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

Completed

• Conditions: Hypertension; Weight Loss; Gastrostomy; Morbid Obesity; Diabetes Mellitus, Type 2

• Registration Number: NCT04235829
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-04-01
• Primary Completion: 2012-10-01
• Study Completion: 2019-01
• Study First Submitted: 2019-11-30
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between early % total weight loss and % total weight loss 7 years following surgery.	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 Outcome Measures

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

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel