Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

Pain Clinical Trial

— POSTHYSTREC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526668
• Other study ID #: POSTHYSTREC
• Status: Completed
• Phase: N/A
• Start date: October 11, 2011
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2022
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Contact sponsor if detailed information is requested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Hysterectomy
• Pain

Intervention

Behavioral:
• Follow-up strategy
Comparison of different follow-up strategies
• No contact after discharge

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Höglandshospital	Eksjo	Jonkopings Län
Sweden	Department of Obstetrics and Gynecology, Ryhov Central Hospital	Jonkoping	Jonkopings Län
Sweden	Department of Obstetrics and Gynecology, University Hospital	Linkoping	Ostergotland
Sweden	Department of Obstetrics and Gynecology, Vrinnevi Hospital	Norrkoping	Ostergotland
Sweden	Department of Obstetrics and Gynecology	Varnamo	Jonkopings Län

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as measured by the EQ-5D health index	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
Primary	Quality of life as measured by the SF-36 sub scale scores	The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks	Six weeks
Secondary	Postoperative symptoms	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
Secondary	Consumption of analgesic	Total amount of opioids and non-opioids from surgery to six weeks postoperatively	Six weeks
Secondary	Complications related to operation	From surgery to six weeks postoperatively	Six weeks
Secondary	Health economy	Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work	Up to 1 years
Secondary	Development of chronic pelvic pain	Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively	One year
Secondary	Duration of sick-leave	Time from day of surgery to return to work at same level as preoperatively	Up to one year