Health TrialsbyHealthPanel

Stool Analysis After Sleeve Gastrectomy vs Gastric Bypass

ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with morbid obesity scheduled for primary bariatric surgery at Kasr Al-Ainy University Hospitals, Cairo, Egypt.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Laparoscopic Sleeve Gastrectomy

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Sleeve Gastrectomy (SG)1 intervention
Group B: Gastric Bypass (MGB/RYGB)2 interventions

Trial outcomes

Primary outcomes

1

Change in Stool pH

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.

Time frame
At Baseline and at 6 months postoperatively
2

Change in Fecal Calprotectin Level

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.

Time frame
At Baseline and at 6 months postoperatively
3

Presence of Undigested Food Particles

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.

Time frame
At Baseline and at 6 months postoperatively
4

Presence of Reducing Substances

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.

Time frame
At Baseline and at 6 months postoperatively

Secondary outcomes

1

Percentage Total Weight Loss (%TWL)

Percentage total weight loss calculated as \[(initial weight - 6-month weight) / initial weight\] × 100. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Time frame
6 months postoperatively
2

Diabetes Remission Rate

Proportion of patients with type 2 diabetes at baseline who achieve remission, defined as HbA1c \< 6.5% off all antidiabetic medications at 6 months postoperatively. Comparison between Sleeve Gastrectomy (SG) and Gastric Bypass (MGB/RYGB) groups.

Time frame
6 months postoperatively
3

Change in Fasting Plasma Glucose

Change in fasting plasma glucose (mg/dL) from preoperative baseline to 6 months after surgery

Time frame
At Baseline and at 6 months postoperatively
4

Change in HbA1c

Change in glycated hemoglobin (HbA1c %) from preoperative baseline to 6 months after surgery.

Time frame
At Baseline and at 6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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