NCT03602664

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

June 5, 2018

Last Update Submit

August 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative functional impairment after surgery assessed with a studyspecific questionnaire

    Status at 3 months after surgery as compared to before the operation

  • Postoperative functional impairment 12 months after surgery assessed with a studyspecific questionnaire 12 month after surgery

    Status 12 months after surgery compared to before surgery

  • Postoperative pain 12 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire

    Pain at 12 months after surgery as compared to preoperatively

Study Arms (1)

Thoracic surgery

Patients undergoing thoracic surgery

Eligibility Criteria

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

Patients planned to undergo thoracotomy or thoracoscopy at Sahgrenska University Hospital

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Stefan Lundin, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Lundin, MD PhD

CONTACT

Sigrun Asgeirsdottir, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adj Professor

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 27, 2018

Study Start

June 5, 2018

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations