NCT01980420

Brief Summary

Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

October 28, 2013

Last Update Submit

August 31, 2016

Conditions

Morbid Obesity

Keywords

Sleeve gastrectomyOesogastric junction - GEJDynamic MRI Imaging

Outcome Measures

Primary Outcomes (1)

  • Number of patients with postoperative GIQLI score greater than preoperative score

    Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score

    50% excess weight loss (about 6 months post surgery)

Secondary Outcomes (8)

  • Quality of life (GIQLI)

    50% of excess weight loss (about 6 months post surgery)

  • GERD and dysphagia symptoms (GSAS questionnaire)

    50% of excess weight loss (about 6 months post surgery)

  • Functional examinations

    50% of excess weight loss (about 6 months post surgery)

  • EndoFLIP® measures

    Intra-operatively

  • Surgical video analysis

    within 6 months post surgery

  • +3 more secondary outcomes

Study Arms (1)

Sleeve gastrectomy

OTHER

All patients will undergo sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.

Sleeve gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Patient, male or female over 18 years old
  • Patient scheduled to undergo a sleeve gastrectomy for obesity
  • Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP)
  • Patient able to understand the study and to provide written informed consent
  • Patient registered with the French social security regime
  • Patient unable to give written informed consent
  • Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices)
  • Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium)
  • Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures
  • Patient pregnant or breast-feeding
  • Patient having forfeited their freedom of an administrative or legal obligation
  • Patient being under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related Publications (1)

  • Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.

    PMID: 32207049DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Silvana Perretta, Pr

    Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 11, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-08

Locations

FR(1)