Colonic Transendoscopic Enteral Tubing
Conditions
Keywords
transendoscopic enteral tubing, Microbiota Transplantation, transparent cap-assisted colonoscopy
Brief summary
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
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.
Interventions
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.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The second cecal intubation time | one day | Record the time of colonoscopy from the anus to the ileal flap in the second insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TET success rate | one day | The success rate of of the TET procedure |
| Maximum insertion pain score | one day | 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. |
| Adverse events rate | All patients were followed up from date of intubation to one mouth after discharge | Procedure-related and tube-related adverse events after procedure |
| Tubing time | one day | The tubing time is from advancement of the TET tube through the channel to the end of the tubing. |
| Titanium clip fixation time | one day | Record the time required for fixing a titanium clip. |
| Retention time of tube | three month | Retention time of colonic transendoscopic enteral tubing |
Countries
China
Contacts
Primary ContactFaming Zhang, MD; PhD
Outcome results
None listed