About this trial
Laparoscopic gastric bypass - including both Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB) - is one of the most frequently performed procedures. However, as the number of gastric bypass surgeries increases, complications are being reported more often. While most post-bypass complications can be managed non-surgically, a small number of persistent cases may require a reversal to normal anatomy or conversion to another procedure.
Many patients who experience severe complications from gastric bypass are reluctant to undergo a reversal to normal anatomy due to fears of regaining weight. As a result, converting to another type of surgery becomes a more logical alternative.
Complications requiring conversion are numerous and negatively affect the quality of life, such as retrograde intussusception, weight regain, intractable dumping syndrome, and nutritional deficiencies. The high cost of obligatory postoperative vitamins is a potential cause of conversion especially in low-income countries.
The conversion procedure is technically demanding and has a relatively higher rate of postoperative complications, making it less commonly performed. Additionally, limited data is available regarding the procedure and its long-term outcomes, making it an unexplored sea of hope for people who wish to manage intractable complications of gastric bypass and maintain weight loss.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-70
Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy.
Patients accept to sign an informed consent and will commit to follow-up.
Disqualifiers
Patients with reversal gastric bypass to normal anatomy.
Patient with uncontrolled systemic disease.
Patients with active psychological disorders.
Patients with active substance abuse.
Trial design
Single group
Treatments tested in this trial
Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.
Procedure/SurgeryThis research entails a single-stage laparoscopic conversion of gastric bypass to sleeve gastrectomy. The procedure entails the closure of the gastrojejunostomy with an endo-stapler and the reconstruction of the stomach by resecting along the greater curvature to create a sleeve gastrectomy. An intraoperative leak test will be conducted using methylene blue. Patients are monitored postoperatively for at least 24 hours, with subsequent assessments of nutritional status, weight, gastroesophageal reflux disease (GERD) symptoms, and quality of life at 3 and 6 months.
Treatment groups
Trial outcomes
Primary outcomes
Nutritional Status
nutritional status of patient will be assessed by general examination, assessment of lower limb edema, serum albumin and hemoglobin
Weight Regain
The initial weight at the time of the procedure will be measured in kg, and at follow-up, it will be reassessed at three, six, and twelve months. Weight assessment will be part of the BMI assessment in kg/m2
Secondary outcomes
Quality of Life
The Short Form 36 (SF-36) questionnaire will be used to assess quality of life and overall health status.
GERG symptoms
GERD symptoms will be assessed at three, six, and twelve months of follow-up. The GERD-Health Related Quality of Life (GERD-HRQL) Questionnaire will be used in this study.
Other outcomes
Possible Risks
1. Post operative pain. 2. Post operative nausea and vomiting. 3. Bleeding 4. Anastomotic leakage 5. Stricture
Sponsors and contacts
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