NCT02878525

Brief Summary

The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

August 21, 2016

Last Update Submit

January 31, 2018

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • safety of the technique

    the incidence of introperative and early postoperative complications

    4 weeks

Secondary Outcomes (4)

  • operative time

    12 hours

  • Hospital stay

    30 days

  • total cost

    16 weeks

  • Metabolic effect

    6-12 months

Study Arms (2)

Laparoscopic internal gastric banding

EXPERIMENTAL

Laparoscopic internal gastric banding

Procedure: Laparoscopic internal gastric banding

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Laparoscopic sleeve gastrectomy

Procedure: laparoscopic sleeve gastrectomy

Interventions

Laparoscopic internal gastric bandingPROCEDURE

Laparoscopic internal gastric banding

Laparoscopic internal gastric banding
laparoscopic sleeve gastrectomyPROCEDURE

laparoscopic sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
  • Approval to share in the study
  • Patients fit for laparoscopic surgery

You may not qualify if:

  • Patient age less than 18 or more than 50 years old
  • Refusal to share in the study
  • Unfit for surgery
  • patients with gastroesophageal reflux disease clinically or by investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of medicine

Minya, 61511, Egypt

Location

Minia university hospital

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Study Record Dates

First Submitted

August 21, 2016

First Posted

August 25, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

EG(2)