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Completed

NCT Number: NCT01980420

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • 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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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

Primary outcomes

  1. Number of patients with postoperative GIQLI score greater than preoperative score

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

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

Secondary outcomes

  1. Quality of life (GIQLI)

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

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

  2. GERD and dysphagia symptoms (GSAS questionnaire)

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

    GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale

  3. Functional examinations

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

    Include:

    • Dynamic MRI
    • High resolution manometry
    • pH impedance
    • upper gastro-intestinal study (UGI)
  4. EndoFLIP® measures

    Time frame: Intra-operatively

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

  5. Surgical video analysis

    Time frame: within 6 months post surgery

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

  6. Per and post-operative complications

    Time frame: within 6 months post surgery

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

  7. Cost of exploratory exams

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

  8. Cost of exploratory exams

    Time frame: Within 2 months prior to surgery

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Acronym: FFSI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2013
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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