NCT04502420

Brief Summary

The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery. Inclusion: Patients undergoing surgery for abdominal surgery Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies. Investigation: The day before surgery and the day after surgery Primary outcome measures:

  • Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.
  • PaO2, PaCO2 and oxygen saturation (blood gas)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

July 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

July 28, 2020

Last Update Submit

January 21, 2023

Conditions

Keywords

Lung functionDiffusion capacityPostoperative complicationsAbdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Diffusion capacity for carbon monoxide (DLCO)

    Change in DLCO

    Change from baseline (the day before surgery) to postoperative day 1 or 2

Secondary Outcomes (4)

  • Vital capacity (VC)

    Change from baseline (the day before surgery) to postoperative day 1 or 2

  • Forced expiratory volume (FEV1)

    Change from baseline (the day before surgery) to postoperative day 1 or 2

  • Arterial PO2

    Change from baseline (the day before surgery) to postoperative day 1 or 2

  • Arterial PCO2

    Change from baseline (the day before surgery) to postoperative day 1 or 2

Study Arms (1)

Abdominal surgery

People who to be operated in the abdomen are investigated before and after surgery.

Diagnostic Test: Lung function before and after surgery

Interventions

A diagnostic test

Also known as: Diffusion capacity and arterial blood gas before and after surgery.
Abdominal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of 18 years old or olderundergoing abdominal surgery at department of Surgery, Urology and Gynecologi Umeå University hospital

You may qualify if:

  • Adult patients (18 years old and older) scheduled for surgery in the abdomen at department of Surgery, Urology and Gynecologi, Umeå University hospital.
  • Must be able to perform a lung function test

You may not qualify if:

  • Dementia or severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept surgery,

Umeå, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karl A Franklin, Prof

    Inst Surgical and periopertive sciences, Umeå university, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 6, 2020

Study Start

August 17, 2020

Primary Completion

October 17, 2021

Study Completion

October 17, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

We plan to share IPD if possible according to Swedish legislation

Locations