IRCT20190325043107N77 IRCT 2026-06-04 Tabriz University of Medical Sciences Comparison of Short-term and Long-term Outcomes of Sleeve Gastrectomy With and Without Omentoplasty Comparison of Short-term and Long-term Outcomes of Sleeve Gastrectomy With and Without Omentoplasty 2026-06-14 anticipated 98 Pending https://irct.ir/trial/90514 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study with a sample size of 98 participants, patients will be allocated into two groups using the block permutation randomization method. Each block will contain 4 participants, and all possible allocation sequences will be considered, including Block 1: BBAA, Block 2: AABB, Block 3: ABAB, Block 4: BABA, Block 5: ABBA, and Block 6: BAAB. For 98 participants, 25 blocks will be used, which will be randomly selected from numbers 1 to 6 using Random Allocation Software. For example, if block number 6 is selected as the first block and block number 2 as the second block, the resulting allocation sequence will be BAABAABB, and participants will be assigned accordingly to the intervention group (A) and the control group (B). To ensure allocation concealment, the randomization list will be prepared and numbered by an independent researcher who will not be involved in patient recruitment or assessment. The assignments will then be placed in sequentially numbered, opaque, sealed envelopes. After each patient is enrolled and assigned a study code, the investigator will open the corresponding envelope in numerical order to reveal the allocated group, thereby preventing prediction of upcoming assignments, Blinding description: In this study, to ensure the proper implementation of blinding, the interventions placed in envelopes A and B will be prepared to be completely identical in terms of shape, color, packaging, and mode of administration, so that participants will be unable to distinguish between them. Each medication will be labeled with a specific code (A or B) known only to an independent researcher, who will have no direct involvement in patient recruitment or outcome assessment. The envelopes containing the medications will be provided to the study investigator in sequential order and without any indication of the treatment identity. Accordingly, both the participants and the study investigator will remain unaware of the assigned intervention, thereby maintaining double-blind conditions throughout the study. 2-3 Condition 1: Vitamin B12. Condition 2: Body mass index. Condition 3: Nausea and vomiting. Intervention 1: Intervention group: In the omentoplasty group, the same sleeve procedure will be performed, with an additional T‑shaped omentoplasty: after excision of the gastroesophageal fat pad, the staple line will be anchored to the omentum using continuous 2/0 Ticron™ sutures up to near the angle of His. Intervention 2: Control group: In the control group, standard laparoscopic sleeve gastrectomy will be performed using a five‑trocar technique, with dissection starting 4 cm from the pylorus using LigaSure, sleeve creation over a 38‑Fr bougie with a 60‑mm stapler, and staple-line inspection with clipping if needed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.