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Morbid ObesityFFSINCT01980420

Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

A study testing Laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Morbid Obesity
What is being tested?
Laparoscopic sleeve gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteFrance
Study dates
Nov 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Non-inclusion criteria:
Show all 14Show fewer
  • 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 within exclusion period from other clinical trial
  • Patient having forfeited their freedom of an administrative or legal obligation
  • Patient being under guardianship

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

    Strasbourg, 67000

Other trials in France

About this study

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

Read the detailed description

Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).

Conditions
Morbid Obesity
Being tested
Laparoscopic sleeve gastrectomy
Keywords
Sleeve gastrectomy, Oesogastric junction - GEJ, Dynamic MRI Imaging
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic sleeve gastrectomyProcedure or surgery

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

Study groups in NCT01980420
Study groupRoleWhat they receive
Sleeve gastrectomyOtherAll patients will undergo sleeve gastrectomy
Receives: Procedure: Laparoscopic sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (8)

  1. Quality of life (GIQLI)

    Quality of life (Gastro-Intestinal Quality of Life Index)

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

  2. GERD and dysphagia symptoms (GSAS questionnaire)

    GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale

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

  3. Functional examinations

    Include:

    • Dynamic MRI
    • High resolution manometry
    • pH impedance
    • upper gastro-intestinal study (UGI)

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

  4. EndoFLIP® measures

    Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure

    Measured: Intra-operatively

  5. Surgical video analysis

    Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome

    Measured: within 6 months post surgery

  6. Per and post-operative complications

    Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss)

    Measured: within 6 months post surgery

  7. Cost of exploratory exams

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

  8. Cost of exploratory exams

    Measured: Within 2 months prior to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01980420
Sponsor's protocol ID
13-001
Other IDs
2013-A00723-42
Acronym
FFSI
Status last verified
Aug 2016
First submitted
28 Oct 2013
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32207049

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with postoperative GIQLI score greater than preoperative score (time frame: 50% excess weight loss (about 6 months post surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01980420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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