Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy: 5-year outcomes of merged data from two randomized clinical trials (SLEEVEPASS and SM-BOSS).


Journal

The British journal of surgery
ISSN: 1365-2168
Titre abrégé: Br J Surg
Pays: England
ID NLM: 0372553

Informations de publication

Date de publication:
27 01 2021
Historique:
received: 14 06 2020
revised: 03 08 2020
accepted: 01 09 2020
entrez: 28 2 2021
pubmed: 1 3 2021
medline: 27 4 2021
Statut: ppublish

Résumé

Laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB) are both effective surgical procedures to achieve weight reduction in patients with obesity. The trial objective was to merge individual-patient data from two RCTs to compare outcomes after LSG and LRYGB. Five-year outcomes of the Finnish SLEEVEPASS and Swiss SM-BOSS RCTs comparing LSG with LRYGB were analysed. Both original trials were designed to evaluate weight loss. Additional patient-level data on type 2 diabetes (T2DM), obstructive sleep apnoea, and complications were retrieved. The primary outcome was percentage excess BMI loss (%EBMIL). Secondary predefined outcomes in both trials included total weight loss, remission of co-morbidities, improvement in quality of life (QoL), and overall morbidity. At baseline, 228 LSG and 229 LRYGB procedures were performed. Five-year follow-up was available for 199 of 228 patients (87.3 per cent) after LSG and 199 of 229 (87.1 per cent) after LRYGB. Model-based mean estimate of %EBMIL was 7.0 (95 per cent c.i. 3.5 to 10.5) percentage points better after LRYGB than after LSG  (62.7 versus 55.5 per cent respectively; P < 0.001). There was no difference in remission of T2DM, obstructive sleep apnoea or QoL improvement; remission for hypertension was better after LRYGB compared with LSG (60.3 versus 44.9 per cent; P = 0.049). The complication rate was higher after LRYGB than LSG (37.2 versus 22.5 per cent; P = 0.001), but there was no difference in mean Comprehensive Complication Index value (30.6 versus 31.0 points; P = 0.859). Although LRYGB induced greater weight loss and better amelioration of hypertension than LSG, there was no difference in remission of T2DM, obstructive sleep apnoea, or QoL at 5 years. There were more complications after LRYGB, but the individual burden for patients with complications was similar after both operations.

Sections du résumé

BACKGROUND
Laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB) are both effective surgical procedures to achieve weight reduction in patients with obesity. The trial objective was to merge individual-patient data from two RCTs to compare outcomes after LSG and LRYGB.
METHODS
Five-year outcomes of the Finnish SLEEVEPASS and Swiss SM-BOSS RCTs comparing LSG with LRYGB were analysed. Both original trials were designed to evaluate weight loss. Additional patient-level data on type 2 diabetes (T2DM), obstructive sleep apnoea, and complications were retrieved. The primary outcome was percentage excess BMI loss (%EBMIL). Secondary predefined outcomes in both trials included total weight loss, remission of co-morbidities, improvement in quality of life (QoL), and overall morbidity.
RESULTS
At baseline, 228 LSG and 229 LRYGB procedures were performed. Five-year follow-up was available for 199 of 228 patients (87.3 per cent) after LSG and 199 of 229 (87.1 per cent) after LRYGB. Model-based mean estimate of %EBMIL was 7.0 (95 per cent c.i. 3.5 to 10.5) percentage points better after LRYGB than after LSG  (62.7 versus 55.5 per cent respectively; P < 0.001). There was no difference in remission of T2DM, obstructive sleep apnoea or QoL improvement; remission for hypertension was better after LRYGB compared with LSG (60.3 versus 44.9 per cent; P = 0.049). The complication rate was higher after LRYGB than LSG (37.2 versus 22.5 per cent; P = 0.001), but there was no difference in mean Comprehensive Complication Index value (30.6 versus 31.0 points; P = 0.859).
CONCLUSION
Although LRYGB induced greater weight loss and better amelioration of hypertension than LSG, there was no difference in remission of T2DM, obstructive sleep apnoea, or QoL at 5 years. There were more complications after LRYGB, but the individual burden for patients with complications was similar after both operations.

Identifiants

pubmed: 33640917
pii: 6031379
doi: 10.1093/bjs/znaa011
doi:

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

49-57

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Auteurs

B K Wölnerhanssen (BK)

St Clara Research Ltd, St Clara Hospital, Basle, Switzerland.
University of Basle, Basle, Switzerland.

R Peterli (R)

University of Basle, Basle, Switzerland.
Clarunis, Department of Visceral Surgery, University Centre for Gastrointestinal and Liver Diseases, St Clara Hospital and University Hospital Basle, Basle, Switzerland.

S Hurme (S)

Department of Biostatistics, University of Turku, Turku, Finland.

M Bueter (M)

Department of Visceral and Transplantation Surgery, University Hospital, Zürich, Switzerland.

M Helmiö (M)

Department of Digestive Surgery, Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
Department of Surgery, University of Turku, Turku, Finland.

A Juuti (A)

Department of Abdominal Surgery, Abdominal Centre, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

A C Meyer-Gerspach (AC)

St Clara Research Ltd, St Clara Hospital, Basle, Switzerland.
University of Basle, Basle, Switzerland.

M Slawik (M)

Department of Internal Medicine and Endocrinology, St. Clara Hospital, Basle, Switzerland.

P Peromaa-Haavisto (P)

Department of Surgery, Vaasa Central Hospital, Vaasa, Finland.
Department of Surgery, Hatanpää City Hospital, Tampere, Finland.

P Nuutila (P)

Department of Endocrinology, Turku University Hospital, Turku, Finland.
Turku PET Centre, University of Turku, Turku, Finland.

P Salminen (P)

Department of Digestive Surgery, Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
Department of Surgery, University of Turku, Turku, Finland.
Department of Surgery, Satasairaala Central Hospital, Pori, Finland.

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