Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNicolaus Copernicus University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
participants of both sexes aged above 18 years
participants, who provided informed consent for such treatment
eligibility for Hartmann's procedure according to current medical knowledge based on evidence-based medicine.
Disqualifiers
pregnancy, breastfeeding, or intention to become pregnant during the study
contraindications to electrosurgical instruments
allergy to any of the materials used in the study
participants with advanced cancer in the metastatic stage
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic restoration of gastrointestinal continuity after Hartmann procedure
Procedure/SurgeryEndoHARP 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Endoscopic Ultrasound- Guided Hartmann Reversal ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Evaluation of efficacy based on patency of endoscopic entero-rectal anastomosis confirmed radiologically and endoscopically. Unit of Measure: the number of participants with patency of endoscopic entero-rectal anastomosis compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Time frame
12 months2
Rate of complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Evaluation of all complications in patients with endoscopic gastrointestinal anastomoses (Endo-HARP). Unit of Measure: the number of participants with complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
Time frame
12 monthsSecondary outcomes
1
Rate of early complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Evaluation of early complications within thirty days from onset of endoscopic gastrointestinal anastomoses (Endo-HARP) procedure. Unit of Measure: the number of participants with early complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
Time frame
30 days2
Rate of late complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Evaluation of late complications after thirty days from onset of endoscopic gastrointestinal anastomoses (Endo-HARP) procedure. Unit of Measure: the number of participants with late complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
Time frame
12 months3
Rate of technical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Assessment of correct conduct of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP) according to study protocol. Unit of Measure: the number of participants with technical success to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
Time frame
duration of procedure4
Rate of clinical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
Assessment of clinical results of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP). Unit of Measure: the number of participants with clinical success to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).
Time frame
12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicolaus Copernicus University
Lead sponsor
Medical University of Łódź
Collaborator
Source ClinicalTrials.gov
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