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Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
Sponsor: Nicolaus Copernicus University
Summary
The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure. The main questions it aims to answer are: * is the endoscopic restore the gastrointestinal continuity procedure effective? * is this endoscopic procedure safe?
Official title: Endoscopic Reconstruction of the Gastrointestinal Tract After Surgical Resection Procedures Within the Large Intestine (Hartmann's Procedure- Modification of the Method Facilitating the Restoration of Gastrointestinal Continuity)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-12-01
Completion Date
2026-12-31
Last Updated
2023-09-29
Healthy Volunteers
No
Interventions
Endoscopic restoration of gastrointestinal continuity after Hartmann procedure
EndoHARP is a new technique proposed to restore gastrointestinal continuity after the Hartmann's procedure. For EndoHARP, a fixed loop of the large intestine will be identified on endosonography after an echoendoscope is inserted into the rectal stump under endoscopic guidance. Then, using the set for inserting self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) with electrocautery (as in endoscopic gastroenterostomy), EUS-guided anastomosis of the rectal stump to the large intestine loop will be performed, allowing the natural passage of intestinal contents through the endoscopic anastomosis, restoring gastrointestinal continuity. The aim of leaving the self-expandable transmural endoprosthesis in the anastomosis is not only to maintain the patency of the intestinal anastomosis of at least 20 mm in diameter, but also to diminish the risk of endoscopic intestinal anastomotic leak by completely covering the prosthesis with a polymer layer.