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Completed

NCT Number: NCT05603338

Naturally Banded Sleeve Gastrectomy

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia university hospital

Minya, 61511, Egypt

About this study

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study
  • previous restrictive bariatric procedure

Exclusion criteria

  • patients unfit for surgery
  • patients aged less than 18 and older than 60
  • patient with previous upper abdominal surgery either for obesity or other diseases

Treatment and study plan

LSG with omental band

Procedure

LSG with omental band

LSG

Procedure

just to do sleeve gastrectomy

Primary outcomes

  1. the effect on weight loss

    Time frame: 12 months

    the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI

  2. the size of gastric pouch at one year

    Time frame: 12 months

    the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study

Secondary outcomes

  1. the effect on comorbidities

    Time frame: 12 monthts

    change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

  2. operative time

    Time frame: 6 hours

    operative time in minutes from skin incision to skin closure

  3. the incidences of complications

    Time frame: 12 monthss

    the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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