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Completed

NCT Number: NCT01526668

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.

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Key information

Conditions

Hysterectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Höglandshospital, Eksjö, Jonkopings Län, Sweden

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About this study

Contact sponsor if detailed information is requested.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Follow-up strategy

Behavioral

Comparison of different follow-up strategies

No contact after discharge

Behavioral

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. Consumption of analgesic

    Time frame: Six weeks

    Total amount of opioids and non-opioids from surgery to six weeks postoperatively

  3. Complications related to operation

    Time frame: Six weeks

    From surgery to six weeks postoperatively

  4. Health economy

    Time frame: Up to 1 years

    Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work

  5. Development of chronic pelvic pain

    Time frame: One year

    Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively

  6. Duration of sick-leave

    Time frame: Up to one year

    Time from day of surgery to return to work at same level as preoperatively

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Acronym: POSTHYSTREC

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2012
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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