PERIoperative Holistic RIsk Factor SCreening in the Prevention of Persistent Pain

NCT ID: NCT05526976

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2024-03-06

Brief Summary

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Assessment and management for improved wellbeing after elective surgery (PERISCOP³E-Care) Diagnostic assessment tool evaluation and cut-off determination for participation in a transmural perioperative care program

Detailed Description

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Adult patients (≥ 18y) who are planned to undergo an elective surgery at the University Hospital Antwerp, will be invited to participate. After signing the informed consent, they will be asked to complete questionnaires (PERISCOP3E-care; Kalkman \& modified-Althaus, DN4, HADS, Stait-trait, NRS, MPIn EQ-5D-5L) that involve screening of the risk to develop persistend postoperative pain (PPSP).

The questionnaires will be completed via a survey link to the RedCap platform. Invites will be send out via the patient's e-mail.

Demograpic data and relevant medical history, surgery history, concomitant medication will be registered.

one month and three months post surgery the patients will be contacted to identicate if they developed PPSP. They will also be asked to complete quesionnaires (MPI, HADS, Stai-Trait, NRS, MPI, DN4). Based on this info, the cut-off value will be defined for the preoperative questionnaire. Analysis will be done for the sensitivity and specificity of the questionnaires.

Conditions

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Pain, Chronic Post-Surgical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PERISCOPE-care

Patients with planned elective surgery will be asked to complete the PERISCOP3E-Care questionnaire (modified-Althaus \& Kalkman, DN4, HADS, Stait-trait, NRS, MPI, EQ-5D-5L) preoperative. One month and three months post op the patients will be contacted to check if they developed persistend postoperative pain and they will also complete questionnaires (DN4, HADS, Stait-trait, NRS, MPI and EQ-5D-5L).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patiënts (≥ 18 year)
* planned elective surgery @ University Hospital Antwerp

Exclusion Criteria

* incapacitated
* cognitive dificit that makes it impossible to complete the questionnaires
* language barrier
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davina Wildemeersch

Role: PRINCIPAL_INVESTIGATOR

Staff Member

Locations

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UZA

Edegem, Antwerp, Belgium

Site Status

University Hospital Antwerp

Antwerp, , Belgium

Site Status

Countries

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Belgium

References

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Wildemeersch D, Wauters E, Roelant E, Verhaegen I, De Clerck GR, Dankerlui R, Saldien V, Hans GH. A Novel Presurgical Risk Prediction Model for Chronic Post-Surgical Pain in Adults Undergoing Surgical Procedures: Development and Internal Validation of the P4-Prevoque Questionnaire [PERISCOPE Trial]. J Pain Res. 2025 Jul 5;18:3415-3428. doi: 10.2147/JPR.S525692. eCollection 2025.

Reference Type DERIVED
PMID: 40636548 (View on PubMed)

Wildemeersch D, Meeus I, Wauters E, Vanlommel L, Roelant E, Dankerlui R, Saldien V, Vandervelde L, Verhaegen I, Hans GH. Evaluating the Predictive Value of a Short Preoperative Holistic Risk Factor Screening Questionnaire in Preventing Persistent Pain in Elective Adult Surgery: Study Protocol for a Prospective Observational Pragmatic Trial [PERISCOPE]. J Pain Res. 2023 Dec 13;16:4281-4287. doi: 10.2147/JPR.S439824. eCollection 2023.

Reference Type DERIVED
PMID: 38107366 (View on PubMed)

Other Identifiers

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EDGE002575

Identifier Type: -

Identifier Source: org_study_id

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