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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02991287
Other study ID # PI16/00279
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 5, 2016
Last updated December 9, 2016
Start date February 2017
Est. completion date December 2019

Study information

Verified date December 2016
Source Parc de Salut Mar
Contact Antonio Montes, PhD
Phone 0034932483000
Email amontes@parcdesalutmar.cat
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1040
Est. completion date December 2019
Est. primary completion date February 2019
Accepts healthy volunteers Accepts Healthy Volunteers
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), abdominal hysterectomy, vaginal hysterectomy and 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


Related Conditions & MeSH terms


Intervention

Procedure:
Inguinal hernia repair

Abdominal hysterectomy

Vaginal hysterectomy

Thoracotomy


Locations

Country Name City State
Spain Hospital General de Alicante Alicante Valencia
Spain Hospital de Badalona Badalona Barcelona
Spain Hospital Germans Tries i Pujol Badalona Barcelona
Spain Hospital de Cruces Baracaldo Bizcaia
Spain Hospital de la Vall d'Hebrón Barcelona
Spain Hospital de Sant Pau Barcelona
Spain Hospital de Sant Rafael Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital de Galdakao Bizkaia
Spain Hospital de Bellvitge Hospitalet de Llobregat Barcelona
Spain Hopsital Gregorio Marañon Madrid
Spain Hospital 12 de Octubre Madrid
Spain Hospital de Mataró Mataro Barcelona
Spain Hospital Son Espases Palma de Mallorca Palma
Spain Hospital Son Llatzer Palma de Mallorca Palma
Spain Hospital Parc Taulí Sabadell Barcelona
Spain Hospital Nuestra Señora de Valme Sevilla
Spain Hospital de Terrassa Terrassa Barcelona
Spain Hospital Lluís Alcanyís de Xàtiva Valencia
Spain Hospital Universitario La Fe Valencia
Spain Hospital de Valladolid Valladolid

Sponsors (1)

Lead Sponsor Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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 No
Secondary Verbal rating scale 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 No
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