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

Launched by RUSSIAN SOCIETY OF COLORECTAL SURGEONS · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help patients with malignant colonic obstruction, which is a blockage in the large intestine caused by cancer. The main goal is to compare the effectiveness of a self-expandable metal stent (SEMS), which is a small tube placed in the intestine to keep it open, against a diverting stoma, which is a surgical procedure that creates an opening in the abdomen for waste to leave the body. This trial aims to find out which method is better in preparing patients for surgery.

To be eligible for this study, participants must be at least 18 years old and have a diagnosed malignant colonic obstruction. They should be in relatively good health, with certain limitations on their overall health status. Patients who are pregnant, have inflammatory bowel disease, or are experiencing severe abdominal infections cannot participate. Those who join the trial will need to provide consent and attend regular study visits. This research could help improve treatment options for future patients facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients are 18 years old or older
• • 2. Stage I-IV according to TNM classification
• • 3. Patients with malignant colonic obstruction
• • 4. Overall health status according to ASA classification: I-III
• • 5. Overall health status according to Charlson comorbidity index ≤ 8 points
• • 6. Signed informed consent with agreement to attend all study visits
• • 7. The patient is not pregnant
• Exclusion Criteria:
• • 1. Inflammatory bowel disease
• • 2. Acute purulent process in the abdominal cavity
• • 3. The patient wants to withdraw from the clinical trial
• • 4. Loss to follow-up

Trial Officials