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Optimizing Intraoperative Systolic Blood Pressure for Bleeding Control in Bariatric Surgery

Optimizing Intraoperative Systolic Blood Pressure for Bleeding Control in Bariatric Surgery: A Randomized Trial with Staple-Line Reinforcement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603858166142
Enrollment
300
Registered
2026-03-24
Start date
2022-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine Surgery Anaesthesia

Interventions

Protocolized Intraoperative Hemodynamic Management SBP Target 130 mmHg
Protocolized Intraoperative Hemodynamic Management SBP Target 150 mmHg
Protocolized Intraoperative Hemodynamic Management SBP Target 170 mmHg

Sponsors

Faculty of Medicine Ain Shams University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 18–60 years Body mass index (BMI) =40 kg/m² BMI =35 kg/m² with at least one obesity-related comorbidity (type 2 diabetes mellitus, hypertension, or obstructive sleep apnea) Scheduled for primary laparoscopic bariatric surgery (LSG, RYGB, or OAGB) with planned staple line reinforcement via omentopexy Provided written informed consent

Exclusion criteria

Exclusion criteria: Previous upper gastrointestinal or bariatric surgery Revision bariatric procedures Severe cardiovascular instability or uncontrolled hypertension Chronic liver failure or renal failure Coagulopathy or ongoing anticoagulation that could not be safely discontinued Pregnancy Refusal to participate.

Design outcomes

Primary

MeasureTime frame
Postoperative bleeding defined hierarchically as: (1) Clinical bleeding (hematemesis/melena or need for endoscopic/surgical hemostasis); (2) Hemoglobin drop =2.5 g/dL within 72 hours not attributable to hemodilution; including radiologically confirmed intra-abdominal bleeding.

Secondary

MeasureTime frame
Rate of blood transfusion;Reoperation for bleeding;30-day cardiovascular complications (arrhythmia requiring intervention, myocardial infarction confirmed by biomarkers and ECG changes, or ischemic stroke confirmed radiologically) ;Length of hospital stay;Anastomotic or staple line leakage;Stricture rate;Infection Rate

Countries

Egypt

Contacts

Public ContactGamal Abdalla

Lecturer of General Surgery Faculty of Medicine Ain Shams University

GamalAbdalla@med.asu.edu.eg00201065754272

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 10, 2026