Methods of Colonic Transendoscopic Enteral Tubing

Study Overview
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Brief Summary
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Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.

Detailed Description
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Our previous article has reported the method of colon TET. However, the investigators found that it was difficult to find the cavity because of the concentration of intestinal folds caused by the tube pulling after insertion of TET. It is well known that transparent cap-assisted colonoscopy is easier to flatten the semilunar folds and improve mucosal exposure. Here the investigators test the hypothesis that using transparent cap-assisted colonoscopy significantly decreases the second cecal intubation time which not only improve work efficiency, but also saves patients' anesthesia time and cost. Thus, the investigators design a prospective multicenter, randomized controlled trial. The aim of this study was to evaluate the methodology, efficiency, feasibility and safety of using transparent cap-assisted endoscopy for colon TET implantation.

Official Title
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Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial

Conditions
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Colonic Transendoscopic Enteral Tubing

Intervention / Treatment
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* Procedure: colonic transendoscopic enteral tubing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diseases requiring total colonic administration and fecal microbiota transplantation. Patients and healthy Volunteers with the need to sample in deep colon . Age > 7 years. Must be able to Colonic Transendoscopic Enteral Tubing and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation. Exclusion Criteria: Data was not recorded as required; Before and after implantation is not the same physician operation.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: non-transparent cap-assisted endoscopic intubation<br>we do not use transparent cap-assisted endoscopic intubation. | Procedure: colonic transendoscopic enteral tubing<br>* The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.<br>|
| Other: transparent cap-assisted endoscopic intubation<br>we use transparent cap-assisted endoscopic intubation in the second insertion. | Procedure: colonic transendoscopic enteral tubing<br>* The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The second cecal intubation time | Record the time of colonoscopy from the anus to the ileal flap in the second insertion. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events rate | Procedure-related and tube-related adverse events after procedure | All patients were followed up from date of intubation to one mouth after discharge | 
| TET success rate | The success rate of of the TET procedure | one day | 
| Maximum insertion pain score | Using numerical rating scale to evaluate maximum insertion pain score in non anesthesia. The digital grading method uses 0-10 to represent different levels of pain, with 0 as painless and 10 as severe. The classification standard of pain degree is: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain. | one day | 
| Retention time of tube | Retention time of colonic transendoscopic enteral tubing | three month | 
| Tubing time | The tubing time is from advancement of the TET tube through the channel to the end of the tubing. | one day | 
| Titanium clip fixation time | Record the time required for fixing a titanium clip. | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transendoscopic enteral tubing, Microbiota Transplantation, transparent cap-assisted colonoscopy