NCT00596778

Brief Summary

Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

Shorter than P25 for not_applicable

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

Enrollment Period

10 months

First QC Date

January 8, 2008

Last Update Submit

January 16, 2008

Conditions

Abdominal SurgerySpirometryChest Physiotherapy

Keywords

Physical therapy specialtyPostoperative period. Abdominal surgeryAnesthesia recovery periodSpirometry

Outcome Measures

Primary Outcomes (1)

  • Effective of chest physiotherapy before and after surgery

    3 days (before surgery - second post operative)

Study Arms (1)

C, CP

OTHER

Thirty-one adults were randomly assigned to control (C) and chest physiotherapy (CP) groups. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not.

Other: chest physiotherapy

Interventions

chest physiotherapyOTHER

The protocol consisted of breathing exercises during 30 minutes and included: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion.

C, CP

Eligibility Criteria

Age21 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-operative for elective upper abdominal surgery, such as - hernia repair, gall bladder or large bowel removal, exploratory laparotomy, and submitted to general anesthesia or other interventions in abdominal cavity accomplished by conventional laparotomy

You may not qualify if:

  • Patients with indication of liver transplant or bearers of aneurysm of any arterial segment.
  • Patients submitted to video-laparoscopy surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

February 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

January 17, 2008

Record last verified: 2008-01