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Laparoscopic fundoplication versus laparoscopic Roux-en-Y gastric bypass for gastro-oesophageal reflux disease in obese patients: protocol for a randomized clinical trial. 2022

Adam Frankel, and Iain Thomson, and Ayesha Shah, and Chen Chen, and Syeda Farah Zahir, and Andrew Barbour, and Gerald Holtmann, and B Mark Smithers
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.

Laparoscopic fundoplication (LF) is the standard surgical procedure for the treatment of gastro-oesophageal reflux disease (GORD). Laparoscopic Roux-en-Y gastric bypass (LRYGB) is commonly performed to achieve weight loss in obese patients, but it also has anti-reflux properties. Hence, in the obese population suffering from GORD, LRYGB could be an alternative to LF. The aim of this trial will be to compare LF and LRYGB in an obese population presenting with GORD and being considered for surgery. This will be an investigator-initiated randomized clinical trial. The research population will be obese patients (BMI 30-34.9 with waist circumference more than 88 cm (women) or more than 102 cm (men), or BMI 35-40 with any waist circumference) referred to a public hospital for consideration of anti-reflux surgery. The primary aim of the study will be to determine the efficacy of LF compared with LRYGB on subjective and objective control of GORD. Secondary aims include determining early and late surgical morbidity and the side-effect profile of LF compared with LRYGB and to quantify any non-reflux benefits of LRYGB (including overall quality of life) compared with LF. This trial will determine whether LRYGB is effective and acceptable as an alternative to LF for the surgical treatment of GORD in obese patients Registration number: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000636752p (https://www.anzctr.org.au/).

UI MeSH Term Description Entries
D008297 Male Males
D009765 Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).
D010535 Laparoscopy A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY. If appropriate, biopsy or surgery can be performed during laparoscopy. Celioscopy,Laparoscopic Surgical Procedures,Peritoneoscopy,Surgical Procedures, Laparoscopic,Laparoscopic Assisted Surgery,Laparoscopic Surgery,Laparoscopic Surgical Procedure,Procedure, Laparoscopic Surgical,Procedures, Laparoscopic Surgical,Surgery, Laparoscopic,Surgical Procedure, Laparoscopic,Celioscopies,Laparoscopic Assisted Surgeries,Laparoscopic Surgeries,Laparoscopies,Peritoneoscopies,Surgeries, Laparoscopic,Surgeries, Laparoscopic Assisted,Surgery, Laparoscopic Assisted
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D005260 Female Females
D005764 Gastroesophageal Reflux Retrograde flow of gastric juice (GASTRIC ACID) and/or duodenal contents (BILE ACIDS; PANCREATIC JUICE) into the distal ESOPHAGUS, commonly due to incompetence of the LOWER ESOPHAGEAL SPHINCTER. Esophageal Reflux,Gastro-Esophageal Reflux Disease,GERD,Gastric Acid Reflux,Gastric Acid Reflux Disease,Gastro-Esophageal Reflux,Gastro-oesophageal Reflux,Gastroesophageal Reflux Disease,Reflux, Gastroesophageal,Acid Reflux, Gastric,Gastro Esophageal Reflux,Gastro Esophageal Reflux Disease,Gastro oesophageal Reflux,Gastro-Esophageal Reflux Diseases,Reflux Disease, Gastro-Esophageal,Reflux, Gastric Acid,Reflux, Gastro-Esophageal,Reflux, Gastro-oesophageal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001315 Australia The smallest continent and an independent country, comprising six states and two territories. Its capital is Canberra. Canton and Enderbury Islands,Christmas Island,Christmas Island (Australia)
D015390 Gastric Bypass Surgical procedure in which the STOMACH is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the SMALL INTESTINE by an end-to-side SURGICAL ANASTOMOSIS, depending on the amounts of intestinal surface being bypasses. This procedure is used frequently in the treatment of MORBID OBESITY by limiting the size of functional STOMACH, food intake, and food absorption. Gastroileal Bypass,Gastrojejunostomy,Greenville Gastric Bypass,Roux-en-Y Gastric Bypass,Bypass, Gastric,Bypass, Gastroileal,Bypass, Roux-en-Y Gastric,Gastric Bypass, Greenville,Gastric Bypass, Roux-en-Y,Gastrojejunostomies,Roux en Y Gastric Bypass
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical

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