Trial document




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  DRKS00019016

Trial Description

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Title

Quality assurance in bariatric surgery:
Does the size of the cartridge of linear stapled gastro-jejunostomy in gastric bypass patients influence weight loss?

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Trial Acronym

30GJ45-trial

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URL of the Trial

http:///

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Brief Summary in Lay Language

Morbid obesity is global disease, which leads to several other diseases. If non surgical treatment to lose weight fails, bariatric surgical approaches were used to obtain weight loss.

Gastric bypass is surgery that helps lose weight by changing how the stomach and small intestine handle the food.
After the surgery, the stomach is smaller.

Currently it is not clear, which size of stomach-small intestine connection is the best in terms of weight loss.

The trial at hand is comparing two different sizes of stomach-small intestine connection.

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Brief Summary in Scientific Language

The prevalence of morbid obesity is increasing globally. According to the World Health Organization (WHO) more than 1.9 billion adults (≥18 years) were overweight in 2014.
Overweight and obesity are associated with increased risk of morbidity and mortality. Due to limited success of nonsurgical weight loss strategies the role and demand of bariatric surgery for morbid obesity is increasing. Several surgical techniques including laparoscopic Roux-en-Y gastric bypass have been proven to provide sufficient weight loss and reduction of obesity-related comorbidities like Type II Diabetes and Hypertension.
Currently the optimal size of the Gastrojejunostomie, when performing a laparoscopic Roux-en-Y gastric bypass, and its impact on weight loss are not well known due to a lack of evidence. We aimed to provide evidence on the impact of the Gastrojejunostomie size comparing a 30 mm with a 45 mm sized Anastomosis in terms of gastric bypass weight loss.
Currently international and national guidelines give no recommendations concerning the size.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019016
  •   2019/10/22
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   17/19, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   E66.02 -  [generalization E66.0: Obesity due to excess calories]
  •   E66.01 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   Patients who underwent laparoscopic Roux-en-Y Gastric bypass reveived a 30 mm sized gastro-jejunostomy.
  •   Patients who underwent laparoscopic Roux-en-Y Gastric bypass reveived a 45 mm sized gastro-jejunostomy.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Weight loss after 36 month

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Secondary Outcome

Amount of patients with weight loss more than 50 % of the initial, preoperative weight

Amount of patients with weight loss less than 25 % of the initial, preoperative weight

Amount of patients with no weight loss after surgery

Postoperative complication according to Clavien-Dindo-Classification

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/29
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients who underwent bariatric surgery (Gastric Bypass) with appropriate indication according to national guidelines

Age 18 and older

Subscribed patients consent form

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Exclusion Criteria

Age under 18

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Klinikum Berlin-Buch
    • Mr.  Dr. med.  Christoph  Paasch 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.