Methods of Colonic Transendoscopic Enteral Tubing

Nanjing Medical University

Status: Unknown

Conditions: Colonic Transendoscopic Enteral Tubing

Treatments: Procedure: colonic transendoscopic enteral tubing

Study type: Interventional

Funder types: Other

Identifiers

NCT03621033

TET-CN-170803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

non-transparent cap-assisted endoscopic intubation

Other group

Description:

we do not use transparent cap-assisted endoscopic intubation.

Treatment:

Procedure: colonic transendoscopic enteral tubing

transparent cap-assisted endoscopic intubation

Other group

Description:

we use transparent cap-assisted endoscopic intubation in the second insertion.

Treatment:

Procedure: colonic transendoscopic enteral tubing