Validation of Predictive Scale of Chronic Postsurgical Pain

December 9, 2016 updated by: Antonio Montes, Parc de Salut Mar

Prospective External Validation of a Predictive Scale of Chronic Postsurgical Pain

To asses the precision of a score to predict chronic post surgical pain in patients undergoing inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy. Prospective multicenter cohort study in 21 hospital in spain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1040

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital de la Vall d'Hebron
      • Barcelona, Spain, 08026
        • Hospital de Sant Pau
      • Barcelona, Spain, 08035
        • Hospital de Sant Rafael
      • Bizkaia, Spain, 48960
        • Hospital de Galdakao
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hopsital Gregorio Marañón
      • Sevilla, Spain, 41014
        • Hospital Nuestra Senora de Valme
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Valencia, Spain, 46800
        • Hospital Lluis Alcanyís de Xàtiva
      • Valladolid, Spain, 47003
        • Hospital de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Tries i Pujol
      • Badalona, Barcelona, Spain, 08911
        • Hospital de Badalona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital De Bellvitge
      • Mataro, Barcelona, Spain, 08304
        • Hospital de Mataró
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
      • Terrassa, Barcelona, Spain, 08227
        • Hospital de Terrassa
    • Bizcaia
      • Baracaldo, Bizcaia, Spain, 48903
        • Hospital de Cruces
    • Palma
      • Palma de Mallorca, Palma, Spain, 07120
        • Hospital Son Espases
      • Palma de Mallorca, Palma, Spain, 07198
        • Hospital Son Llatzer
    • Valencia
      • Alicante, Valencia, Spain, 03010
        • Hospital General de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All spanish patients who undergo scheduled surgery of one of the following types:

inguinal herniorrhaphy, abdominal hysterectomy, vaginal hysterectomy, thoracotomy.

Description

Inclusion Criteria:

  • Patients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), abdominal hysterectomy, vaginal hysterectomy and thoracotomy (men)

Exclusion Criteria:

  • Patients aged less than 18 years,
  • Patients requiring reoperation because of surgical complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic post-surgical pain patients
Patients scheduled for differents types of surgery (inguinal, hernia repair, abdominal hysterectomy, vaginal hysterectomy, and thoracotomy).
Procedure: Inguinal hernia repair
Procedure: Abdominal hysterectomy
Procedure: Vaginal hysterectomy
Procedure: Thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12).
Time Frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
GENDOLCAT scale punctuations (composed by 6 items: type of surgery, age, pain in area of surgery, pain in other localisations, physical component of SF12 and mental component of SF12) to identify patients that could develop chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy.
After evaluation of chronic postsurgical pain 4th month after the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal rating scale
Time Frame: After evaluation of chronic postsurgical pain 4th month after the end of surgery
Prevalence of chronic post surgical pain after inguinal hernia repair, abdominal hysterectomy, vaginal hysterectomy and thoracotomy will be assessed by verbal rating scale.
After evaluation of chronic postsurgical pain 4th month after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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