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

NCT ID: NCT04111042

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stent Occlusion Long-term Oncologic Results

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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stenting

stenting procedure in patients diagnosed malignant large bowel occlusion

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xavier Serra-Aracil

UNKNOWN

Sponsor Role collaborator

Anna Pallisera-Lloveras

UNKNOWN

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Laura Mora-Lopez

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laura Mora López

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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TAULI-STENT

Identifier Type: -

Identifier Source: org_study_id

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