Clinical trial NCT01526668: Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
Official title: A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Genital Diseases, Female
Pain
Keywords: 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
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 525
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Contact sponsor if detailed information is requested.

Eligibility 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.

Primary outcomes:
measure: Quality of life as measured by the EQ-5D health index
timeFrame: Six weeks
measure: Quality of life as measured by the SF-36 sub scale scores
timeFrame: Six weeks
Secondary outcomes:
measure: Postoperative symptoms
timeFrame: Six weeks
measure: Consumption of analgesic
timeFrame: Six weeks
measure: Complications related to operation
timeFrame: Six weeks
measure: Health economy
timeFrame: Up to 1 years
measure: Development of chronic pelvic pain
timeFrame: One year
measure: Duration of sick-leave
timeFrame: Up to one year
Other outcomes:
Locations:
city: Eksjo
country: Sweden
facility: Department of Obstetrics and Gynecology, Höglandshospital
state: Jonkopings Län
city: Jonkoping
country: Sweden
facility: Department of Obstetrics and Gynecology, Ryhov Central Hospital
state: Jonkopings Län
city: Varnamo
country: Sweden
facility: Department of Obstetrics and Gynecology
state: Jonkopings Län
city: Linkoping
country: Sweden
facility: Department of Obstetrics and Gynecology, University Hospital
state: Ostergotland
city: Norrkoping
country: Sweden
facility: Department of Obstetrics and Gynecology, Vrinnevi Hospital
state: Ostergotland
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, Sweden
name: Preben Kjolhede, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
name: Ninnie Borendal Wodlin, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden
name: Lena Nilsson, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
name: Gunilla Sydsjo, PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
name: Gulnara Kassymova, MD
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden
name: Peter Lukas, MD
role: STUDY_CHAIR
affiliation: Pain and Rehabilitation Center, University Hospital, 581 85 Linkoping, Sweden
name: Björn Gerdle, MD, PhD
role: STUDY_CHAIR
References:
citation: Kassymova G, Sydsjo G, Wodlin NB, Nilsson L, Kjolhede P. Effect of nurse-led telephone follow-up on postoperative symptoms and analgesics consumption after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial. Arch Gynecol Obstet. 2023 Feb;307(2):459-471. doi: 10.1007/s00404-022-06722-x. Epub 2022 Sep 2.
citation: Kassymova G, Sydsjo G, Borendal Wodlin N, Nilsson L, Kjolhede P. The Effect of Follow-Up Contact on Recovery After Benign Hysterectomy: A Randomized, Single-Blinded, Four-Arm, Controlled Multicenter Trial. J Womens Health (Larchmt). 2021 Jun;30(6):872-881. doi: 10.1089/jwh.2020.8752. Epub 2020 Nov 24.