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Sponsored by: |
European Association for Endoscopic Surgery |
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Information provided by: | European Association for Endoscopic Surgery |
ClinicalTrials.gov Identifier: | NCT00591695 |
The purpose of this study is to verify whether stent positioning for malignant obstruction of the colon and rectum followed by elective surgery allows reduction of postoperative complications and hospital stay without worsening of evolution of the neoplastic illness, compared to emergency surgery.
Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be postoperative mortality, length of hospital stay, need for analgesia.
Condition | Intervention | Phase |
---|---|---|
Malignant Colorectal Obstruction |
Procedure: Stent bridge to surgery + elective surgery Procedure: Emergency Surgery |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomised European Multicentric Study, Comparing Enteral Stent Followed by Elective Surgery Versus Emergency Surgical Treatment in Malignant Colonic Obstruction |
Estimated Enrollment: | 0 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
positioning in emergency of a prosthetic metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
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Procedure: Stent bridge to surgery + elective surgery
positioning in emergency of a metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour
|
B: Active Comparator
emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
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Procedure: Emergency Surgery
Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carmen Balagué | +34935565671 | cbalague@santpau.es |
Contact: Alberto Arezzo, MD | +393358378243 | alberto.arezzo@unito.it |
Italy | |
Department of Surgery, Minimally Invasive Surgery Center, University of Torino | Recruiting |
Torino, Italy, 10126 | |
Contact: Mario Morino, Professor of Surgery +390116335670 mario.morino@unito.it | |
Contact: Alberto Arezzo, MD +393358378243 alberto.arezzo@unito.it | |
Principal Investigator: Mario Morino, Professor of Surgery | |
Sub-Investigator: Alberto Arezzo, MD | |
Sub-Investigator: Mauro Toppino, Associate Professor | |
Sub-Investigator: Corrado Garrone, Aggregate Professor | |
Sub-Investigator: Fabrizio Rebecchi, Aggregate Professor | |
Sub-Investigator: Giuseppe Giraudo, MD | |
Sub-Investigator: Giuseppe Benedetto, MD | |
Sub-Investigator: Giuseppe Mingrone, MD | |
Sub-Investigator: Claudio Miglietta, MD | |
Sub-Investigator: Massimiliano Mistrangelo, MD | |
Sub-Investigator: Gisella Bonnet, MD | |
Sub-Investigator: Mario Caldart, MD | |
Sub-Investigator: Aldo Garbarini, MD | |
Sub-Investigator: Ugo Serenthà, MD | |
Sub-Investigator: Giancarlo Rozio, MD | |
Sub-Investigator: Marco Rossetti, MD | |
Sub-Investigator: Giorgio Olivero, Associate Professor | |
Spain | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Eduardo M Targarona, Professor of Surgery +34935565671 etargarona@santpau.es | |
Contact: Carmen Balagué, MD +34935565671 cbalague@santpau.es | |
Principal Investigator: Eduardo M Targarona, Professor of Surgery | |
Sub-Investigator: Carmen Balagué, MD | |
Sub-Investigator: Sergio Sainz, MD | |
Sub-Investigator: Ferran Caballero, MD | |
Sub-Investigator: Carmen Martinez, MD | |
Sub-Investigator: Pilar Hernandez, MD | |
Sub-Investigator: Jorgi Garriga, MD | |
Sub-Investigator: Manuel Trias, MD |
Principal Investigator: | Mario Morino, Professor of Surgery | University of TORINO - European Association for Endoscopic Surgery |
Principal Investigator: | Eduardo M Targarona, Professor of Surgery | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Responsible Party: | Università di Torino - Hospital de la Santa Creu i Sant Pau- EAES ( Prof. Mario Morino - Prof. Eduardo Targarona ) |
Study ID Numbers: | EAES-1 |
Study First Received: | December 29, 2007 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00591695 |
Health Authority: | Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Bioethics Committee; Italy: National Institute of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Malignant Colorectal Obstruction Stent Bridge to Surgery |
Emergencies |