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NCT Number: NCT03554902

Endoscopic Gastric Tubulization

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location status: Recruiting

About this study

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.

Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.

One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Treatment and study plan

Endoscopic gastric tubulization

Procedure

Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).

Primary outcomes

  1. Change in weight loss

    Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

    Change in weight loss measured in kilograms.

  2. Change in excess weight loss

    Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

    Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100

  3. Change in body mass index variation

    Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

    Change in body mass index variation measured in kg/m².

Secondary outcomes

  1. Number of patients with procedure-related adverse event

    Time frame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure

    Number of patients with procedure-related adverse event within 12 months after procedure.

  2. Comorbidities improvement

    Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

    Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.

  3. Quality of life improvement

    Time frame: 3 - 12 - 18 and 24 months after procedure

    Improvement of quality of life assessed by Moorehead-Ardelt Quality of Life questionnaire II. Score range from -3.0 to 3.0.

    • Score from -3.0 to -2.1: very poor quality of life
    • Score from -2.0 to -1.1: poor quality of life
    • Score from -1.0 to 1.0: fair quality of life
    • Score from 1.1 to 2.0: good quality of life
    • Score from 2.1 to 3.0: very good quality of life.

  4. Gastro-intestinal quality of life improvement

    Time frame: 3 - 12 - 18 and 24 months after procedure

    Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal.

  5. Modification in the feeling of satiety

    Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure

    Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.

    • Restrained eating: score from 6 to 24
    • Uncontrolled eating: score from 9 to 36
    • Emotional eating: score from 3 to 12.

  6. Upper GI tract radiologic evaluation

    Time frame: 1 day, 6 - 12 and 24 months after procedure

    Upper GI control series.

  7. Upper GI tract endoscopic evaluation

    Time frame: 6 - 12 and 24 months after procedure

    Upper GI control gastroscopy.

  8. Procedure duration

    Time frame: At time of procedure

    Time required to perform the endoscopic gastric tubulization.

  9. Number of stitches in place

    Time frame: At time of procedure

    Number of stitches put in place during the endoscopic gastric tubulization.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Acronym: Endosleeve

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2018
Registry last updated
May 1, 2025

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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