Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy (POSTHYSTREC)

University Hospital, Linkoeping

Status: Completed

Conditions: Hysterectomy; Pain; Genital Diseases, Female

Treatments: Behavioral: No contact after discharge; Behavioral: Follow-up strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01526668

POSTHYSTREC

Details and patient eligibility

About

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.

Full description

Contact sponsor if detailed information is requested.

Enrollment: 525 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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525 participants in 4 patient groups

No contact after discharge

Active Comparator group

Description:

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.

Treatment:

Behavioral: No contact after discharge

Single telephone contact

Active Comparator group

Description:

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.

Treatment:

Behavioral: Follow-up strategy

Telephone contacts regularly

Active Comparator group

Description:

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.

Treatment:

Behavioral: Follow-up strategy

Telephone contact using CBT-inspired strategy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Follow-up strategy