NCT02077517

Brief Summary

The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

7 years

First QC Date

February 24, 2014

Last Update Submit

March 2, 2014

Conditions

Morbid Obesity

Keywords

Roux en Y Gastric BypassPostoperative complicationsHand sewn anastomosisStapled anastomosis

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    To compare postoperative complications after bariatric surgery between stapled anastomosis and hand sewn anastomosis

    within the first month after surgery

Secondary Outcomes (2)

  • hospital stay

    within the first month after surgery

  • % of excess weight lost

    five years after surgery

Other Outcomes (1)

  • operative time

    during surgical procedure

Study Arms (2)

hand sewn anastomosis

ACTIVE COMPARATOR

Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing

Procedure: Roux en Y Gastric Bypass

stapled anastomosis

ACTIVE COMPARATOR

Patients with stapled anastomosis during Roux en Y Gastric Bypass performing

Procedure: Roux en Y Gastric Bypass

Interventions

Roux en Y Gastric BypassPROCEDURE
hand sewn anastomosisstapled anastomosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 years
  • absence of previous bariatric surgery

You may not qualify if:

  • less than 18 years old
  • coagulation disorders or liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidPostoperative Complications

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bariatric Surgery unit

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 4, 2014

Study Start

January 1, 2007

Primary Completion

January 1, 2014

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

ES(1)