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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235829
• Other study ID #: SZMC-95/19
• Status: Completed
• Start date: April 1, 2012
• Est. completion date: January 2019

Study information

• Verified date: January 2020
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2019
• Est. primary completion date: October 1, 2012
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gastrostomy
• Hypertension
• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Form of obesity surgery

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between early % total weight loss and % total weight loss 7 years following surgery.	A correlation between % total weight loss 4 weeks following surgery and % total weight loss at 7 years follow up based on clinic measurements.	A comparison made between 4 weeks and 7 years following the index surgery.
Secondary	Reduction or cessation in the treatment for either type 2 diabetes mellitus and hypertension 7 years following surgery..	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.	A comparison was made between pre-operative medical / medication histories and equivalent data at 7 years follow up.