Digestive System Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (=18 years) scheduled for primary laparoscopic sleeve gastrectomy Presence of small-to-moderate sliding hiatal hernia (=5 cm axial displacement) confirmed preoperatively Mild gastroesophageal reflux disease (GERD) defined as symptoms controlled or partially controlled with intermittent or once-daily proton pump inhibitor therapy Los Angeles grade A esophagitis or no esophagitis on preoperative endoscopy Hernia anatomy deemed suitable for tension-free posterior cruroplasty Provision of written informed consent
Exclusion criteria
Exclusion criteria: Moderate-to-severe esophagitis (Los Angeles grades B–D) Barrett’s esophagus Reflux-related strictures Severe bile reflux gastritis Suspected or documented esophageal motility disorders Clinical indication favoring Roux-en-Y gastric bypass Large (>5 cm) or paraesophageal hiatal hernia Anticipated need for mesh reinforcement Previous foregut or bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite functional adverse outcome at 12 months defined as any of the following: (1) Radiologically confirmed hiatal hernia recurrence or intrathoracic sleeve migration; (2) Clinically significant GERD requiring continuous daily proton pump inhibitor therapy or endoscopic esophagitis in symptomatic patients; (3) Symptomatic functional sleeve stenosis or torsion confirmed by imaging or endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative duration;Intraoperative blood loss;Early postoperative nausea and vomiting;Early dysphagia;Length of hospital stay;GERD-HRQL score;Daily PPI use;Radiologic sleeve position;Endoscopic intervention; Readmission;Revisional surgery | — |
Countries
Egypt
Contacts
Lecturer of General Surgery Faculty of Medicine Ain Shams University