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

Stent Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111042
• Other study ID #: TAULI-STENT
• Status: Completed
• Start date: April 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2019
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 2019
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Obstruction
• Long-term Oncologic Results
• Stent Occlusion

Intervention

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

Locations

Country	Name	City	State
Spain	Laura Mora López	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Anna Pallisera-Lloveras, Xavier Serra-Aracil

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term outcomes	survival rates	2 years
Secondary	anastomotic leak	surgery	30 days