Colonic diverticular fecalith impaction
Conditions
Interventions
Experimental group:Endoscopic submucosal injection-assisted fecalith removal
Control group:Endoscopic fecalith removal using foreign body forceps
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–80 years, with no restriction on sex; 2.Colonic diverticula confirmed by abdominal computed tomography (CT) and/or colonoscopy, with definite fecalith impaction within a target diverticulum requiring endoscopic removal or local intervention; 3.A clearly identifiable target diverticulum whose morphology and location are considered suitable for endoscopic fecalith removal or other local endoscopic treatment following comprehensive assessment by an endoscopist; 4.Voluntary participation in the study, willingness and ability to complete the treatment, follow-up examinations, and scheduled follow-up, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Severe dysfunction of major organs or systems, including the heart, lungs, liver, kidneys, or nervous system, resulting in an inability to tolerate bowel preparation, anesthesia or sedation, colonoscopy, or endoscopic fecalith removal despite comprehensive clinical assessment, or an unacceptably high procedural risk; 2.Uncorrected coagulation disorders, active bleeding disorders, or current use of anticoagulant or antiplatelet agents that cannot be appropriately adjusted or discontinued during the periprocedural period; 3.Contraindications to colonoscopy or endoscopic treatment, including colorectal stenosis or obstruction, toxic megacolon, suspected or confirmed gastrointestinal perforation, diffuse peritonitis, or uncontrolled severe infection; 4.Acute severe diverticulitis, intra-abdominal abscess, marked signs of peritoneal irritation, suspected or confirmed colorectal malignancy, active severe inflammatory bowel disease, or other conditions requiring priority treatment that preclude immediate endoscopic fecalith removal; 5.Pregnant or breastfeeding women, or participation within the previous 3 months in another clinical trial that may affect the safety or efficacy assessments of the present study; 6.Poor adherence or inability to complete the treatment, follow-up examinations, or scheduled follow-up, or any other condition considered by the investigator to render the participant unsuitable for enrollment based on participant safety, treatment feasibility, or the reliability of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall fecalith removal success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single-attempt fecalith removal success rate;Complete fecalith removal success rate;Volume of submucosal injection;Incidence of adverse events;Duration of endoscopic fecalith removal; | — |
Countries
China
Contacts
Public ContactChaoqiang Fan
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed