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Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients. (LGCP)

11 maart 2012 bijgewerkt door: Kuldeep Singh, Singh, Kuldeep, M.D., P.A.

Laparoscopic Greater Curvature Plication for Weight Loss and Resolution of Diabetes and Other Comorbidities.

Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .

Studie Overzicht

Toestand

Onbekend

Conditie

Obesitas

Interventie / Behandeling

Procedure: Laparoscopic Greater Curvature Plication

Gedetailleerde beschrijving

Since the acceptance of surgical procedures to achieve a sustainable weight loss, many different procedures has been tried with variable success. Among them , various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Currently, laparoscopic adjustable gastric band ( LAGB) and sleeve gastrectomy are being used with variable acceptance and success. Laparoscopic gastric plication or laparoscopic greater curvature plication ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

A prospective nonrandomized study at Cleveland clinic suggested that a reduction in gastric capacity can be achieved by way of plication of stomach and thereby achieving encouraging weight loss. We intend to study this procedure as an alternative to LAGB or sleeve gastrectomy for carefully selected patients. The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss . The subjects will be followed up post operatively to observe the effect on the comorbidities along with sustained weight loss. The inclusion and exclusion criteria , target population, duration of subject participation and primary endpoints will be defined and all the data will be recorded per protocol.

Studietype

Ingrijpend

Inschrijving (Verwacht)

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Maryland
  - Baltimore, Maryland, Verenigde Staten, 21229
    - Werving
    - Saint Agnes Hospital
    - Contact:
      
      Kuldeep Singh, MD
      
      Telefoonnummer: 301-490-3736
      
      E-mail: lapman21229@yahoo.com
    - Contact:
      
      Isam Hamdallah, MD
      
      Telefoonnummer: 301-490-2193
      
      E-mail: galag50@hotmail.com
    - Onderonderzoeker:
      
      Isam Hamdallah, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Subject is willing to give consent and comply with evaluation and treatment schedule;
18 to 65 years of age (inclusive);
Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be limited to -
- Hyperlipidemia
- Type 2 diabetes
- Mild obstructive sleep apnea
- Hypertension
- Osteoarthritis of the hip or knee
Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
HbA1C < 11%
For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
Ability to self pay for the procedure and follow up.

Exclusion Criteria:

Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
Any condition which precludes compliance with the study;
History or presence of pre-existing autoimmune connective tissue disease
Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: NVT
Interventioneel model: Opdracht voor een enkele groep
Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percent excess weight loss Tijdsspanne: 3 years	The percent excess weight loss at 3-years from the time of surgery. The primary analysis will include all available data at the 3-year follow-up.	3 years

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Resolution of comorbidities Tijdsspanne: 3 years	The following comorbidities will be assessed at regular intervals: diabetes, dyslipidemia, liver dysfunction, and hypertension. Measures will include glycosylated hemoglobin, triglycerides, low-density lipoprotein, high-density lipoprotein, serum albumin, liver transaminases, systolic and diastolic blood pressures.	3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Singh, Kuldeep, M.D., P.A.

Onderzoekers

Hoofdonderzoeker: Kuldeep Singh, MD, Kuldeep Singh, MDPA

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2011

Primaire voltooiing (Verwacht)

1 oktober 2012

Studie voltooiing (Verwacht)

1 oktober 2014

Studieregistratiedata

Eerst ingediend

15 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria