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

February 24, 2026 updated by: Reda F. Ali, Kafrelsheikh University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafr ash Shaykh, Egypt
        • Kafrelsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥65 years
  • Body Mass Index (BMI) ≥40 kg/m²
  • Presence of at least one weight-related comorbidity: type 2 diabetes mellitus (T2D), hypertension (HTN), obstructive sleep apnea (OSA), or osteoarthritis (OA)
  • Ability to provide informed consent and complete 12-month follow-up protocol

Exclusion Criteria:

  • Severe cardiopulmonary disease preventing surgery or follow-up
  • Active malignancy
  • Uncontrolled psychiatric illness
  • Inability to comply with follow-up visits
  • Previous abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic Sleeve Gastrectomy (LSG)
Patients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia using the baseball diamond trocar technique, 34-Fr bougie calibration, and linear stapling from 4-6 cm proximal to the pylorus to the angle of His. Standard perioperative care included VTE prophylaxis (enoxaparin 40 mg SC daily ×10 days, sequential compression devices) and methylene blue leak test. Follow-up at 1, 3, 6, and 12 months assessed weight loss, comorbidities, medication use, quality of life, and complications (Clavien-Dindo graded).
Procedure: Laparoscopic 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).
Behavioral: Structured Dietary Counseling
Structured 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
Active Comparator: Conservative Management
Patients aged ≥65 years with BMI ≥40 kg/m² and ≥1 weight-related comorbidity received structured dietary counseling (500-800 kcal deficit by certified nutritionists) plus guideline-directed pharmacotherapy for comorbidities (T2D, HTN, OSA, osteoarthritis) in specialized clinics. No anti-obesity medications (e.g., GLP-1 agonists) were used due to patient refusal related to high cost and lack of insurance coverage. Follow-up at 1, 3, 6, and 12 months assessed weight, comorbidities, medication use, quality of life, and safety.
Behavioral: Structured Dietary Counseling
Structured 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight-related comorbidity status at 12 months
Time Frame: Baseline to 12 months
Proportion of patients with change in comorbidity status at 12 months, including percentage requiring medication for each comorbidity (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, osteoarthritis), medication dose change or discontinuation, and complete resolution of each condition.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index
Time Frame: Baseline to 12 months
Change in BMI (kg/m²) = 12-month BMI - baseline BMI
Baseline to 12 months
Change in HbA1c
Time Frame: Baseline to 12 months
Change in HbA1c (%) in patients with type 2 diabetes mellitus
Baseline to 12 months
Change in systolic blood pressure
Time Frame: Baseline to 12 months
Change in systolic blood pressure (mmHg) in patients with hypertension
Baseline to 12 months
Change in apnea-hypopnea index
Time Frame: Baseline to 12 months
Change in AHI (events/hour) by polysomnography in patients with obstructive sleep apnea
Baseline to 12 months
Change in knee joint space width
Time Frame: Baseline to 12 months
Change in minimum knee joint space width (mm) on standing AP radiographs in patients with osteoarthritis
Baseline to 12 months
Incidence of postoperative complications
Time Frame: Baseline to 12 months
Incidence and Clavien-Dindo grade of complications in LSG arm
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available upon reasonable request from the corresponding author (khaled.elsayed1495@alexmed.edu.eg), as stated in the manuscript.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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