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Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy (LGP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Bikkur Holim Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bikkur Holim Hospital
ClinicalTrials.gov Identifier:
NCT01293877
First received: February 10, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 10, 2011
February 10, 2011
March 2011
March 2012   (final data collection date for primary outcome measure)
Body Mass index loss [ Time Frame: 6mont. ] [ Designated as safety issue: No ]
The body mass index will be compared before the procedure and after at time frames.
Same as current
No Changes Posted
Complications Quality of life [ Time Frame: 6 month ] [ Designated as safety issue: No ]
complications compared one with the second procedure, qol, possibility to eat.
Same as current
Not Provided
Not Provided
 
Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
Laparoscopic Gastric Plication for Treatment of Morbid Obesity

The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.

The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Morbid Obesity
Procedure: Laparoscopy surgery for morbid obesity
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
  • LGP
    Patient underwent surgery for morbid obesity treatment between 18 to 60 years, and BMI of 40 ore more will divided in two groups, one hundred will be schedule for laparoscopic gastric plication. Our theory for this arm is that the procedure can offer the same results than the second arm with less cost and safety, reversibility included.
    Intervention: Procedure: Laparoscopy surgery for morbid obesity
  • LSG
    The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.
    Intervention: Procedure: Laparoscopy surgery for morbid obesity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI 40 or more
  • Age between 18-60 years old
  • ASA score 1-2

Exclusion Criteria:

  • BMI less than 40
  • Severe illness
  • Psychiatric disorders
Both
18 Years to 60 Years
Yes
Contact: Sergio G Susmallian, dr +972524637743 sergio9@bezeqint.net
Contact: Oleg Ponomarenko, dr +972525912710 oleg2308@012.net.il
Israel
 
NCT01293877
GP111BH
No
Sergio Susmallian, Bikkur Holim Hospital
Bikkur Holim Hospital
Not Provided
Principal Investigator: Sergio g Susmallian, dr
Bikkur Holim Hospital
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP