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Clinical Trials/NCT04111042
NCT04111042CompletedNot Applicable

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

Corporacion Parc Tauli1 site in 1 country117 target enrollmentStarted: April 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
117
Locations
1
Primary Endpoint
long-term outcomes

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

long-term outcomes

Time Frame: 2 years

survival rates

Secondary Outcomes

  • anastomotic leak(30 days)

Investigators

Sponsor
Corporacion Parc Tauli
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Mora-Lopez

DR

Corporacion Parc Tauli

Study Sites (1)

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