Abstract
Background
Currently, Roux-en-Y gastric bypass (RYGB) is one of the most widely used bariatric surgeries. Banding the pouch forms a banded gastric bypass operation, an accepted and frequently used variant. Placing a silastic ring around the pouch to band the gastric bypass operation increases the restriction mechanism. However, the ubiquitous use of the banded gastric bypass remains controversial. One of the controversies is the effect of the silastic ring on patients’ perception of their well being after surgery because of the frequency of vomiting. A prospective, blindly randomized, comparative trial was undertaken to resolve this controversy.
Method
Four hundred subjects scheduled for gastric bypass surgery were randomized into two arms of the trial, 200 with a silastic ring (WR) and 200 without (NR). After 2-year follow-up, the variables associated with the scores of Bariatric Analysis and Reporting Outcome System (BAROS) were analyzed.
Results
The initial median weight (125 kg), BMI (47), and age (36 years) were the same in both the NR and WR groups. The median excess weight loss, weight regain, and incidence of vomiting were 71, 10.5, and 7.75 %, respectively, in the NR group vs. 75.4 and 1.1, and 24.4 % in the WR group. The mean QOL score was 79 % in the NR group vs. 80 % in the WR group.
Conclusion
After 2-year follow-up, silastic ring placement in the RYGB resulted in greater weight loss and weight stability and a threefold greater incidence of vomiting. There was no difference in the scores in the quality of life analysis.
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Ministério da Saúde do Brasil. Portaria n. 424 de 19/03/2013. In: Gabinete do Ministro, editor. Diário Oficial da União 2013.
Conflict of Interest
A summary statement: IRINEU RASERA JUNIOR is Ethicon J&J proctorship.
Ethical Approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed Consent
Informed consent was obtained from all individual participants included in the study.
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Rasera, I., Coelho, T.H., Ravelli, M.N. et al. A Comparative, Prospective and Randomized Evaluation of Roux-en-Y Gastric Bypass With and Without the Silastic Ring: A 2-Year Follow Up Preliminary Report on Weight Loss and Quality of Life. OBES SURG 26, 762–768 (2016). https://doi.org/10.1007/s11695-015-1851-z
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DOI: https://doi.org/10.1007/s11695-015-1851-z