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Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111042
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Xavier Serra-Aracil
Anna Pallisera-Lloveras
Information provided by (Responsible Party):
Laura Mora-Lopez, Corporacion Parc Tauli

Brief Summary:
Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.

Condition or disease Intervention/treatment
Stent Occlusion Long-term Oncologic Results Device: stenting

Detailed Description:
Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: stenting
    stenting procedure in patients diagnosed malignant large bowel occlusion


Primary Outcome Measures :
  1. long-term outcomes [ Time Frame: 2 years ]
    survival rates


Secondary Outcome Measures :
  1. anastomotic leak [ Time Frame: 30 days ]
    surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
: patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.
Criteria

Inclusion Criteria:

  • Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
  • Elective surgery.
  • Location in transverse, left or sigmoid colon.
  • Patients who signed the informed consent documentation and agreed to undergo the procedure.

Exclusion Criteria:

  • Benign pathology and palliative treatment.
  • Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
  • Previous chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111042


Locations
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Spain
Laura Mora López
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Xavier Serra-Aracil
Anna Pallisera-Lloveras

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Responsible Party: Laura Mora-Lopez, DR, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04111042    
Other Study ID Numbers: TAULI-STENT
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There's no sharing plan because the study has finished the recruited time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Mora-Lopez, Corporacion Parc Tauli:
Malignant colonic obstruction
self-expandable metallic stent
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases