Clinical Trial: Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis (Japan)

Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000053264) titled 'Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis' on Oct. 17.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Teikyo University

Condition: Condition - Hinchey Ib/II colonic diverticulitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Acute diverticulitis is the most common clinical complication of diverticular disease. The incidence rate of acute diverticulitis, such as bleeding, perforation, fistulae, obstruction or stricture, is approximately 10-25% of patients with diverticula, and 1-2% patients require hospitalization, and 0.5% patients require surgery due to abscess or peritonitis. Minimally invasive imaging-guided drainage procedure with either CT or ultrasonography (US)-guided drainage methods are commonly used for Stage 1b and Stage 2 for the patients with abscess-forming colonic diverticulitis. In this study, we conducted a single-center, prospective pilot study to investigate the efficacy and safety of endoscopic transluminal abscess drainage for colonic diverticulitis accompanied by abscesses (Hinchey stage Ib/II). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - If Hinchey Stage I or II is diagnosed by abdominal CT examination, conservative treatment such as fasting and administration of antibiotics is standard, but endoscopic examination is recommended in cases where symptoms such as abdominal pain and fever do not improve even with standard treatment. Consider mirror drainage. Although additional surgical treatment is standard, endoscopic drainage is intended for this group of cases and is performed to avoid surgical treatment. However, if the patient requests surgical treatment upon obtaining informed consent from the patient, surgical treatment shall be performed immediately without performing endoscopic drainage. When obtaining informed consent, explain that surgical treatment is the standard treatment and present the possibility of avoiding surgical treatment with endoscopic drainage, but if this is not successful, We will explain what to do in situations where you can immediately proceed to surgical treatment. If endoscopic drainage is unsuccessful, surgical treatment should be initiated immediately. On the 1st day after endoscopic drainage, physical examination, blood tests, and abdominal CT examination will be performed. If physical findings show no reduction in abdominal pain, fever does not subside, blood tests show no reduction in inflammatory findings, or abdominal CT shows findings suspicious of perforation, such as free air, surgery should be performed. Consider transitioning to clinical therapy. If inflammatory findings are reduced and fever is reduced, and no complications such as perforation are found in blood tests or abdominal CT scans, oral intake should be started. Discharge will be determined when oral intake is possible and physical findings have disappeared. In addition, before discharge, the presence or absence of an abscess cavity will be evaluated again by abdominal CT examination.

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - Endoscopic drainage is performed for patients diagnosed with Hinchey Stage I or II by abdominal CT examination and whose symptoms such as abdominal pain and fever do not improve even with conservative treatment such as fasting and administration of antibiotics. Key exclusion criteria - Under 15 years old and over 90 years old Cases with obvious poor general condition such as deterioration of vital signs Case complicated by obvious generalized peritonitis Case with bleeding tendency Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2018 Year 12 Month 10 Day Date of IRB - 2018 Year 12 Month 18 Day Anticipated trial start date - 2018 Year 12 Month 18 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059996

Disclaimer: Curated by HT Syndication.