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Postoperative Pulmonary Complications in Abdominal Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by University of Udine.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, University of Udine
ClinicalTrials.gov Identifier:
NCT01701908
First received: September 30, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to the population under examination and the criteria used to define pulmonary complications. There is no univocal definition of PPCs. Usually physicians associate atelectasis, respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the evaluation of risk factors has become difficult.

The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery (general surgery, gynecology, urology).

This is an observational, descriptive, prospective, multicentric study. Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge (clinical phase). Then they will be followed up until one year later.


Condition
Postoperative Pulmonary Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study

Further study details as provided by University of Udine:

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia.
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years
  • Ability to provide informed consent
  • Elective surgery
  • Laparotomic or laparoscopic major abdominal surgery
  • Major urological surgery (performed under general anesthesia)
  • Major gynecological surgery (performed under general anesthesia)

Exclusion Criteria:

  • Patients undergoing urgent or emergent surgery
  • Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery
  • Patients with chronic neuro-muscular junction disorders
  • Immunocompromised or immunodepressed patients
  • Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)
  • Patients with preoperative mechanical ventilation
  • Patients with preoperative SpO2 <90%, PaO2 <60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio <300, or PaCO2 >45 mmHg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701908

Locations
Italy
Desenzano Hospital
Desenzano del Garda, Brescia, Italy, 25015
C.E.S.A.T. S. Pietro Igneo Hospital
Fucecchio, Firenze, Italy, 50054
San Gerardo Hospital
Monza, Monza e Brianza, Italy, 20900
Ceccarini Hospital
Riccione, Rimini, Italy, 47838
Institute For Cancer Research And Treatment
Candiolo, Torino, Italy, 10060
S.Luigi Gonzaga Hospital
Orbassano, Torino, Italy, 10043
S. Valentino Hospital
Montebelluna, Treviso, Italy, 31044
Department of Anesthesia and Intensive Care Medicine of the Medical School of the University of Udine (Coordinating center)
Udine, UD, Italy, 33100
Orlandi Hospital
Bussolengo, Verona, Italy, 37012
Italian National Research Centres On Aging
Ancona, Italy
Cardinal Massaia Hospital
Asti, Italy, 14100
Bari Hospital
Bari, Italy, 70131
S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Catania Hospital (Policlinico)
Catania, Italy, 95123
Cannizzaro Emergency Hospital
Catania, Italy, 95126
S. Anna Hospital
Ferrara, Italy, 44124
Mugello Hospital
Firenze, Italy, 50122
S. Maria Nuova Hospital
Firenze, Italy, 50123
Careggi Hospital
Firenze, Italy, 50134
IRCCS San Martino
Genova, Italy, 16132
Fazzi Hospital
Lecce, Italy, 73100
Macerata Hospital
Macerata, Italy, 62100
Mantova Hospital
Mantova, Italy, 46100
IRCCS S. Raffaele, Milano
Milano, Italy, 20132
European Institute Of Oncology
Milano, Italy, 20141
San Paolo Hospital, University Of Milano
Milano, Italy, 20142
Niguarda Ca' Granda, Milano
Milano, Italy, 20162
Federico II Hospital
Napoli, Italy, 80131
Major Charity Hospital
Novara, Italy, 28100
IRCCS San Matteo Hospital
Pavia, Italy, 27100
S.Maria of Mercy Hospital
Perugia, Italy, 06156
Nuovo Santa Chiara Hospital
Pisa, Italy, 56100
Prato Hospital
Prato, Italy, 59100
Umberto I, "Sapienza", University of Rome
Rome, Italy, 00161
Catholic University Hospital A. Gemelli
Rome, Italy, 00168
San Giovanni Battista Hospital
Torino, Italy, 10126
S.Maria di Ca' Foncello
Treviso, Italy, 31100
Sponsors and Collaborators
University of Udine
Investigators
Principal Investigator: Giorgio Della Rocca, Professor University of Udine
  More Information

Publications:

Responsible Party: Giorgio Della Rocca, MD, Principal Investigator, University of Udine
ClinicalTrials.gov Identifier: NCT01701908     History of Changes
Other Study ID Numbers: PPC2012 
Study First Received: September 30, 2012
Last Updated: October 5, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Udine:
PPCs
abdominal surgery
postoperative infections
postoperative residual curarization
tracheal re-intubation
mortality
ICU stay

ClinicalTrials.gov processed this record on December 08, 2016