Clinical trial NCT05643989: Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy
Official title: Randomized Non-inferiority Single-center Prospective Trial of Malignant Colonic Obstruction Therapy With Self-expandable Metal Stent (SEMS) Endoscopic Placement or Stoma Formation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms,Colorectal
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
timeFrame: on the 3rd day after obstruction treatment (SEMS or stoma formation)
Secondary outcomes:
measure: Intraoperative complications rate during stoma formation or stent placement
timeFrame: 1 day (the day of procedure)
measure: Early postoperative complications rate after stoma formation or stent placement
timeFrame: up to 7 days after procedure
measure: Length of hospital stay after stoma formation or stent placement
timeFrame: 30 days after procedure
measure: Quality of life before and after stoma formation or stent placement
timeFrame: -1 day (before procedure), 3rd and 7th day after procedure
measure: Operation time of resectional surgery
timeFrame: 1 day (the day of tumor resection surgery )
measure: Stoma formation rate
timeFrame: 1 day (the day of tumor resection surgery )
measure: Stoma reversal rate
timeFrame: 1 day (the day of tumor resection surgery )
measure: Early postoperative complications rate after resectional surgery
timeFrame: 30 days after resectional surgery
measure: Length of hospital stay after resectional surgery
timeFrame: 30 days after resectional surgery
measure: Intraoperative complications rate during resectional surgery
timeFrame: 1 day (the day of resectional surgery)
measure: Late complications rate during resectional surgery
timeFrame: 31-90 days after tumor resection surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of colorectal and minimally invasive surgery University Hospital n2, Clinical Center Sechenov First Moscow State Medical University
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Prof
role: PRINCIPAL_INVESTIGATOR
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