NCT Number: NCT07038148
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Cairo, Old Cairo, 11956, Egypt
Location status: Recruiting
Ahmed M Abdelatif, Doctorate
SUB_INVESTIGATOR
Ahmed M Ghobashy, Doctorate
SUB_INVESTIGATOR
Ahmed Y Khaled, Doctor
SUB_INVESTIGATOR
Maher Fawzy, Doctorate
CONTACT
Objectives: To study efficacy, safety, and patient outcomes following laparoscopic gastric bypass conversion to sleeve gastrectomy.
Study population & Sample size :
Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in Kasr Alainy Sample size: 11 patients Study Design: This is a prospective single-arm clinical trial.
Methods: Patients who will attend our bariatric outpatient clinic will be enlisted according to inclusion criteria. A detailed history of anthropometric measures, chronic diseases, and previous surgeries will be recorded. After patient education, preoperative routine labs and imaging will be performed.
A preoperative 3D gastric volumetry CT scan will be performed to all patients included in this study.
The procedure will consist of converting the gastric bypass to a sleeve gastrectomy using a stapling technique.
The average length of hospital stay will be included. Follow up of nutritional status will be done using laboratory parameters (Hb, Ferritin, Vitamin D, Zn, Mg, serum Albumin, Calcium) in 3 months and 6 months postoperatively, quality of life will be assessed using bariatric quality of life index in 3 months and 6 months postoperatively.
Patient weight will be documented monthly to evaluate weight regain, GERD symptoms will be assessed using GERD score in 3 months and 6 months postoperatively.
Possible Risk (s) to study population:
Outcome parameters:
Statistical analysis plan:
Data analysis packages will be SPSS version 21. Qualitative data will be presented by number and percentage, quantitative data will be presented by mean, standard deviation, median, and interquartile range.
Parametric and non-parametric tests of significant will be done (chi-square, student t-test, and Mann-Whitney test).
Correlation analysis tests and regression will be done. The level of significance was set at p equal to or below 0.05.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This 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.
Time frame: one year
nutritional status of patient will be assessed by general examination, assessment of lower limb edema, serum albumin and hemoglobin
Time frame: one year
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
Time frame: one year
The Short Form 36 (SF-36) questionnaire will be used to assess quality of life and overall health status.
Time frame: One year
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.
Time frame: One year
Contact information is provided by the study sponsor or research team.
Kasr El Aini Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
