Trials
Search / Trial NCT05643989

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

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

Trial Information

Current as of January 21, 2025

Unknown status

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

Petr Tsarkov, Prof

Principal Investigator

Russian Society of Colorectal Surgeons

About Russian Society Of Colorectal Surgeons

The Russian Society of Colorectal Surgeons is a leading professional organization dedicated to advancing the field of colorectal surgery through research, education, and clinical excellence. Committed to improving patient outcomes, the Society fosters collaboration among healthcare professionals, promotes innovative surgical techniques, and supports the development of clinical trials that address critical challenges in colorectal health. By leveraging its expertise and network, the Society aims to enhance the quality of care for patients with colorectal conditions, driving forward the standards of practice within the surgical community in Russia and beyond.

Locations

Moscow, , Russian Federation

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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