NCT01526668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

6.3 years

First QC Date

January 27, 2012

Last Update Submit

February 4, 2022

Conditions

HysterectomyGenital Diseases, FemalePain

Keywords

Benign gynecological diseaseSurgeryPostoperative follow-up strategyPain thresholdChronic pelvic pain[E04.950.300.399][C13.351.500][F02.463.593.710.560][N02.421.585.722.700]Postoperative Care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Postoperative symptoms

    Six weeks

  • Consumption of analgesic

    Six weeks

  • Complications related to operation

    Six weeks

  • Health economy

    Up to 1 years

  • Development of chronic pelvic pain

    One year

  • +1 more secondary outcomes

Study Arms (4)

No contact after discharge

ACTIVE COMPARATOR

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

Single telephone contact

ACTIVE COMPARATOR

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

Telephone contacts regularly

ACTIVE COMPARATOR

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

Telephone contact using CBT-inspired strategy

ACTIVE COMPARATOR

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

Interventions

Follow-up strategyBEHAVIORAL

Comparison of different follow-up strategies

Single telephone contactTelephone contact using CBT-inspired strategyTelephone contacts regularly
No contact after dischargeBEHAVIORAL
No contact after discharge

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Obstetrics and Gynecology, Höglandshospital

Eksjö, Jonkopings Län, 57533, Sweden

Location

Department of Obstetrics and Gynecology, Ryhov Central Hospital

Jönköping, Jonkopings Län, 551 85, Sweden

Location

Department of Obstetrics and Gynecology

Värnamo, Jonkopings Län, 331 85, Sweden

Location

Department of Obstetrics and Gynecology, University Hospital

Linköping, Östergötland County, 58185, Sweden

Location

Department of Obstetrics and Gynecology, Vrinnevi Hospital

Norrköping, Östergötland County, 60779, Sweden

Location

Related Publications (5)

  • Kassymova G, Davidson T, Sydsjo G, Wodlin NB, Nilsson L, Kjolhede P. Cost analysis of nurse-lead telephone follow-ups after benign hysterectomy: a randomized, single-blinded, four-arm, controlled multicenter trial. Arch Gynecol Obstet. 2025 Aug;312(2):515-523. doi: 10.1007/s00404-025-08035-1. Epub 2025 May 2.

    PMID: 40314809DERIVED

  • Lukas P, Nilsson L, Wodlin NB, Arendt-Nielsen L, Kjolhede P. Changes in spatial bodily pain distribution one year after benign hysterectomy with emphasis on prevalence and risk factors for de novo and persistent pelvic pain- a prospective longitudinal multicenter study. BMC Womens Health. 2024 Dec 20;24(1):644. doi: 10.1186/s12905-024-03474-5.

    PMID: 39707275DERIVED

  • Kassymova G, Sydsjo G, Borendal Wodlin N, Nilsson L, Kjolhede P. The Impact of Symptoms of Depression, Anxiety, and Low Stress-Coping Capacity on the Effects of Telephone Follow-Up on Recovery Measures After Hysterectomy. Womens Health Rep (New Rochelle). 2024 Mar 27;5(1):304-318. doi: 10.1089/whr.2023.0045. eCollection 2024.

    PMID: 38558946DERIVED

  • 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.

    PMID: 36050542DERIVED

  • 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.

    PMID: 33232628DERIVED

MeSH Terms

Conditions

Genital Diseases, FemalePain

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 6, 2012

Study Start

October 11, 2011

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations

SE(5)