategy
  • 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.
    Intervention: Behavioral: Follow-up strategy
  • 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.
    Intervention: Behavioral: Follow-up strategy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
600
Same as current
December 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01526668
POSTHYSTREC
Yes
Not Provided
Not Provided
Preben Kjolhede, MD, professor, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
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
University Hospital, Linkoeping
February 2016

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