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

Completed

• Conditions: Long-term Oncologic Results; Stent Occlusion

• Registration Number: NCT04111042
• Lead Sponsor: Corporacion Parc Tauli

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 Timeline

• Study Start: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2019-08
• Status Verified: 2019-09
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
long-term outcomes	2 years	survival rates

Secondary Outcome Measures

Name	Time	Method
anastomotic leak	30 days	surgery

Trial Locations

Locations (1)

Laura Mora López; 🇪🇸 Sabadell, Barcelona, Spain