UnknownNot Applicable

Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy

Russia56 participantsStarted 2019-11-01

Plain-language summary

Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients are 18 years old or older
✓. Stage I-IV according to TNM classification
✓. Patients with malignant colonic obstruction
✓. Overall health status according to ASA classification: I-III
✓. Overall health status according to Charlson comorbidity index ≤ 8 points
✓. Signed informed consent with agreement to attend all study visits
✓. The patient is not pregnant

Exclusion criteria

✕. Inflammatory bowel disease
✕. Acute purulent process in the abdominal cavity
✕. The patient wants to withdraw from the clinical trial
✕. Loss to follow-up

What they're measuring

Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale

Timeframe: on the 3rd day after obstruction treatment (SEMS or stoma formation)

Trial details

NCT IDNCT05643989

SponsorRussian Society of Colorectal Surgeons

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

Contact for this trial

Irina Gorovaia, MD

+79175998459 rudenko@kkmx.com

View on ClinicalTrials.gov More Neoplasms,Colorectal trials