Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
Not applicable · Testing Endoscopic restoration of gastrointestinal continuity after Hartmann procedure · Sites not listed yet · Nicolaus Copernicus University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Endoscopic restoration of gastrointestinal continuity after Hartmann procedure (a procedure) as a possible treatment. Condition(s) listed: Colorectal Neoplasms, Diverticular Diseases and Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2023-12-01 (planned).
- Main results expected around 2024-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP) (12 months)
In the researchers’ words
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?
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Colorectal Neoplasms; Diverticular Diseases; Inflammatory Bowel Diseases |
| Lead sponsor | Nicolaus Copernicus University |
| Collaborators | Medical University of Łódź |
| Enrollment | 100 (estimated) |
| Start date | 2023-12-01 |
| Primary completion (est.) | 2024-12-31 |
| First posted | 2023-09-29 |
| Last updated | 2023-09-29 |
| 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) |
| ClinicalTrials.gov ID | NCT06061432 |
Interventions
- Endoscopic restoration of gastrointestinal continuity after Hartmann procedure (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)…
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * participants ineligible for restoration of gastrointestinal continuity * participants ineligible for surgery * participants ineligible for general anesthesia
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.