Small Bowel Disease Clinical Trial
Official title:
Small Bowel Evaluation Using Novel Motorized Spiral Enteroscopy - Prospective Non-controlled Clinical Study From a Single Tertiary Care Centre.
Small bowel evaluation using Novel Motorized Spiral Enteroscopy - Prospective non-controlled clinical study from a single tertiary care centre. Data regarding the safety and efficacy of Novel Motorized Spiral Enteroscopy in the evaluation of the small bowel, most of them are retrospective. This study is being planned to collect the data prospectively for all the patients undergoing this procedure at our center including the follow up at 1 month for any adverse events.This will enlighten us in understanding the role of Novel Motorized Spiral in the evaluation of the small bowel Enteroscopy in the small bowel evaluation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 16, 2022 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with small bowel disease with an indication for Motorized spiral enteroscopy and age more than 10 years 2. Overt or obscure Gastrointestinal bleeding 3. Iron deficiency anaemia 4. Chronic diarrhoea 5. Abdominal pain for evaluation with suspected small bowel involvement. 6. IBD requiring small bowel evaluation 7. Polyposis syndrome requiring small bowel evaluation 8. Small bowel subacute obstruction 9. Refractory celiac disease Exclusion Criteria: 1. Weight less than 30 kg 2. Large gastric or oesophageal varices 3. Any medical contraindication to standard enteroscopy 4. Any prior history of gastric , small bowel , large bowel surgery 5. Acute obstruction of small bowel 6. Suspected GI perforation 7. Any contraindication for general anaesthesia 8. Lack of informed consent. |
Country | Name | City | State |
---|---|---|---|
India | Aniruddha Pratap Singh | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Beyna T, Arvanitakis M, Schneider M, Gerges C, Böing D, Devière J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24. — View Citation
Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Devière J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 N — View Citation
Ramchandani M, Rughwani H, Inavolu P, Singh AP, Tevethia HV, Jagtap N, Sekaran A, Kanakagiri H, Darishetty S, Reddy DN. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world exp — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total enteroscopy rate with motorized spiral enteroscopy both via antegrade and the retrograde route. | Rate of examining the total small bowel evaluation using novel motorized spiral enteroscopy | 2 days | |
Secondary | Technical success of antegrade and the retrograde approach | Passage of the scope at least till the duodenojejunal flexure | 2 days | |
Secondary | Total procedural time | Total procedural time beginning from the ligament of trietz to the maximal depth of the insertion via antegrade route and passage of the scope from the ileocecal valve to the maximal depth of the insertion via the retrograde route | 2 days | |
Secondary | Depth of the maximal insertion | Maximal depth of the insertion beyond the ligament of Trietz via the antegrade route and beyond the Ileocecal valve via the retrograde route. | 2 days | |
Secondary | Diagnostic yield | Diagnostic yield, defined as the percentage of procedures with a definitive endoscopic diagnosis (either confirmed a diagnosis from previous imaging or new diagnosis at the anatomic location identified in previous imaging studies). | 2 days | |
Secondary | Therapeutic yield | Therapeutic yield, defined as the percentage of any therapeutic procedures done excluding biopsy and hemoclip application to mark the maximal depth of insertion. | 2 days | |
Secondary | Adverse events | Any adverse events including minor or major which may require surgical intervention or ICU admission | 30 days |
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