About this trial
Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Morbid obesity (BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities)
Newly prescribed GLP-1 receptor agonist therapy
Ability and willingness to provide written informed consent
Disqualifiers
Inflammatory bowel disease
Perianal Crohn's disease
History of anorectal malignancy
Previous pelvic radiotherapy
Trial population
Morbidly obese adult patients who are newly prescribed GLP-1 receptor agonist therapy in routine clinical practice and are referred for participation in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
GLP-1 receptor agonist therapy
DrugParticipants will receive GLP-1 receptor agonist treatment as part of routine clinical care. The study does not assign treatment but prospectively evaluates proctologic outcomes following treatment initiation.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of newly developed proctologic disease
Patients developing newly diagnosed anorectal pathology after initiation of GLP-1 receptor agonist therapy, including hemorrhoidal disease, anal fissure, pruritus ani, perianal irritation, or other proctologic conditions identified during follow-up examination.
Secondary outcomes
Change in anorectal symptom severity
Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment.
Change in bowel movement frequency
Change in the number of bowel movements per week between baseline and 3-month follow-up after initiation of GLP-1 receptor agonist therapy.
Number of participants with worsening of pre-existing anorectal disease
Number of participants demonstrating worsening of previously diagnosed anorectal disease based on changes in symptoms and findings on proctologic examination, including perianal inspection, digital rectal examination, and anoscopy.
Correlation between percent body weight loss and anorectal symptom score
Correlation between percentage body weight loss and change in anorectal symptom score from baseline to 3-month follow-up after initiation of GLP-1 receptor agonist therapy.
Sponsors and contacts
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