Anorectal Diseases, Constipation, Diarrhea, Drug-Related Side Effects and Adverse Reactions, Morbid Obesity
Conditions
Keywords
GLP-1 receptor agonist, obesity, anorectal symptoms, hemorrhoids, anal fissure, constipation, semaglutide, tirzepatide, proctologic examination, bowel habits, anorectal disease, proctology
Brief summary
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.
Detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used in the treatment of obesity and type 2 diabetes mellitus. Although gastrointestinal adverse effects such as constipation, diarrhea, nausea, delayed gastric emptying, and altered bowel habits are well recognized, their potential impact on anorectal symptoms and proctologic diseases remains poorly investigated. Changes in bowel habits and stool consistency associated with GLP-1 RA therapy may contribute to the development or progression of anorectal disorders including hemorrhoidal disease, anal fissures, perianal irritation, pruritus ani, and fecal incontinence. However, prospective clinical data evaluating these associations are lacking. This prospective observational cohort study aims to evaluate the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants who are newly prescribed GLP-1 RA treatment will undergo baseline assessment before treatment initiation and follow-up evaluation at 3 months. Baseline evaluation will include demographic characteristics, comorbidities, bowel habit assessment, anorectal symptom assessment, and standardized proctologic examination including perianal inspection, digital rectal examination, and anoscopy. Follow-up evaluation at 3 months will reassess symptoms and repeat proctologic examination. The primary objective is to determine the incidence of newly developed proctologic diseases during the first 3 months after initiation of GLP-1 receptor agonist therapy. Secondary objectives include evaluating changes in anorectal symptom severity, bowel habits, progression of pre-existing anorectal disease, and the relationship between weight loss magnitude and anorectal symptoms.
Interventions
Participants 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.
Sponsors
Gazi University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Ability to attend 3-month follow-up visit
Exclusion criteria
* Inflammatory bowel disease * Perianal Crohn's disease * History of anorectal malignancy * Previous pelvic radiotherapy * Anorectal surgery within the previous 3 months * Pregnancy * Neurogenic bowel dysfunction * Inability to comply with follow-up visits * Discontinuation of GLP-1 receptor agonist therapy before follow-up assessment * Active anorectal infection or abscess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of newly developed proctologic disease | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in anorectal symptom severity | Baseline to 3 months | Comparison of anorectal symptom severity between baseline and 3-month follow-up assessment. |
| Change in bowel movement frequency | Baseline to 3 months | 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 | 3 months | 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 | 3 months | 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. |
| Change in Bristol Stool Form Scale score | Baseline to 3 months | Change in Bristol Stool Form Scale score (Bristol Stool Form Scale, range 1-7; lower scores indicate harder stools and higher scores indicate looser stools) between baseline and 3-month follow-up. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMesut Yavaş, MD, Assistant of Professor
Outcome results
None listed