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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03939442

Recruitment Status Completed

First Posted May 6, 2019

Last update posted October 1, 2019

Study Description

Brief 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.

  • Condition or Disease:Sleeve Gastrectomy With Jejunoileal Anastomosis
  • Intervention/Treatment: Procedure: Sleeve gastrectomy with jejunoileal anastomosis
  • Phase: N/A
Detailed 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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 2 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Evaluation of Patients Who Underwent Sleeve Gastrectomy With Jejunoileal Anastomosis for the Treatment of Morbid Obesity
  • Actual Study Start Date: February 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019
Outcome Measures
  • Primary Outcome Measures: 1. Excess weight loss [ Time Frame: 2 years ]
    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. diabetes remission [ Time Frame: 2 years ]
    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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Patients aged between 18 and 60 years with a body mass index greater than 40, no comorbidity or a body mass index of 35-40, with a comorbidity (diabetes mellitus, hypertension, obstructive sleep apnea)
Criteria

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

Contacts and Locations
Contacts
Locations

Turkey
Cihan Gökler
Malatya

Sponsors and Collaborators

Inonu University

More Information
  • Responsible Party: Inonu University
  • ClinicalTrials.gov Identifier: NCT03939442 History of Changes
  • Other Study ID Numbers: 2019/3-10
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: October 1, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Inonu University: obesity, diabetes mellitus, bariatric surgery
  • Additional relevant MeSH terms: Obesity Obesity, Morbid