An interventional study of Stoma formation and Endoscopic self-expandable metal stent placement in Neoplasms,Colorectal, sponsored by Russian Society of Colorectal Surgeons. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Russian Society of Colorectal Surgeons · Not applicable, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 56 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Russian Society of Colorectal Surgeons is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Anesthesia will include only propofol injection. 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.
Procedure: Endoscopic self-expandable metal stent placement
Anesthetic care will include general endotracheal anesthesia with positioning of nasogastric tube and bladder catheterization. The diverting stoma formation will be proceed in 10 sm proximally to tumor.
Procedure: Stoma 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.
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.
Bowel preparation (absence of feaces) according to Boston Bowel Preparation Scale
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
Time frame: on the 3rd day after obstruction treatment (SEMS or stoma formation)
Intraoperative complications rate during stoma formation or stent placement
The rate of complications during the procedure
Time frame: 1 day (the day of procedure)
Early postoperative complications rate after stoma formation or stent placement
The rate of complications after the procedure
Time frame: up to 7 days after procedure
Length of hospital stay after stoma formation or stent placement
Number of days spent in hospital after procedure
Time frame: 30 days after procedure
Quality of life before and after stoma formation or stent placement
Measured by patient-reported SF-36 scale before and after procedure
Time frame: -1 day (before procedure), 3rd and 7th day after procedure
Operation time of resectional surgery
The duration of surgical procedure in minutes
Time frame: 1 day (the day of tumor resection surgery )
Stoma formation rate
The percentage of patients who had preventive or definitive stoma during resectional surgery in the SEMS group
Time frame: 1 day (the day of tumor resection surgery )
Stoma reversal rate
The rate of previously formed stoma reversal simultaneously with tumor resection
Time frame: 1 day (the day of tumor resection surgery )
Early postoperative complications rate after resectional surgery
The rate complications after tumor resection surgery
Time frame: 30 days after resectional surgery
Length of hospital stay after resectional surgery
Number of days spent in hospital after tumor resection surgery
Time frame: 30 days after resectional surgery
Intraoperative complications rate during resectional surgery
The rate of complications during tumor resection surgery
Time frame: 1 day (the day of resectional surgery)
Late complications rate during resectional surgery
The rate of complications after tumor resection surgery
Time frame: 31-90 days after tumor resection surgery
Plan to share: No
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Russian Society of Colorectal Surgeons