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.

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. 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.

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.

PONV, vitamin D, iron, zinc, fasting blood sugar.

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.