Clinical trial

Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass

Recruiting now · Not applicable · 1 countries · Registry ID NCT07461610

Recruiting nowNot applicableObservational

What this study is about

The goal of this observational study is to learn whether routine stool tests can detect changes in gut function 6 months after two common types of weight loss surgery: sleeve gastrectomy and gastric bypass (including mini gastric bypass and Roux-en-Y gastric bypass). The main questions it aims to answer are: Do stool tests show more signs of undigested food or carbohydrate malabsorption after gastric bypass compared to sleeve gastrectomy? Do signs of gut inflammation in stool (like fecal calprotectin) decrease after surgery, and does this relate to improvements in blood sugar and weight loss? Can simple stool test results at 6 months predict how much weight a person loses or how well their diabetes improves? Researchers will compare stool test results between the two surgery groups (sleeve gastrectomy vs. gastric bypass) to see if the type of surgery leads to different changes in gut health. Participants will: Provide a stool sample before surgery and again 6 months after surgery Provide a blood sample at the same time points to measure weight, blood sugar, and cholesterol Undergo their planned weight loss surgery as part of their regular medical care

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionMorbid Obesity

Full registry criteria

Inclusion Criteria: * Male and female patients aged 18 to 60 years * Body Mass Index (BMI) ≥ 40 kg/m², OR BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (type 2 diabetes, hypertension, dyslipidemia, osteoarthritis, obstructive sleep apnea) * Patients scheduled for primary laparoscopic bariatric surgery (either SG or Gastric Bypass \[MGB or RYGB\]) at Kasr Al-Ainy University Hospitals * Provision of written informed consent Exclusion Criteria: * Age \< 18 years or \> 60 years * Previous bariatric surgery or major gastrointestinal surgery (gastric, intestinal, or colorectal resection) * Chronic kidney disease (eGFR \< 60 mL/min/1.73m²) or previous renal transplant * Chronic liver disease (cirrhosis, chronic hepatitis) or liver failure * Chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, or chronic pancreatitis * Active malignancy or history of chemotherapy/radiotherapy in the past 5 years * Pregnancy or breastfeeding * Chronic alcohol abuse or substance abuse * Use of antibiotics, probiotics, or prebiotics within 4 weeks prior to stool sample collection (to avoid confounding effects on gut flora) * Acute gastrointestinal infection at the time of sample collection

Treatments and study arms

Laparoscopic Sleeve Gastrectomy

Procedure

Laparoscopic sleeve gastrectomy performed using a standard technique with a 36-Fr bougie, transecting the stomach starting 4-6 cm from the pylorus, excising the entire greater curvature and fundus. The staple line is inspected for hemostasis and leakage.

Mini Gastric Bypass

Procedure

Laparoscopic mini gastric bypass performed using a standard technique with a long gastric tube created from the angle of His to the antrum, and a loop gastrojejunostomy with a biliopancreatic limb of 200 cm.

Roux-en-Y Gastric Bypass

Procedure

Laparoscopic Roux-en-Y gastric bypass performed using a standard antecolic, antegastric technique. A small 30-mL gastric pouch is created. The biliopancreatic limb is 70-150 cm, and the alimentary (Roux) limb is 100-150 cm. Jejunojejunostomy is performed to restore continuity.

Primary outcomes

Change in Stool pHAt Baseline and at 6 months postoperatively

Change in stool pH measured by pH indicator strip from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Change in Fecal Calprotectin LevelAt Baseline and at 6 months postoperatively

Change in fecal calprotectin concentration (μg/g) measured by ELISA from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Presence of Undigested Food ParticlesAt Baseline and at 6 months postoperatively

Presence or absence of undigested meat fibers and vegetable particles on microscopic examination at 6 months after surgery. Comparison of prevalence between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Presence of Reducing SubstancesAt Baseline and at 6 months postoperatively

Presence or absence of reducing substances (indicating carbohydrate malabsorption) measured by Clinitest tablets at 6 months after surgery. Comparison of prevalence between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Change in Stool White Blood Cell CountAt Baseline and at 6 months postoperatively

Change in white blood cell count (cells per high-power field) on microscopic examination from preoperative baseline to 6 months after surgery. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Change in Stool Red Blood Cell CountAt Baseline and at 6 months postoperatively

Change in red blood cell count (cells per high-power field) on microscopic examination from preoperative baseline to 6 months after surgery. Presence of RBCs may indicate mucosal irritation at staple lines or altered barrier function. Comparison will be made between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Medicine Cairo University🇪🇬 Cairo, Al-Manial Cairo, Egypt

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Mahmoud El Azhary, LecturerContact

Email · Call +201064110221