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OpenTrials
Completed

NCT Number: NCT04111042

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.

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Key information

Conditions

Stent Occlusion Long-term Oncologic Results

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laura Mora López

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stenting

Device

stenting procedure in patients diagnosed malignant large bowel occlusion

Primary outcomes

  1. long-term outcomes

    Time frame: 2 years

    survival rates

Secondary outcomes

  1. anastomotic leak

    Time frame: 30 days

    surgery

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Anna Pallisera-Lloveras
  • Xavier Serra-Aracil

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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