None listed
Conditions
Brief summary
Laparoscopic Fundoplication (LF) is the gold 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 is an attractive alternative to LF and indeed is recommended in some national and international guidelines despite there being no randomised trials comparing the two procedures to provide efficacy data (subjective or objective), either in normal, overweight or obese patients. The aim of this trial is to compare LF and LRYGB in an obese population presenting for consideration of surgical correction of GORD.
Interventions
Laparoscopic Roux-en-Y gastric bypass
The operation will be performed by or under the direct supervision of a consultant upper gastrointestinal surgeon. The patient will be supine or placed in lithotomy position. Four laparoscopic ports and an epigastric retractor will be placed. A dissection of the oesophageal hiatus will be performed, preserving both vagus nerves, and a cruroplasty will be performed as required using non-absorbable sutures. Crural dissection, cruroplasty and fixation of the d
Laparoscopic Roux-en-Y gastric bypass The operation will be performed by or under the direct supervision of a consultant upper gastrointestinal surgeon. The patient will be supine or placed in lithotomy position. Four laparoscopic ports and an epigastric retractor will be placed. A dissection of the oesophageal hiatus will be performed, preserving both vagus nerves, and a cruroplasty will be performed as required using non-absorbable sutures. Crural dissection, cruroplasty and fixation of the distal oesophagus and gastric pouch will be performed as required. Dissection at the mid-lesser curve and at the cardia will allow an assessment of the lesser sac, with successive stapler firings to create a small gastric pouch. The gastric pouch will be calibrated using a 34Fr bougie and a target length of 7cm. The gastrocolic omentum may be split vertically at the surgeon’s discretion to allow safe delivery of the small bowel. The jejunum will be divided to give a biliopancreatic limb length of approximately 70cm. The alimentary limb will be measured to a length of 70-120cm (tailored by the surgeon to the patient’s BMI). The anastomotic technique used will be at the operating surgeon’s discretion but will be recorded for possible future analyses. The mesenteric defect and Peterson’s space will be closed with non-absorbable suture. The operation will take approximately 2 hours.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Aged greater than or equal to 18 years and less than or equal to 70 years All genders Troublesome symptoms despite maximal medical therapy with 24h pH monitoring (+/- impedence study if locally available) supportive of the diagnosis BMI 30-34.9 with waist circumference >88cm (women) or >102cm (men) BMI 35-40 with any waist-circumference Able and willing to give written consent Willing to perform the questionnaires, investigations and post-operative follow-up required for this study Able to access regular medical care (in the event of post-operative complication such as internal hernia, and for nutritional screening and supplementation measures) Suitable for either surgery
Exclusion criteria
Intra-thoracic stomach (hiatus hernia with >50% of stomach in thorax) Previous gastro-oesophageal surgery (bariatric, anti-reflux, ulcer, motility disorder) Multiple surgeries in abdominal cavity or previous small bowel pathology or resection Clinical or manometry findings concerning for a severe oesophageal dysmotility syndrome (recognising that clinically silent manometry-defined motility disorders are common in obesity) Any medical condition deemed by an investigator to render the patient ineligible (e.g. conditions that may be exacerbated by gastric bypass surgery such as osteoporosis) Inflammatory bowel disease Pregnant or lactating female (routine pre-operative pregnancy test for all female patients with child-bearing potential) Endocrine cause of obesity Current smoker Drug or alcohol abuse Psychological disorders (e.g. bulimia, depression)
Outcome results
None listed