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

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

Study Overview

• Status: Completed
• Conditions: Stent Occlusion; Long-term Oncologic Results
• Intervention / Treatment: Device: stenting

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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Laura Mora López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

: patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term outcomes	survival rates	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic leak	surgery	30 days

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Anna Pallisera-Lloveras; Xavier Serra-Aracil

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Malignant colonic obstruction; self-expandable metallic stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: TAULI-STENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There's no sharing plan because the study has finished the recruited time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No