CClinicalTrials.gg
CompletedNCT04111042Updated Oct 1, 2019

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

An observational study in Stent Occlusion and Long-term Oncologic Results, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Corporacion Parc Tauli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
117
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stent Occlusion
  • Long-term Oncologic Results

Keywords

  • Malignant colonic obstruction
  • self-expandable metallic stent
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In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's enrollment of 117 is below the median of 152 across 68 observational studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
117 participants (actual)
Patient registry
No

Interventions

  • Devicestenting

    stenting procedure in patients diagnosed malignant large bowel occlusion

06

What researchers measure

Primary outcomes

  1. long-term outcomes

    survival rates

    Time frame: 2 years

Secondary outcomes

  1. anastomotic leak

    surgery

    Time frame: 30 days

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Study locations

1 site
  • Laura Mora López
    Sabadell, Barcelona 08208, Spain
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References and documents

Individual participant data

Plan to share: No — There's no sharing plan because the study has finished the recruited time

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04111042
Lead sponsor
Corporacion Parc Tauli
Collaborators
Xavier Serra-Aracil, Anna Pallisera-Lloveras
Responsible party
Laura Mora-Lopez (DR, Corporacion Parc Tauli) — Principal investigator
First posted
Oct 1, 2019
Start date
Apr 2016
Primary completion
Apr 2016
Completion
Aug 2019
Last update
Oct 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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