Postoperative Pulmonary Complications in Abdominal Surgery
This study is not yet open for participant recruitment.
Verified October 2012 by University of Udine
Sponsor:
University of Udine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 21, 2013