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

NCT04111042 | Completed

• 1 other identifier: TAULI-STENT
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stent Occlusion; Long-term Oncologic Results

Keywords

Malignant colonic obstruction; self-expandable metallic stent

Outcome Measures

Primary Outcomes (1)

• long-term outcomes

  survival rates

  2 years

Secondary Outcomes (1)

• anastomotic leak

  30 days

Interventions

stenting DEVICE

stenting procedure in patients diagnosed malignant large bowel occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Benign pathology and palliative treatment.
• Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
• Previous chemotherapy.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Xavier Serra-Aracil: collaborator
• Anna Pallisera-Lloveras: collaborator

Study Sites (1)

Laura Mora López

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 1, 2019
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)