Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass, with complete objective evaluation of reflux.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring surgery within 2 years prior to inclusion;

Patient in failure of medical treatment;

Weight loss greater than 50% of excess weight;

Disqualifiers

Patient with conversion from one anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux requiring surgery;

Patient with concomitant hiatal hernia correction for one anastomosis gastric bypass ;

Patient with secondary one anastomosis gastric bypass ;

Patient with a deregulated diet;

Trial design

Design model

Single group

Treatments tested in this trial

  • Bypass surgery type one anastomosis gastric bypass

    Procedure/Surgery

    Adult patients who have undergone single-anastomosis gastric bypass followed by fundoplication of the excluded stomach for the treatment of disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgical intervention.

Treatment groups

17 Participants
are divided into 1 treatment group
Group A: Gastroesophageal reflux diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate after Fundoplicature with stomach excluded

The primary endpoint is the long-term efficacy of Fundoplicature with stomach excluded in the treatment of disabling Gastroesophageal Reflux Disease requiring Omega post-bypass surgery after surgery.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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