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CompletedNCT07437716

Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years

Impact Of Laparoscopic Sleeve Gastrectomy On Obesity-Related Comorbidities In Patients Over 65 Years: A Prospective Comparative Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Kafrelsheikh University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

This study compares laparoscopic sleeve gastrectomy (a type of weight-loss surgery) with non-surgical care in adults aged 65 or older who have severe obesity and related health problems like type 2 diabetes, high blood pressure, knee joint issues from osteoarthritis, or sleep apnea. Over 12 months, 60 patients chose either surgery or diet counseling with medications for their conditions (30 in each group). The main goals are to measure improvements in these health issues, weight loss, and safety. Why This Study Matters Severe obesity in older adults raises risks for serious health conditions that diet and medications often fail to fix long-term. Surgery like sleeve gastrectomy removes part of the stomach to limit food intake and improve hormones that control hunger and blood sugar, but its benefits need direct proof against usual care in seniors. What Happens in the Study Patients picked their treatment: surgery group got the procedure plus routine care; non-surgery group got nutrition advice and standard drugs. Doctors tracked weight, blood tests, blood pressure, sleep studies, knee X-rays, drug needs, and side effects at 1, 3, 6, and 12 months.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic Sleeve Gastrectomy (LSG)Laparoscopic sleeve gastrectomy performed under general anesthesia using 5 trocars (baseball diamond technique), liver retraction (Nathanson), Ligasure dissection of greater curvature/short gastrics, 34-French bougie calibration along lesser curvature, sequential linear stapling (60-mm, 4-5 firings) from 4-6 cm proximal to pylorus to angle of His, staple line reinforcement optional, resected stomach removed via port, methylene blue leak test, and routine VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days + sequential compression devices).
BEHAVIORALStructured Dietary CounselingStructured dietary counseling providing a 500-800 kcal daily deficit, delivered by certified nutritionists, combined with guideline-directed pharmacotherapy for weight-related comorbidities (type 2 diabetes, hypertension, osteoarthritis, obstructive sleep apnea) in specialized clinics. No anti-obesity pharmacotherapy (e.g., GLP-1 receptor agonists) due to high cost and lack of insurance coverage, per patient preference

Timeline

Start date
2023-01-01
Primary completion
2025-03-01
Completion
2025-09-01
First posted
2026-02-27
Last updated
2026-02-27

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07437716. Inclusion in this directory is not an endorsement.