Enteral Stents for Colonic Obstruction - Full Text View

Sponsored by:	European Association for Endoscopic Surgery
Information provided by:	European Association for Endoscopic Surgery
ClinicalTrials.gov Identifier:	NCT00591695

Purpose

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

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

Further study details as provided by European Association for Endoscopic Surgery:

Primary Outcome Measures:

incidence of postoperative complications [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

postoperative mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
success percentage of stent positioning in emergency [ Time Frame: at stent positioning ] [ Designated as safety issue: No ]
percentage of complications related to stent positioning [ Time Frame: at stent positioning ] [ Designated as safety issue: Yes ]
length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
quality of life and survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
cost differences [ Time Frame: 3 months ] [ Designated as safety issue: No ]
oncological results (local and distant recurrence rate) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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	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	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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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

malignant colonic obstruction localized between splenic flexure and 15 cm from anal margin diagnosed by CTScan.
Possibility of endoscopy and stent location during next 24 h after diagnostic.
Clinical occlusion to gas and faeces.
Informed consent obtained from the patient or from a relative in case of inability.

Exclusion Criteria:

Bowel perforation diagnosed by clinical exploration and complementary studies.
Associated pathologies contraindicating general anaesthesia and/or haemodynamic instability.
Impossibility to gain a valid informed consent or refusal from the patient.
Patients with multiple liver metastases diagnosed by CTScan at the moment of diagnostic and not considered operable with curative intention following the standards of every center.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591695

Contacts

Contact: Carmen Balagué	+34935565671	cbalague@santpau.es
Contact: Alberto Arezzo, MD	+393358378243	alberto.arezzo@unito.it

Locations

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

Sponsors and Collaborators

European Association for Endoscopic Surgery

Investigators

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

More Information

Additional Information:

website for recruitment of patients and information of study This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by European Association for Endoscopic Surgery:

Malignant Colorectal Obstruction
Stent Bridge to Surgery

Study placed in the following topic categories:

Emergencies

ClinicalTrials.gov processed this record on February 12, 2009