Postoperative Pulmonary Complications in Abdominal Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University of Udine
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
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

Contacts
Contact: Giorgio Della Rocca, Professor +39 0432 559501 giorgio.dellarocca@uniud.it

Locations
Italy
Desenzano Hospital Not yet recruiting
Desenzano del Garda, Brescia, Italy, 25015
Contact: Nicola Petrucci       ni.petrucci@tiscali.it   
Principal Investigator: Nicola Petrucci, MD         
C.E.S.A.T. S. Pietro Igneo Hospital Not yet recruiting
Fucecchio, Firenze, Italy, 50054
Contact: Emanuele Mori       emanuele.mori@gmail.com   
Principal Investigator: Emanuele Mori, MD         
San Gerardo Hospital Not yet recruiting
Monza, Monza e Brianza, Italy, 20900
Contact: Roberto Fumagalli       r.fumagalli@hsgerardo.org   
Principal Investigator: Roberto Fumagalli, MD         
Ceccarini Hospital Not yet recruiting
Riccione, Rimini, Italy, 47838
Contact: Alessandro Gatta       alessandrogatta@gmail.com   
Principal Investigator: Alessandro Gatta, MD         
Institute For Cancer Research And Treatment Not yet recruiting
Candiolo, Torino, Italy, 10060
Contact: Francesco Bona       mantis96@gmail.com   
Principal Investigator: Francesco Bona, MD         
S.Luigi Gonzaga Hospital Not yet recruiting
Orbassano, Torino, Italy, 10043
Contact: Augusto Tempia       augusto.tempia@unito.it   
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    giorgio.dellarocca@uniud.it   
Principal Investigator: Giorgio Della Rocca, MD, Professor, PI         
Orlandi Hospital Not yet recruiting
Bussolengo, Verona, Italy, 37012
Contact: Plinio Calligaro       pcalligaro@ulss22.ven.it   
Principal Investigator: Plinio Calligaro, MD         
Italian National Research Centres On Aging Not yet recruiting
Ancona, Italy
Contact: Gabriella Bettelli       g.bettelli@inrca.it   
Principal Investigator: Gabriella Bettelli, MD         
Cardinal Massaia Hospital Not yet recruiting
Asti, Italy, 14100
Contact: Agostino Roasio       aroasio@asl.at.it   
Principal Investigator: Agostino Roasio, MD         
Bari Hospital Not yet recruiting
Bari, Italy, 70131
Contact: Salvatore Grasso       sgrasso@rianima.uniba.it   
Principal Investigator: Salvatore Grasso, MD         
S.Orsola-Malpighi Hospital Not yet recruiting
Bologna, Italy, 40138
Contact: Maurizio Fusari       maurizio.fusari@fastwebnet.it   
Principal Investigator: Maurizio Fusari, MD         
Catania Hospital (Policlinico) Not yet recruiting
Catania, Italy, 95123
Contact: Antonino Gullo       a.gullo@policlinico.unict.it   
Principal Investigator: Antonino Gullo, MD         
Cannizzaro Emergency Hospital Not yet recruiting
Catania, Italy, 95126
Contact: Luigi Vicari       mednemo@gmail.com   
Principal Investigator: Luigi Vicari, MD         
S. Anna Hospital Not yet recruiting
Ferrara, Italy, 44124
Contact: Teresa Matarazzo       t.matarazzo@ospfe.it   
Principal Investigator: Teresa Matarazzo, MD         
Careggi Hospital Not yet recruiting
Firenze, Italy, 50134
Contact: Raffaele De Gaudio       rdegaudio@tin.it   
Principal Investigator: Raffaele De Gaudio, MD         
S. Maria Nuova Hospital Not yet recruiting
Firenze, Italy, 50123
Contact: Antonio Franco       antonio.franco@asf.toscana.it   
Principal Investigator: Antonio Franco, MD         
Mugello Hospital Not yet recruiting
Firenze, Italy, 50122
Contact: Vieri Parrini       vieri.parrini@asf.toscana.it   
Principal Investigator: Vieri Parrini, MD         
IRCCS San Martino Not yet recruiting
Genova, Italy, 16132
Contact: Luigi Spagnolo       luigispagnolo1@yahoo.it   
Principal Investigator: Luigi Spagnolo, MD         
Fazzi Hospital Not yet recruiting
Lecce, Italy, 73100
Contact: Luigi Fuggiano       luigifuggiano@gmail.com   
Principal Investigator: Luigi Fuggiano, MD         
Macerata Hospital Not yet recruiting
Macerata, Italy, 62100
Contact: Giuseppe Tappata       giuseppe.tappatà@sanita.marche.it   
Principal Investigator: Giuseppe Tappata, MD         
Mantova Hospital Not yet recruiting
Mantova, Italy, 46100
Contact: Vincenzo Sgarioto       vincenzo.sgarioto@aopoma.it   
Principal Investigator: Vincenzo Sgarioto, MD         
European Institute Of Oncology Not yet recruiting
Milano, Italy, 20141
Contact: Daniele Sances       daniele.sances@ieo.it   
Principal Investigator: Daniele Sances, MD         
San Paolo Hospital, University Of Milano Not yet recruiting
Milano, Italy, 20142
Contact: Concezione Tommasino       concezione.tommasino@unimi.it   
Principal Investigator: Tommasino Concezione, MD         
Niguarda Ca' Granda, Milano Not yet recruiting
Milano, Italy, 20162
Contact: Ines Arpino       inesarpino@hotmail.com   
Principal Investigator: Ines Arpino, MD         
IRCCS S. Raffaele, Milano Not yet recruiting
Milano, Italy, 20132
Contact: Elena Bignami, MD       bignami.elena@hsr.it   
Principal Investigator: Elena Bignami, MD         
Sub-Investigator: Giacomo Moniti, MD         
Federico II Hospital Not yet recruiting
Napoli, Italy, 80131
Contact: Rosalba Tufano       rtufano@unina.it   
Principal Investigator: Rosalba Tufano, MD         
Major Charity Hospital Not yet recruiting
Novara, Italy, 28100
Contact: Valeria Viarengo       valeria.viarengo@maggioreosp.novara.it   
Principal Investigator: Valeria Viarengo, MD         
IRCCS San Matteo Hospital Not yet recruiting
Pavia, Italy, 27100
Contact: Antonio Braschi       antonio.braschi@unipv.it   
Principal Investigator: Antonio Braschi, MD         
S.Maria of Mercy Hospital Not yet recruiting
Perugia, Italy, 06156
Contact: Paola Fabbricini       paola.fabbriccini@unipg.it   
Principal Investigator: Paola Fabbricini, MD         
Nuovo Santa Chiara Hospital Not yet recruiting
Pisa, Italy, 56100
Contact: Francesco Forfori       forforiden@libero.it   
Principal Investigator: Francesco Forfori, MD         
Prato Hospital Not yet recruiting
Prato, Italy, 59100
Contact: Guglielmo Consales       gconsales@gmail.com   
Principal Investigator: Guglielmo Consales, MD         
Catholic University Hospital A. Gemelli Not yet recruiting
Rome, Italy, 00168
Contact: Paolo Primieri       p.primieri@libero.it   
Principal Investigator: Paolo Primieri, MD         
Umberto I, "Sapienza", University of Rome Not yet recruiting
Rome, Italy, 00161
Contact: Franco Ruberto       rube2005@libero.it   
Principal Investigator: Franco Ruberto, MD         
Sub-Investigator: Maurizio Marandola, MD         
Sub-Investigator: Sergio Gazzanelli, MD         
Sub-Investigator: Di Marco Pierangelo, MD         
San Giovanni Battista Hospital Not yet recruiting
Torino, Italy, 10126
Contact: Elisabetta Cerutti       ecerutti@molinette.piemonte.it   
Principal Investigator: Elisabetta Cerutti, MD         
S.Maria di Ca' Foncello Not yet recruiting
Treviso, Italy, 31100
Contact: Roberto Nani       rnani@ulss.tv.it   
Principal Investigator: Roberto Nani, MD         
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 August 01, 2014