Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000, France
Location status: Recruiting
Location contact
Emeric ABET
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07313293
Obesity is a major public health issue. The Obépi epidemiological survey, the results of which were published in 2020, shows a steady increase in obesity among the French population.
Currently, more than 23 million French people are overweight or obese, and more than 8 million French people are obese. The most effective treatment currently available is surgery. These procedures are governed by specific recommendations. Between 50,000 and 60,000 procedures are performed in France each year. Three procedures are authorised: gastric banding, sleeve gastrectomy and gastric bypass.
Hallyday & al report 65% of patients experiencing nausea/vomiting after bariatric surgery. In 2019, Suh & al showed that nausea and vomiting were more common after sleeve gastrectomy and that they were responsible for an increase in the length of hospitalisation. These episodes of nausea and vomiting occur within 48 hours after sleeve gastrectomy and can cause difficulties in resuming eating. One of the factors contributing to the occurrence of nausea and vomiting was the use of opioids.
The benefits of foot reflexology were reported in 2023 by Dr Carrazé in rectal surgery. His doctoral thesis in medicine showed that foot reflexology sessions on days 1, 2 and 3 following rectal surgery reduced post-operative ileus and post-operative pain. The reduction in post-operative ileus led to a decrease in episodes of nausea and vomiting.
In 2021, Murat-Ringot & al demonstrated the beneficial effect of foot reflexology on nausea and vomiting during chemotherapy sessions, in addition to the anti-emetic treatments used for prevention. Anderson & al. in 2021 also demonstrated a beneficial effect on pain in cancer patients, with no effect on nausea.
The principle of foot reflexology is based on the fact that each organ, gland or part of the body corresponds to a reflex zone on the foot, hand, ears or face. Stimulation of the reflex zones is thought to activate the autonomic nervous system. Currently, there is very little scientific evidence on how this practice works and what its effects are. Despite various scientific publications on the results of foot reflexology, scientific evidence of its effectiveness remains weak. Only one prospective randomised trial has been found in the literature (Dalal & al.) on the quality of life of patients with epilepsy.
Despite the lack of high-quality studies, it appears that foot reflexology could benefit patients by reducing nausea and vomiting. To date, no studies have evaluated its effectiveness in the post-operative period, particularly after bariatric surgery.
The aim of our randomised trial is to evaluate the impact of foot reflexology on nausea and vomiting after sleeve gastrectomy.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
La Roche-sur-Yon, 85000, France
Location status: Recruiting
Emeric ABET
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Foot reflexology sessions to:
Time frame: 24 hours post-operatively
A score of ≥ 3 corresponds to the introduction of treatment.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Departemental Vendee
Other
Acronym: IRANNO
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.
Published trials that share one or more normalized conditions with this study.
NCT06783751
Bariatric Surgery, Body Weight
Orange, California, United States
View Trial DetailsNCT06671639
Bronchoplasty, Cervical and Thoracic Tracheoplasty
Stanford, California, United States
View Trial DetailsNCT04411823
Bariatric Surgery Complication, Deglutition Disorders
Orlando, Florida, United States
View Trial DetailsNCT07397572
Anemia, Anemia, Hypochromic
Cairo, Al-Manial Cairo, Egypt
View Trial Details