The Effect of Omentopexy and Clips on the Staple Line During Laparoscopic Sleeve Gastrectomy on Early Postoperative Outcomes: A Randomized Trial

Study Design and Population This prospective randomized controlled trial was conducted at the University of Health Science Umraniye Training and Research hospital. The Patients who underwent LSG, were between the ages of 18 and 65, with a Body Mass Index (BMI) ≥ 40 or BMI ≥ 35 with at least one obesity-related comorbidity were included in the study. Patients who underwent other bariatric surgery procedures, who declined to be participate in the study, had uncontrolled hypertension, and had preoperative history of gastroesophageal reflux disease (GERD) symptoms were excluded. Approval for the study was received from the ethics committee of tertiary health institution (21.06.2023/218494864). This study is registered on clinicaltrial.gov (). Before the surgery, each of the participants were received comprehensive information about the study, the techniques to be applied were explained, they would be randomly assigned in one of the two groups and the consent form obtained in this context. The CONSORT reporting guidelines were used in this study (17).

Study Groups In the study, patients were divided into two groups: Patients who underwent consecutive clippping along the staple line of the remnant stomach during LSG (clips group) and patients who underwent continuous through-and-through omentopexy of the omentum to the remnant stomach staple line after resection during LSG (omentopexy group).

Data Collection Age, gender, comorbidities, smoking history, preoperative height-weight-BMI values, preoperative systolic blood pressure (SBP)-diastolic blood pressure (DBP) values, preoperative hemoglobin-hematocrit values, peroperative SBP-DBP-mean blood pressure (MBP), duration of surgery, postoperative 6th hour and time of discharge hemoglobin-hematocrit values, number of patients transfused erythrocyte suspension (ES) or requiring invasive intervention due to bleeding, length of hospital stay, hospital readmissions in the first postoperative month, and early postoperative complications were recorded. Duration of surgery was determined from the first skin incision to the last skin suture.

Preoperative, peroperative and Postoperative Evaluation Preoperative anesthesia, cardiology and pulmonology evaluations were performed for each patient. Hepatobiliary ultrasound and upper gastrointestinal endoscopy evaluation were performed. Each patient was administered low molecular weight heparin (enoxaparin 6000 units 1x1 subcutaneously) 12 hours before surgery and was taken to surgery with antiembolism stockings. Intermittant pneumatic compressor device was used perioperatively. Omentopexy was performed with 3-0 V-loc suture (26 mm, V-20 Tapper) and clippping was performed with endo clips II (10 mm, medium/large). Since ERAS protocol was applied in our clinic, no drain was placed in any patient.

At the 4th postoperative hour, all patients were mobilized, intensive respiratory exercise was performed and clear liquid food was started. Complete blood count and C-reactive protein (CRP) laboratory parameters were checked at postoperative 6th, 24th and 48th hour (discharge). Vital parameters were checked every 6 hours postoperatively. Patients who have an acute decrease in hemoglobin value together with a pulse rate of 100 or more per minute and systolic/diastolic blood pressure values below 90/60 mmHg were considered as bleeding and erythrocyte suspension was transfused. Early on the second postoperative day, the patient who could tolerate oral food and did not require additional intervention was discharged.