Neoplasms,Colorectal
Conditions
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.
Interventions
PROCEDUREStoma formation
Trocar placement: the optical trocar (10 mm) will be inserted just near umbilicus . An abdominal revision is performed to determine the location of the tumor. Colon in 10 sm proximally to tumor is prepared for the discharge stoma formation. In the corresponding location on the anterior abdominal wall is formed incision of skin and subcutaneous tissue to the aponeurosis, the cut length is 2.5 sm. After that, aponeurosis crucial incision is performed. The previously prepared colon is brought out to the anterior abdominal wall with the help of a grasper. Discharge stoma is attached to a holding device; colon is fixed by the interrupted sutures (Polysorb 3-0). In the operating room, the stoma is opened, the intestinal patency is checked in both directions, and hemostasis is revealed. With the help of optics, the presence of intestinal tension is checked; if necessary, the colon is additionally mobilized.
PROCEDUREEndoscopic self-expandable metal stent placement
The colonoscope is passed to the distal edge of the tumor and a biopsy of the tumor is performed (if the tumor has not previously been verified). Through the tumor stenosis radioscopically guided metal conductor with atraumatic distal end installs in the proximal colon. A covered or partially covered metal self- expanding stent is placed in the area of tumor stenosis by the conductor, symmetrically in relation to the area of tumor stenosis. Radioscopically and endoscopically guided disclosure of a SEMS is performed immediately after which there is an abundant discharge of gases and intestinal contents. Upon completion of the procedure, the patient is transferred to the patient's room. The next day, a control X-ray of the abdomen is taken.
Sponsors
Russian Society of Colorectal Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative complications rate after stoma formation or stent placement | up to 7 days after procedure | The rate of complications after the procedure |
| Length of hospital stay after stoma formation or stent placement | 30 days after procedure | Number of days spent in hospital after procedure |
| Quality of life before and after stoma formation or stent placement | -1 day (before procedure), 3rd and 7th day after procedure | Measured by patient-reported SF-36 scale before and after procedure |
| Operation time of resectional surgery | 1 day (the day of tumor resection surgery ) | The duration of surgical procedure in minutes |
| Stoma formation rate | 1 day (the day of tumor resection surgery ) | The percentage of patients who had preventive or definitive stoma during resectional surgery in the SEMS group |
| Intraoperative complications rate during stoma formation or stent placement | 1 day (the day of procedure) | The rate of complications during the procedure |
| Early postoperative complications rate after resectional surgery | 30 days after resectional surgery | The rate complications after tumor resection surgery |
| Length of hospital stay after resectional surgery | 30 days after resectional surgery | Number of days spent in hospital after tumor resection surgery |
| Intraoperative complications rate during resectional surgery | 1 day (the day of resectional surgery) | The rate of complications during tumor resection surgery |
| Late complications rate during resectional surgery | 31-90 days after tumor resection surgery | The rate of complications after tumor resection surgery |
| Stoma reversal rate | 1 day (the day of tumor resection surgery ) | The rate of previously formed stoma reversal simultaneously with tumor resection |
Countries
Russia
Contacts
Primary ContactIrina Gorovaia, MD
Backup ContactInna Tulina, MD
Outcome results
None listed