[A prospective randomized controlled trial of the effect of sleeve gastrectomy combined with His angle reconstruction on postoperative gastroesophageal reflux after surgery].

Objective

To compare the incidence of gastroesophageal reflux disease (GERD) following sleeve gastrectomy (SG) alone versus SG with reestablishment of the acute angle of His (SG-His), and to evaluate the safety and clinical efficacy of the latter approach.

Methods

A total of 124 obese patients admitted to Beijing Chaoyang Hospital, Capital Medical University from January 2023 to December 2023 were enrolled in this randomized controlled study and assigned to either the study group (SG-His, n=64) or the control group (SG, n=60). Surgical duration, postoperative complications and postoperative pain were recorded. Reflux symptoms were assessed using the Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GerdQ) scores preoperatively and at 1, 3, 6, and 12 months postoperatively. Weight loss outcomes were evaluated at 12 months post-surgery.

Results

Twelve months Follow-up was completed by 56 patients in the SG-His group and 55 in the SG group, yielding a dropout rate of 10.5%. No significant differences were observed between groups in baseline characteristics, including reflux scores, body weight, BMI, and comorbidities (all P>0.05). Operative time, postoperative complication rates, and pain-related metrics were comparable between groups (all P>0.05). With regard to reflux outcomes in the per protocol set, the SG-His group exhibited significantly lower RDQ scores than the SG group at 1 month [1.0 (0.0-7.0) vs. 5.0 (1.0-9.0), P=0.015], 3 months [0.0 (0.0-4.0) vs. 6.0 (0.5-9.0), P<0.001], 6 months [0.0 (0.0-2.0) vs. 4.0 (0.0-9.0), P<0.001], and 12 months [0.0 (0.0-4.0) vs. 2.0 (0.0-7.0), P=0.020] postoperatively. In the per protocol set, the GerdQ score was also significantly lower in the SG-His group at 6 months [6.0 (6.0-6.8) vs. 6.0 (6.0-8.0), P=0.014], although no significant differences were found at 1, 3, or 12 months (all P>0.05). According to RDQ criteria, the proportion of patients diagnosed with GERD was significantly lower in the SG-His group at 1 month [8.2% (5/61) vs. 21.1% (12/57), P=0.047], 3 months [3.5% (2/57) vs. 19.6% (11/56), P=0.007], 6 months [1.8% (1/56) vs. 17.9% (10/56), P=0.004], and 12 months [1.8% (1/56) vs. 14.5% (8/55), P=0.034]. Similarly, based on GerdQ criteria, GERD diagnosis rates were significantly reduced in the SG-His group at 3 months [21.1% (12/57) vs. 41.1% (23/56), P=0.021], 6 months [10.7% (6/56) vs. 30.4% (17/56), P=0.010], and 12 months [14.3% (8/56) vs. 36.4% (20/55), P=0.007]. There were no significant differences in weight loss between the two groups at 12 months post-surgery (P>0.05).

Conclusions

Sleeve gastrectomy with reestablishment of the acute angle of His significantly reduces the incidence and severity of postoperative gastroesophageal reflux, effectively mitigates GERD symptoms, and maintains equivalent weight loss outcomes compared to SG alone. This technique is a safe and effective surgical technique.