Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01846637
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: laparoscopic sleeve gastrectomy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 cm from pylorus at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus.	Procedure: laparoscopic sleeve gastrectomy
Active Comparator: 6 cm from pylorus at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus	Procedure: laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcome Measures

1. percentage of excess weight loss [2 years]

Secondary Outcome Measures

1. complications [2 years]

Other Outcome Measures

1. improvement of comorbidities [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• morbid obese patients

Exclusion Criteria:

• contraindication to laparoscopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Surgical Center	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdel-Raouf El-Geidie, assistant professor of general surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT01846637
• Other Study ID Numbers: 2013
• First Posted: May 3, 2013
• Last Update Posted: May 6, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of May 6, 2013