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
Laura Mora-Lopez
DR
Corporacion Parc Tauli
Study Sites (1)
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