A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease.

Background and Objectives: Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. The purpose of this study is to compare bariatric and antireflux results after OAGB with different methods of fundoplication using the excluded stomach and without fundoplication. Materials and methods: This open-label, randomized, parallel three-arm trial was conducted from March 2019 and December 2021. All patients underwent laparoscopic one-anastomosis gastric bypass and suture cruroplasty, and then had a follow-up at 24 months. Group 1 of patients had fundoplication FundoRing using the excluded stomach (FundoRingOAGB); Group 2, with Nissen fundoplication using the excluded stomach (NissenOAGB); and Group 3, without fundoplication (OAGB). We studied changes in BMI, GERD symptoms (GERD-HRQL), and the VISICK score. Results: Of 219 participants screened, 150 were randomly allocated to 3 groups: FundoRingOAGB group (n = 50), NissenOAGB group (n = 50), and OAGB group (n = 50). At post-treatment month 24, BMI changes were as follows: from 40.7 ± 5.9 (31-53) to 24.3 ± 2.8 (19-29) kg/m2 in FundoRingOAGB group; from 39.9 ± 5.3 (32-54) to 26.3 ± 2.9 (23-32) kg/m2 in Nissen group; and from 40.9 ± 6.2 (32-56) to 28.5 ± 3.9 (25-34) kg/m2 in OAGB group. The mean pre-operative GERD-HRQL heartburn score improved post-op in FundoRingOAGB group from 20.6 ± 2.24 (19.96, 21.23) to 0.44 ± 0.73 (0.23, 0,64); in NissenOAGB group from 21.34 ± 2.43 (20.64, 22.03) to 1.14 ± 1.4 (0.74, 1.53); and in OAGB group 20.5 ± 2.17 (19.9, 21.25) to 2.12 ± 1.36 (1.73, 2.5). GERD-HRQL total scores were from pre-op 25.2 ± 2.7 (24.4, 25.9) to 4.34 ± 1.3 (3.96, 4.7) post-op in FundoRingOAGB group; 24.8 ± 2.93 (24, 25.67) pre-op to 5.42 ± 1.7 (4.9, 5.9) in the NissenOAGB group; and from 21.46 ± 2.7 (20.7, 22.2) to 7.44 ± 2.7 (6.6, 8.2) in the OAGB group. The mean VISICK score improved from 3.64 ± 0.94 (3.7, 3.9) to 1.48 ± 1.26 (1.12, 1.84) in FundoRingOAGB, from 3.42 ± 0.97 (3.1, 3,7) to 2.5 ± 1.46 (2.06, 2.9) in NissenOAGB group and from 3.38 ± 0.88 (3.1, 3,69) to 2.96 ± 1.19 (2.62, 3.2) in OAGB group. Conclusions: Antireflux and bariatric results of FundoRingOAGB are better than using the NissenOAGB method and significantly better than OAGB without the use of fundoplication.

The surgical management of penile oleogranuloma: case series.

Oleogranuloma of the penis is a complex set of pathological processes caused by the injection of a foreign substance (gel, balls, rods, etc.) into the penis with the purpose of penile augmentation. In this case series, we investigated a variety of clinical presentations of oleogranuloma and described our experience in managing the complications. We analyzed data on 18 patients with penile self-injections admitted to the hospitals of Astana City, Kazakhstan, during an 11-year period. The mean age of patients at admittance was 37.4 ± 6.4 years. The most common substance of injection was Vaseline (n = 16, 88.9%). The mean interval between the time of injection and the first presentation to the hospital was 10.8 ± 6.5 years. Complications included necrosis (n = 13, 72.2%), pain or swelling (n = 6, 33.3%) and cosmetic dissatisfaction (n = 5, 27.8%). All patients received surgical treatment (n = 18, 100%): simple excision with primary closure was performed for one-half of the patients (n = 9, 50%), while another half of patients underwent the two-stage scrotum skin flap surgery (n = 9, 50%). The findings of this study should raise the awareness about the diverse clinical presentations of penile self-injections among physicians for early diagnosis and timely management.

A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic one anastomosis gastric bypass (LOAGB) is a simple variation of gastric bypass and has gained worldwide popularity with clinical outcomes similar to laparoscopic Roux-en-Y gastric bypass (LRYGB) for weight loss and management of comorbidities. However, biliary reflux to the esophagus negates the benefits of LOAGB. In addition, weight gain after LOAGB and after LRYGB is a major problem in bariatric surgery. The aim of this article is to describe the design and protocol of a randomized controlled trial comparing the outcomes of two methods of LOAGB: experimental method with wrapping versus standard method nonwrapping fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB. METHODS: The study was designed as a single-center prospective, interventional, randomized controlled trial. Masking: None (open label). Allocation: randomized. Enrollment: 100 obese patients. The relevant ethics committee approved the trial protocol. The endpoints (body mass index, bile reflux in the esophagus, other reflux symptoms) will be assessed presurgery and postsurgery (12, 24, and 36 months postoperatively). DISCUSSION: With its 3-year follow-up time, this RCT will provide important data on the impact of wrapping the fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB. TRIAL REGISTRATION: ClinicalTrials.gov NCT04834635 . Registered on 8 April 2021.