HysterectomyPOSTHYSTRECNCT01526668

Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

A study testing Follow-up strategy and No contact after discharge in people with Hysterectomy and Genital Diseases, Female, run by University Hospital, Linkoeping at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: Hysterectomy, Genital Diseases, Female, Pain
What is being tested?: Follow-up strategy and No contact after discharge
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 525 participants
Where: 5 sitesSweden
Study dates: 11 Oct 2011to 31 Jan 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Sweden5 sites

Department of Obstetrics and Gynecology, Höglandshospital
Eksjö, Jonkopings Län, 57533
Department of Obstetrics and Gynecology, Ryhov Central Hospital
Jönköping, Jonkopings Län, 551 85
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, 58185
Department of Obstetrics and Gynecology, Vrinnevi Hospital
Norrköping, Östergötland County, 60779
Department of Obstetrics and Gynecology
Värnamo, Jonkopings Län, 331 85

Other trials in Sweden

About this study

Official title: 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.

Read the detailed description

Contact sponsor if detailed information is requested.

Conditions: Hysterectomy, Genital Diseases, Female, Pain
Being tested: Follow-up strategy, No contact after discharge
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
Medical subject headings: Genital Diseases, Female, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Follow-up strategyBehavioural
Comparison of different follow-up strategies
No contact after dischargeBehavioural

Study groups in NCT01526668
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Follow-up strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Six weeks

Secondary outcomes (6)

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.
Measured: Six weeks
Consumption of analgesic
Total amount of opioids and non-opioids from surgery to six weeks postoperatively
Measured: Six weeks
Complications related to operation
From surgery to six weeks postoperatively
Measured: Six weeks
Health economy
Direct and indirect costs, quality adjusted life years (QALYs). From surgery to return to work
Measured: Up to 1 years
Development of chronic pelvic pain
Development of chronic pelvic pain one year postoperatively among women with no pelvic pain preoperatively
Measured: One year
Duration of sick-leave
Time from day of surgery to return to work at same level as preoperatively
Measured: Up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201131 Jan 2018

First posted6 Feb 2012 (estimated)
Study start11 Oct 2011
Primary completion31 Jan 2018
Study completion31 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HysterectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01526668
Sponsor's protocol ID: POSTHYSTREC
Acronym: POSTHYSTREC
Status last verified: Feb 2022
First submitted: 27 Jan 2012
Last updated: 7 Feb 2022
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 40314809
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.
PubMed 39707275
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.
PubMed 38558946
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.
PubMed 36050542
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.
PubMed 33232628

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
ClinicalTrials.gov ID: NCT01526668
Acronym / sponsor ID: POSTHYSTREC / POSTHYSTREC
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]
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: University Hospital, LinkoepingUniversity, hospital or other
Study start: 11 Oct 2011 (actual)
Primary completion: 31 Jan 2018 (actual)
Study completion: 31 Jan 2018 (actual)
First posted: 6 Feb 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Contact sponsor if detailed information is requested.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
No contact after discharge	Active comparator	Behavioral: No contact after dischargeIn 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.
Single telephone contact	Active comparator	Behavioral: Follow-up strategyIn 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.
Telephone contacts regularly	Active comparator	Behavioral: Follow-up strategyIn 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.
Telephone contact using CBT-inspired strategy	Active comparator	Behavioral: Follow-up strategyIn 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.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Follow-up strategyComparison of different follow-up strategies	Behavioural	Single telephone contact, Telephone contact using CBT-inspired strategy, Telephone contacts regularly
No contact after discharge	Behavioural	No contact after discharge

Primary outcome

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.
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

6 secondary outcomes

Postoperative symptoms
Time frame: Six weeks
Consumption of analgesic
Time frame: Six weeks
Complications related to operation
Time frame: Six weeks
Health economy
Time frame: Up to 1 years
Development of chronic pelvic pain
Time frame: One year
Duration of sick-leave
Time frame: Up to one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
Derived from this study: PubMed 40314809Kassymova 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.
Derived from this study: PubMed 39707275Lukas 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.
Derived from this study: PubMed 38558946Kassymova 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.
Derived from this study: PubMed 36050542Kassymova 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.
Derived from this study: PubMed 33232628Kassymova 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.

Related trials for Hysterectomy

Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Preben Kjolhede, MD, PhD study chair

Department of Obstetrics and Gynecology, University Hospital, 58185 Linkoping, Sweden

Ninnie Borendal Wodlin, MD, PhD study chair

Department of Obstetrics and Gynecology, University Hospital, S-58185 Linkoping, Sweden

Lena Nilsson, MD, PhD study chair

Department of Anesthesiology, University Hospital, S-58185 Linkoping, Sweden

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Follow-up strategy and No contact after discharge in people with Hysterectomy and Genital Diseases, Female, run by University Hospital, Linkoeping at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life as measured by the EQ-5D health index (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01526668, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.