Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity

Sleeve Gastrectomy With Jejunoileal Anastomosis Clinical Trial

Official title:

Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939442
• Other study ID #: 2019/3-10
• Status: Completed
• Start date: February 10, 2019
• Est. completion date: May 3, 2019

Study information

• Verified date: May 2019
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Laparoscopic sleeve gastrectomy operations performed for morbid obesity are among the most common methods in the world. Gastric or intestinal bypass surgery with or without sleeve gastrectomy is thought to be more effective in controlling both weight loss and metabolic diseases. For this purpose, Roux-en-y gastric bypass, transit bipartition, duodenal switch, jejunoileal bypass are performed. The aim of this study was to evaluate the effects of jejunoileal bypass surgery on weight loss and metabolic diseases in patients with sleeve gastrectomy.

Description:

Bariatric surgery results in more and more long-term weight loss than traditional treatment in moderate and severe obesity. Due to morbid obesity, jejunoileal bypass has been applied since 1970. Laparoscopic sleeve gastrectomy and jejunoileal anastomosis are among the rare techniques described in 2012. There are few studies on this technique.

Between 2015 and 2018, jejunoileal bypass operations with laparoscopic sleeve gastrectomy for morbid obesity will be evaluated in Inonu University gastroenterology surgery clinic. The patients' age, gender, body mass index, weight loss in follow-up periods, whether there is back weight gain, the effects on metabolic diseases, early and late complications will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:All patients who underwent the sleeve gastrectomy with jejunoileal bypass between 2015-2018 for the treatment morbid obesity

Exclusion Criteria:other operations for morbid obesity except sleeve gastrectomy with jejunoileal bypass

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Sleeve Gastrectomy With Jejunoileal Anastomosis

Intervention

Procedure:
• Sleeve gastrectomy with jejunoileal anastomosis
The sleeve gastrectomy was performed first, after using a sealer and divider device to dissect the omentum away from the greater gastric curvature from approximately 5 cm proximal to the pylorus up to the angle of His. Excision of the fundus and the body of the stomach was then performed with a laparoscopic linear stapler upon a 36 French orogastric tube (bougie). An isoperistaltic side-to-side anastomosis between the jejunum (at 50 cm distal to the Treitz ligament) and the distal ileum ( at 200 cm proximal to the ileocecal valve) was then created using the same linear stapler with a blue cartridge (3.5 mm). A soft Penrose drain was left at the subdiaphragmatic space, and the abdominal wound was closed.

Locations

Country	Name	City	State
Turkey	Cihan Gökler	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss	body mass index (BMI) 25 was considered ideal. The ratio of the value above this value to the value that arrived at the end of 2 years was calculated. Over 80% was considered successful.	2 years
Primary	diabetes remission	Complete remission absence antidiabetic medications, HbA1c level below 6%, fasting blood glucose value below 100 mg / dl; partial remission Subdiabetic hyperglycemia (HbA1c 6%-6.4%, FBG 100-125 mg/dL) in the absence antidiabetic medications; Unchanged The absence of remission or improvement as described earlier	2 years