Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reinforcement Method in Laparoscopic Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051919
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
M.Timucin Aydin, Fatih Sultan Mehmet Training and Research Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.

Condition or disease Intervention/treatment
Laparoscopic Sleeve Gastrectomy Other: observation

Detailed Description:

The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.

The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks
Study Start Date : March 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
no reinforcement
Group I: 25 patients; no reinforcement (NoR) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
 Other: observation
fibrin glue
Group II: 26 patients; fibrin glue (FG) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
 Other: observation
suture reinforcement
Group III: 44 patients; suture reinforcement with 2-0 polypropylene suture (S) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
 Other: observation
biological buttressing materaia
Group IV: 14 patients; biological buttressing material Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
 Other: observation


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. assessing prevalence of leaks among different reinforcement methods [ Time Frame: 3 months ]
    observation


Biospecimen Retention:   Samples Without DNA
resected stomachs

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
118 patients with body mass index >40 kg/m2 underwent sleeve gastrectomy and were enrolled into four groups
Criteria

Inclusion Criteria:

  • body mass index >40 kg/m2

Exclusion Criteria:

  • disruption of the resected stomach during extraction from the abdomen.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: M.Timucin Aydin, Attending Surgeon, Department of Surgery, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03051919    
Other Study ID Numbers: FSMTRH
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by M.Timucin Aydin, Fatih Sultan Mehmet Training and Research Hospital:
Laparoscopic sleeve gastrectomy
reinforcement
leak