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Completed

NCT Number: NCT04235829

Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.

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Key information

About this study

Patients who underwent laparoscopic sleeve gastrectomy in the 6 month period between 01/04/2012 and 01/10/2019 were identified. For those meeting the inclusion criteria, demographic and medical data was extracted from hospital notes. This included initial BMI and the presence of, or treatment for, diabetes or hypertension.

Using the contact details available in the medical records, a scripted telephone interview was performed. The current weight of the patient as well as a current medical and drug history were elicited. This data was compared with data attained during initial patient interaction with the service.

Early weight loss, defined as weight lost in the 4 weeks following surgery, was subsequently correlated with outcomes in terms of weight loss and improvement/resolution of either hypertension or diabetes at a 7 year follow up interval.

Who can participate

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

Inclusion criteria

  • LSG performed must have been the first surgical procedure performed for that the patient had undergone to treat their obesity
  • Have not undergone any further bariatric surgical procedures since the index operation
  • Still be alive at the time of the study
  • Have correct be contactable with the contact details present available in the electronic database

Exclusion criteria

  • Missing data
  • Uncontactable
  • Unwilling to participate

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Form of obesity surgery

Primary outcomes

  1. Correlation between early % total weight loss and % total weight loss 7 years following surgery.

    Time frame: A comparison made between 4 weeks and 7 years following the index surgery.

    A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.

Secondary outcomes

  1. Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..

    Time frame: A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.

    Reduction / resolution of either hypertension or type 2 diabetes mellitus as defined by a reduction or cessation of medical treatment for the respective comorbidity. Patient diagnoses before surgery were compared with medical and medication histories taken at 7 years follow up.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Predicting Weight Loss and Comorbid Improvement Early Post-operative Weight Loss Fails to Predict Outcomes 7 Years Following Laparoscopic Sleeve Gastrectomy: Does Early Weight Loss Matter

Important dates

Study start
2012
Primary completion
2012
Study completion
2019
First posted
Jan 22, 2020
Registry last updated
Jan 22, 2020

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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