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

This study is a randomized, double-blind, parallel-group clinical trial with two arms (sleeve gastrectomy with omentoplasty vs without omentoplasty), conducted as a phase 2–3 trial in 98 patients. Randomization will be performed using permuted block randomization with a block size of four.

Both groups undergo standard 5-trocar laparoscopic sleeve gastrectomy (starting 4 cm from the pylorus over a 38-Fr bougie). In the omentoplasty group, a T-shaped omentoplasty is additionally performed by anchoring the staple line to the omentum using continuous 2/0 Ticron™ sutures up to near the angle of His.

Eligible participants were patients with obesity undergoing laparoscopic sleeve gastrectomy at Sina Hospital who provided written informed consent. Exclusion criteria included secondary obesity due to endocrine disorders, prior bariatric surgery, severe systemic disease or active malignancy, pregnancy or lactation, withdrawal of consent, or incomplete postoperative follow-up.

In this study, which will be conducted at Imam Reza Hospital, Tabriz, patients who are candidates for sleeve gastrectomy will be divided into two groups: Group A, in which patients will undergo omentoplasty in addition to sleeve gastrectomy, and Group B, in which patients will undergo sleeve gastrectomy alone. This procedure will be performed by the specialist surgeon based on their clinical judgment.

The severity and incidence of postoperative nausea and vomiting (PONV), vitamin D, iron, zinc, fasting blood glucose, and all micronutrients (some micronutrients may be present in the original manuscript file but are currently not available here).

The relevant variables have been added.

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.

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.