Postoperative Pulmonary Complications in Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701908
Recruitment Status : Unknown
Verified October 2012 by Giorgio Della Rocca, University of Udine.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2012
Last Update Posted : October 8, 2012
Information provided by (Responsible Party):
Giorgio Della Rocca, University of Udine

Brief Summary:

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 or disease
Postoperative Pulmonary Complications

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study
Study Start Date : January 2013
Estimated Primary Completion Date : December 2013

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701908

Contact: Giorgio Della Rocca, Professor +39 0432 559501

Desenzano Hospital Not yet recruiting
Desenzano del Garda, Brescia, Italy, 25015
Contact: Nicola Petrucci   
Principal Investigator: Nicola Petrucci, MD         
C.E.S.A.T. S. Pietro Igneo Hospital Not yet recruiting
Fucecchio, Firenze, Italy, 50054
Contact: Emanuele Mori   
Principal Investigator: Emanuele Mori, MD         
San Gerardo Hospital Not yet recruiting
Monza, Monza e Brianza, Italy, 20900
Contact: Roberto Fumagalli   
Principal Investigator: Roberto Fumagalli, MD         
Ceccarini Hospital Not yet recruiting
Riccione, Rimini, Italy, 47838
Contact: Alessandro Gatta   
Principal Investigator: Alessandro Gatta, MD         
Institute For Cancer Research And Treatment Not yet recruiting
Candiolo, Torino, Italy, 10060
Contact: Francesco Bona   
Principal Investigator: Francesco Bona, MD         
S.Luigi Gonzaga Hospital Not yet recruiting
Orbassano, Torino, Italy, 10043
Contact: Augusto Tempia   
Principal Investigator: Augusto Tempia, MD         
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) Not yet recruiting
Udine, UD, Italy, 33100
Contact: Giorgio Della Rocca, Professor    +39 0432 559501   
Principal Investigator: Giorgio Della Rocca, MD, Professor, PI         
Orlandi Hospital Not yet recruiting
Bussolengo, Verona, Italy, 37012
Contact: Plinio Calligaro   
Principal Investigator: Plinio Calligaro, MD         
Italian National Research Centres On Aging Not yet recruiting
Ancona, Italy
Contact: Gabriella Bettelli   
Principal Investigator: Gabriella Bettelli, MD         
Cardinal Massaia Hospital Not yet recruiting
Asti, Italy, 14100
Contact: Agostino Roasio   
Principal Investigator: Agostino Roasio, MD         
Bari Hospital Not yet recruiting
Bari, Italy, 70131
Contact: Salvatore Grasso   
Principal Investigator: Salvatore Grasso, MD         
S.Orsola-Malpighi Hospital Not yet recruiting
Bologna, Italy, 40138
Contact: Maurizio Fusari   
Principal Investigator: Maurizio Fusari, MD         
Catania Hospital (Policlinico) Not yet recruiting
Catania, Italy, 95123
Contact: Antonino Gullo   
Principal Investigator: Antonino Gullo, MD         
Cannizzaro Emergency Hospital Not yet recruiting
Catania, Italy, 95126
Contact: Luigi Vicari   
Principal Investigator: Luigi Vicari, MD         
S. Anna Hospital Not yet recruiting
Ferrara, Italy, 44124
Contact: Teresa Matarazzo   
Principal Investigator: Teresa Matarazzo, MD         
Mugello Hospital Not yet recruiting
Firenze, Italy, 50122
Contact: Vieri Parrini   
Principal Investigator: Vieri Parrini, MD         
S. Maria Nuova Hospital Not yet recruiting
Firenze, Italy, 50123
Contact: Antonio Franco   
Principal Investigator: Antonio Franco, MD         
Careggi Hospital Not yet recruiting
Firenze, Italy, 50134
Contact: Raffaele De Gaudio   
Principal Investigator: Raffaele De Gaudio, MD         
IRCCS San Martino Not yet recruiting
Genova, Italy, 16132
Contact: Luigi Spagnolo   
Principal Investigator: Luigi Spagnolo, MD         
Fazzi Hospital Not yet recruiting
Lecce, Italy, 73100
Contact: Luigi Fuggiano   
Principal Investigator: Luigi Fuggiano, MD         
Macerata Hospital Not yet recruiting
Macerata, Italy, 62100
Contact: Giuseppe Tappata       giuseppe.tappatà   
Principal Investigator: Giuseppe Tappata, MD         
Mantova Hospital Not yet recruiting
Mantova, Italy, 46100
Contact: Vincenzo Sgarioto   
Principal Investigator: Vincenzo Sgarioto, MD         
IRCCS S. Raffaele, Milano Not yet recruiting
Milano, Italy, 20132
Contact: Elena Bignami, MD   
Principal Investigator: Elena Bignami, MD         
Sub-Investigator: Giacomo Moniti, MD         
European Institute Of Oncology Not yet recruiting
Milano, Italy, 20141
Contact: Daniele Sances   
Principal Investigator: Daniele Sances, MD         
San Paolo Hospital, University Of Milano Not yet recruiting
Milano, Italy, 20142
Contact: Concezione Tommasino   
Principal Investigator: Tommasino Concezione, MD         
Niguarda Ca' Granda, Milano Not yet recruiting
Milano, Italy, 20162
Contact: Ines Arpino   
Principal Investigator: Ines Arpino, MD         
Federico II Hospital Not yet recruiting
Napoli, Italy, 80131
Contact: Rosalba Tufano   
Principal Investigator: Rosalba Tufano, MD         
Major Charity Hospital Not yet recruiting
Novara, Italy, 28100
Contact: Valeria Viarengo   
Principal Investigator: Valeria Viarengo, MD         
IRCCS San Matteo Hospital Not yet recruiting
Pavia, Italy, 27100
Contact: Antonio Braschi   
Principal Investigator: Antonio Braschi, MD         
S.Maria of Mercy Hospital Not yet recruiting
Perugia, Italy, 06156
Contact: Paola Fabbricini   
Principal Investigator: Paola Fabbricini, MD         
Nuovo Santa Chiara Hospital Not yet recruiting
Pisa, Italy, 56100
Contact: Francesco Forfori   
Principal Investigator: Francesco Forfori, MD         
Prato Hospital Not yet recruiting
Prato, Italy, 59100
Contact: Guglielmo Consales   
Principal Investigator: Guglielmo Consales, MD         
Umberto I, "Sapienza", University of Rome Not yet recruiting
Rome, Italy, 00161
Contact: Franco Ruberto   
Principal Investigator: Franco Ruberto, MD         
Sub-Investigator: Maurizio Marandola, MD         
Sub-Investigator: Sergio Gazzanelli, MD         
Sub-Investigator: Di Marco Pierangelo, MD         
Catholic University Hospital A. Gemelli Not yet recruiting
Rome, Italy, 00168
Contact: Paolo Primieri   
Principal Investigator: Paolo Primieri, MD         
San Giovanni Battista Hospital Not yet recruiting
Torino, Italy, 10126
Contact: Elisabetta Cerutti   
Principal Investigator: Elisabetta Cerutti, MD         
S.Maria di Ca' Foncello Not yet recruiting
Treviso, Italy, 31100
Contact: Roberto Nani   
Principal Investigator: Roberto Nani, MD         
Sponsors and Collaborators
University of Udine
Principal Investigator: Giorgio Della Rocca, Professor University of Udine


Responsible Party: Giorgio Della Rocca, MD, Principal Investigator, University of Udine Identifier: NCT01701908     History of Changes
Other Study ID Numbers: PPC2012
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Giorgio Della Rocca, University of Udine:
abdominal surgery
postoperative infections
postoperative residual curarization
tracheal re-intubation
ICU stay