Reinforcement Method in Laparoscopic Sleeve Gastrectomy

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03051919
• Collaborator: (none)
• Enrollment: 118
• Duration (Months): 7

Study Details

Study Description

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	Phase
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

• 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: Mar 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	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

Primary Outcome Measures

1. assessing prevalence of leaks among different reinforcement methods [3 months]

   observation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• body mass index >40 kg/m2

Exclusion Criteria:

• disruption of the resected stomach during extraction from the abdomen.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fatih Sultan Mehmet Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 14, 2017
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by M.Timucin Aydin, Attending Surgeon, Department of Surgery, Fatih Sultan Mehmet Training and Research Hospital: Laparoscopic sleeve gastrectomy; reinforcement; leak

Study Results

No Results Posted as of Feb 23, 2017