Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

NCT06298942 — Not applicable, Completed, 250 participants, Minia University

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RegistryNCT06298942
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment250 (Actual)
SponsorMinia University (Other)
ConditionsObesity, Morbid
Interventionsnatural band, silicone band (Procedure)
Datesstart 2024-03-15, primary completion 2025-10-15, completion 2025-11-15, first posted 2024-03-07, last updated 2026-10-19
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
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-Summary

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

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+Detailed description

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost

+Arms and interventions

ArmTypeInterventionsDescription
natural bandExperimentalProcedure: natural bandto use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
silicone bandActive comparatorProcedure: silicone bandto use a synesthetic band with sleeve gastrectomy
  • natural band (Procedure): to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
  • silicone band (Procedure): to use synesthetic band with sleeve gastrectomy

+Outcome measures

Primary outcomes

  • total cost [12 hours]: total operative cost in Egyptian pound (LE)
  • food intolerance [1 year]: food intolerance at one year food tolerance arabic score questionnaire

Secondary outcomes

  • %EWL [1 year]: percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100
  • complications rate [1 year]: the incidence of early and late complications according to Clavien-Dindo (CD)
  • improvement of comorbidities [1 year]: the incidence of improvement of comorbidities

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 65
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

+Locations (1)

FacilityCityCountryStatus
Miinia UniversityMinya, Minya GovernorateEgypt