Clinical trial NCT03621033: Methods of Colonic Transendoscopic Enteral Tubing
Official title: Methods of Colonic Transendoscopic Enteral Tubing: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Transendoscopic Enteral Tubing
Keywords: transendoscopic enteral tubing
Microbiota Transplantation
transparent cap-assisted colonoscopy
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 207
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The second cecal intubation time
timeFrame: one day
Secondary outcomes:
measure: Adverse events rate
timeFrame: All patients were followed up from date of intubation to one mouth after discharge
measure: TET success rate
timeFrame: one day
measure: Maximum insertion pain score
timeFrame: one day
measure: Retention time of tube
timeFrame: three month
measure: Tubing time
timeFrame: one day
measure: Titanium clip fixation time
timeFrame: one day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Fmt-Dt-N-27/1350
state: Jiangsu
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Faming Zhang, MD; PhD
role: STUDY_CHAIR
References:
citation: Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
citation: Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.