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Enteral Stents for Colonic Obstruction

NCT00591695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2018-07-26

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Colorectal Obstruction

Interventions

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

PROCEDURE

Emergency Surgery

Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy

Sponsors & Collaborators

  • European Association for Endoscopic Surgery

    lead OTHER

Principal Investigators

  • Mario Morino, Professor of Surgery · University of TORINO - European Association for Endoscopic Surgery

  • Eduardo M Targarona, Professor of Surgery · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00591695 on ClinicalTrials.gov