Postoperative PainPOLONCT03602664
Postoperative Recovery After Thoracic Surgery
An observational study of Postoperative Pain and Postoperative Complications, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Postoperative Complications
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 5 Jun 2018to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients planned to undergo thoracotomy or thoracoscopy at Sahgrenska University Hospital
Who may be able to join
- Patients undergoing thoracic surgery (thoracotomy or thoracoscopy) who accept to participate in the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, S-413 45
Stefan Lundin, MD PhD, +46 708744379, stefan.lundin@gu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Postoperative Complications
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery | Patients undergoing thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pain at 3 months after surgery as compared to preoperatively
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Pain at 12 months after surgery as compared to preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start5 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Lundin, Sahlgrenska University Hospital
- Investigators
- Stefan Lundin, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602664
- Sponsor's protocol ID
- LUA-74206
- Acronym
- POLO
- Status last verified
- Aug 2018
- First submitted
- 5 Jun 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery and Longterm Outcome After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03602664
- Acronym / sponsor ID
- POLO / LUA-74206
- Conditions
- Postoperative Pain, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery | – | –Patients undergoing thoracic surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned to undergo thoracotomy or thoracoscopy at Sahgrenska University Hospital
Key inclusion criteria (1 listed)
- Patients undergoing thoracic surgery (thoracotomy or thoracoscopy) who accept to participate in the study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pain 3 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire
Time frame: Pain at 3 months after surgery as compared to preoperatively
Pain at 3 months after surgery as compared to prior to surgery
3 secondary outcomes
Postoperative functional impairment after surgery assessed with a studyspecific questionnaire
Time frame: 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
Time frame: Status 12 months after surgery compared to before surgery
Postoperative pain 12 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire
Time frame: Pain at 12 months after surgery as compared to preoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Lundin, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postoperative Complications, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Lundin, MD PhD (+46 31 3428112, stefan.lundin@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain 3 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire (time frame: Pain at 3 months after surgery as compared to preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.