Postoperative Recovery After Thoracic Surgery (POLO)

Postoperative Recovery and Longterm Outcome After Thoracic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Postoperative Pain

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, S-413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Stefan Lundin, MD PhD; Phone Number: +46 708744379; Email: stefan.lundin@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planned to undergo thoracotomy or thoracoscopy at Sahgrenska University Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Thoracic surgery; Patients undergoing thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Stefan Lundin, MD PhD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: LUA-74206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No