Methods of Colonic Transendoscopic Enteral Tubing
- Conditions
- Colonic Transendoscopic Enteral Tubing
- Interventions
- Procedure: colonic transendoscopic enteral tubing
- Registration Number
- NCT03621033
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 207
- 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.
- Data was not recorded as required; Before and after implantation is not the same physician operation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description non-transparent cap-assisted endoscopic intubation colonic transendoscopic enteral tubing we do not use transparent cap-assisted endoscopic intubation. transparent cap-assisted endoscopic intubation colonic transendoscopic enteral tubing we use transparent cap-assisted endoscopic intubation in the second insertion.
- Primary Outcome Measures
Name Time Method The second cecal intubation time one day Record the time of colonoscopy from the anus to the ileal flap in the second insertion.
- Secondary Outcome Measures
Name Time Method 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
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.
TET success rate one day The success rate of of the TET procedure
Retention time of tube three month Retention time of colonic transendoscopic enteral tubing
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.
Trial Locations
- Locations (2)
Fmt-Dt-N-27/1350
🇨🇳Nanjing, Jiangsu, China
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China