Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms,Colorectal
- Sponsor
- Russian Society of Colorectal Surgeons
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
Surgical treatment of MCO is associated with high mortality and frequent development of postoperative complications. Stoma formation is the traditional method of urgent treatment of MCO. Currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. It results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients. Analysis of recent publications devoted to the treatment of MCO shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. Minimally invasive endoscopic procedures as a first stage of MCO treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage. Development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (SEMS) in clinical practice. This strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery. There are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
Time Frame: on the 3rd day after obstruction treatment (SEMS or stoma formation)
Evaluated via colonoscopy in colon and rectum distal to the tumour. Total score of bowel preparation measured from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. This is evaluated by the endoscopist
Secondary Outcomes
- Intraoperative complications rate during stoma formation or stent placement(1 day (the day of procedure))
- Early postoperative complications rate after stoma formation or stent placement(up to 7 days after procedure)
- Length of hospital stay after stoma formation or stent placement(30 days after procedure)
- Quality of life before and after stoma formation or stent placement(-1 day (before procedure), 3rd and 7th day after procedure)
- Operation time of resectional surgery(1 day (the day of tumor resection surgery ))
- Stoma formation rate(1 day (the day of tumor resection surgery ))
- Stoma reversal rate(1 day (the day of tumor resection surgery ))
- Early postoperative complications rate after resectional surgery(30 days after resectional surgery)
- Length of hospital stay after resectional surgery(30 days after resectional surgery)
- Intraoperative complications rate during resectional surgery(1 day (the day of resectional surgery))
- Late complications rate during resectional surgery(31-90 days after tumor resection surgery)