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NCT04411186

A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function

Completed NA Results posted Last updated 5 July 2024
What this trial tests

NA trial testing Standard Enhanced Recovery After Surgery (ERAS) Protocol in Colorectal Surgery in 100 participants. Completed in 21 September 2021.

Timeline
22 March 2021
Primary endpoint
21 September 2021
21 September 2021

Quick facts

Lead sponsorMedical University of South Carolina
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment100
Start date22 March 2021
Primary completion21 September 2021
Estimated completion21 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Colorectal Surgery or Hepatobiliary Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inspiratory Capacity Primary · 2 hours

The primary outcome of interest is the inspiratory capacity obtained in the PACU via the incentive spirometer.

Preoperative incentive spirometry (average)
GroupValue95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol2,043.3± 628.4
ERAS and 5 Lung Protective Interventions2,012.2± 895.2
Postoperative incentive spirometry 30 min (average)
GroupValue95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol1,195.2± 715.0
ERAS and 5 Lung Protective Interventions1,233.3± 894.1
Postoperative incentive spirometry 1 h (average)
GroupValue95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol1,313.9± 618.1
ERAS and 5 Lung Protective Interventions1,387.3± 975.3
Postoperative incentive spirometry 2 h (average)
GroupValue95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol1,376.3± 651.2
ERAS and 5 Lung Protective Interventions1,454.8± 906.4
Postoperative incentive spirometry total (average)
GroupValue95% CI
Standard Enhanced Recovery After Surgery (ERAS) Protocol1,253.5± 593.7
ERAS and 5 Lung Protective Interventions1,390.4± 964.9

Sponsor's own description

The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Colorectal Surgery

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04411186.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing