Objective: Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium). Design: Eligible patients (body mass index 30-40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG. Results: Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%. Conclusions: This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment. Trial registration number: NCT03255005.

Huberty, V., Boskoski, I., Bove, V., Van Ouytsel, P., Costamagna, G., Barthet, M. A., Deviere, J., Endoscopic sutured gastroplasty in addition to lifestyle modification: Short-term efficacy in a controlled randomised trial, <<GUT>>, 2020; (ottobre): N/A-N/A. [doi:10.1136/gutjnl-2020-322026] [https://hdl.handle.net/10807/221950]

Endoscopic sutured gastroplasty in addition to lifestyle modification: Short-term efficacy in a controlled randomised trial

Boskoski, Ivo;Bove, Vincenzo;Costamagna, Guido;
2020

Abstract

Objective: Endoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium). Design: Eligible patients (body mass index 30-40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG. Results: Of the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%. Conclusions: This study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment. Trial registration number: NCT03255005.
2020
Inglese
GUT
Huberty, V., Boskoski, I., Bove, V., Van Ouytsel, P., Costamagna, G., Barthet, M. A., Deviere, J., Endoscopic sutured gastroplasty in addition to lifestyle modification: Short-term efficacy in a controlled randomised trial, <<GUT>>, 2020; (ottobre): N/A-N/A. [doi:10.1136/gutjnl-2020-322026] [https://hdl.handle.net/10807/221950]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10807/221950
Citazioni
  • ???jsp.display-item.citation.pmc??? 8
  • Scopus 18
  • ???jsp.display-item.citation.isi??? 17
social impact