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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01510496
Other study ID # GENDOLCAT
Secondary ID
Status Completed
Phase N/A
First received December 23, 2011
Last updated December 29, 2015
Start date January 2009
Est. completion date July 2014

Study information

Verified date December 2015
Source Fundacion IMIM
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

The treatment of postoperative pain continues to be inadequate in the investigators practice setting.

Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 3979
Est. completion date July 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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), hysterectomy, thoracotomy (men).

Exclusion Criteria:

- Patients aged less than 18 years,

- Patients requiring reoperation because of surgical complications.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Inguinal herniorraphy.
Inguinal herniorraphy (non laparoscopic).
Hysterectomy.
Hysterectomy: Vaginal and abdominal.
Thoracotomy .
Thoracotomy (non laparoscopic).

Locations

Country Name City State
Spain Hospital Municipal de Badalona Badalona Barcelona
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clínic i Provincial de Barcelona Barcelona
Spain Hospital de l'Esperança Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital del Sant Boi Barcelona
Spain Hospital Sagrat Cor Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital de San Bernabé Berga Barcelona
Spain Hospital Universitari Doctor Josep Trueta de Girona Girona
Spain Hospital de Granollers Granollers Barcelona
Spain Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Hospital Santa Maria Lleida
Spain Hospital General de Manresa Manresa Barcelona
Spain Hospital de Mataro Mataro Barcelona
Spain Hospital Sant Joan de Reus Reus Tarragona
Spain Hospital Parc Tauli Sabadell Barcelona
Spain Hospital de Santa Caterina Salt Girona
Spain Hospital Mutua de Terrassa Terrassa Barcelona
Spain Hospital Universitari Mutua de Terrassa Terrassa Barcelona
Spain Hospital Clínico de Valencia Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitari de la Fe Valencia
Spain Hospital de Viladecans Viladecans Barcelona
Spain Hospital Lluís Alcanyís de Xàtiva Xàtiva València

Sponsors (1)

Lead Sponsor Collaborator
Fundacion IMIM

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of chronic postsurgical pain. After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone. After 3 and 12 months of surgery. No
Secondary Predictive factors of chronic postsurgical pain. Preoperative (psychological factors, preoperative pain, pharmacologic treatment) intraoperative (surgical technic, type of anaestesia) and postoperative(posoperative pain, surgical complications and treatment of postoperative pain). After 3 and 12 months of surgery. Yes
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