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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03602664
Other study ID # LUA-74206
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2018
Est. completion date April 2020

Study information

Verified date August 2018
Source Sahlgrenska University Hospital, Sweden
Contact Stefan Lundin, MD PhD
Phone +46 31 3428112
Email stefan.lundin@gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A questionaire specifically developed using in depth interviews with patients that has undergone surgery has been developed. This questionaire will be used for longterm follow in patients undergoing thoracic surgery. 200 patients will be asked to fill in this questionaire preoperatively as well as 3 and 12 months after surgery to assess symptomburden after surgery with specific aim to study postoperative pain as well as other physical, mental and cognitive problems that may affect the patient and their daily activities, health, return to work, family life and economy.


Description:

In Sweden around 400 000 patients under go surgical operations in hospitals. A large proportion, around 20%, develop persistent postoperative pain which affects their quality of life and their recovery towards a normal life.

A questionaire specifically developed using in depth interviews with patients that has undergone surgery has been developed. This questionaire will be used for longterm follow in patients undergoing thoracic surgery. 200 patients will be asked to fill in this questionaire preoperatively as well as 3 and 12 months after surgery to assess symptomburden after surgery with specific aim to study postoperative pain as well as other physical, mental and cognitive problems that may affect the patient and their daily activities, health, return to work, family life and economy.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients undergoing thoracic surgery (thoracotomy or thoracoscopy) who accept to participate in the study

Exclusion Criteria:

Study Design


Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain 3 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire Pain at 3 months after surgery as compared to prior to surgery Pain at 3 months after surgery as compared to preoperatively
Secondary Postoperative functional impairment after surgery assessed with a studyspecific questionnaire Physical, mental and cognitive problems were assessed with a studyspecific questionaire 3 months after surgery as compared to preoperatively Status at 3 months after surgery as compared to before the operation
Secondary Postoperative functional impairment 12 months after surgery assessed with a studyspecific questionnaire 12 month after surgery Physical, mental and cognitive problems 12 months after surgery Status 12 months after surgery compared to before surgery
Secondary Postoperative pain 12 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire Pain at 12 months after surgery as compared to prior to surgery Pain at 12 months after surgery as compared to preoperatively
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