NCT04546594

Brief Summary

The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 23, 2025

Status Verified

September 1, 2025

Enrollment Period

5.2 years

First QC Date

September 4, 2020

Last Update Submit

December 17, 2025

Conditions

Keywords

Pain,perioperative painepidemiologypredictive factors

Outcome Measures

Primary Outcomes (1)

  • Descriptive analysis of the typology of pain in patients needing surgery.

    The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing

    Baseline

Secondary Outcomes (5)

  • Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.

    follow-up over a period of five years during post-operative or pain medical consultation

  • Pain Catastrophizing Scale (PCS) according to pain

    Baseline and follow-up over a period of five years during post-operative or pain medical consultation

  • Hospital Anxiety Depression scale (HAD) according to pain

    Baseline and follow-up over a period of five years during post-operative or pain medical consultation

  • EQD5 according to pain

    Baseline and follow-up over a period of five years during post-operative or pain medical consultation

  • Identification of factors predictive of acute or chronic pain.

    Baseline and at three months, six months, one year

Study Arms (3)

Orthopedic surgery

Thoracic surgery

Gynecological surgery

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients consulting at the university hospital of Lille and needing orthopedic, thoracic, gynecological surgical management with or without painful symptoms and chronic painful patients in the context of organ pathologies.

You may qualify if:

  • Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration

You may not qualify if:

  • Age under 18 years old
  • Non-communicating patient
  • Patient does not understand French
  • Patient without social protection
  • Patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal DiseasesPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Michel Wattier, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 14, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 23, 2025

Record last verified: 2025-09