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.

A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial.

BACKGROUND: The advantages and disadvantages of one-anastomosis gastric bypass (OAGB) with primary modified fundoplication using the excluded stomach ("FundoRing") is unclear. We aimed to assess the impact of this operation in a randomized controlled trial (RCT) and answer the next questions: (1) What the impact of wrapping the fundus of the excluded part of the stomach in OAGB on protection in the experimental group against developing de novo reflux esophagitis? (2) If preoperative RE could be improved in the experimental group? (3) Can preoperative acid reflux as measured by PH impedance, be treated by the addition of the "FundoRing"? METHODS: The study design was a single-center prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with 1-year follow-up. Endpoints were body mass index (BMI, kg/m2) and acid and bile RE assessed endoscopically by Los Angeles (LA) classification and 24-h pH impedance monitoring. Complications were graded by Clavien-Dindo classification (CDC). RESULTS: One hundred patients (n = 50 FundoRingOAGB (f-OAGB) vs n = 50 standard OAGB (s-OAGB)) with complete follow-up data were included in the study. During OAGB procedures, patients with hiatal hernia underwent cruroplasty (29/50 f-OAGB; 24/50 s-OAGB). There were no leaks, bleeding, or deaths in either group. At 1 year, BMI in the f-OAGB group was 25.3 ± 2.77 (19-30) vs 26.48 ± 2.8 (21-34) s-OAGB group (p = 0.03). In f-OAGB vs s-OAGB groups, respectively, acid RE was seen in 1 vs 12 patients (p = 0.001) and bile RE in 0 vs 4 patients (p < 0.05). CONCLUSION: Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04834635.

The Surgical Technique of Primary Modified Fundoplication Using the Excluded Stomach with Simultaneous Gastric Bypass.

PURPOSE: The aim of this work is to demonstrate a new concept of the surgical technique "FundoRing" for the prevention of acid and bile reflux esophagitis after gastric bypass. MATERIALS AND METHODS: A laparoscopic surgical technique of gastric bypass simultaneous with combined upper total and lower left partial fundoplication. This described case is a participant in an ongoing randomized clinical trial. RESULTS: The patient was without complications and was discharged on the third postoperative day. Delta BMI was 14 kg/m2 (38-24) at the 1-year follow-up. The patient did not have heartburn or bile reflux esophagitis after surgery. Evaluation of the mucosa of the esophagus by upper endoscopy after each of the 3 follow-up visits demonstrated that reflux esophagitis had resolved. Intraoperative fluorescence imaging technologies (NIR/ICG) (IMAGE1 S™ Rubina®) were to determine the quality of blood supply-no violation of the blood supply to the fundoplication wrap of the gastric pouch was detected. A CT scan clearly shows a fundoplication ring around the esophagus (two-thirds) and the upper part of the gastric pouch (one-third). CONCLUSION: The surgical technique of primary modified fundoplication using the excluded stomach with simultaneous gastric bypass is feasible.

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.

The Gastric Bypass and Fundoplication in Bariatric Surgery: the Comments on Published Papers and Our Classification of Combination Procedures.

TRIAL REGISTRATION: NCT04834635 (https://clinicaltrials.gov/ct2/show/NCT04834635).

Stapleless vs Stapled Gastric Bypass vs Hypocaloric Diet: a Three-Arm Randomized Controlled Trial of Body Mass Evolution with Secondary Outcomes for Telomere Length and Metabolic Syndrome Changes.

BACKGROUND: Obesity and metabolic syndrome (MetS) reduce life expectancy and are challenging to resolve. This randomized controlled trial (RCT) of patients with obesity and MetS undergoing surgical vs nonsurgical treatment compared changes in BMI, and secondarily, telomere length (as a biomarker of life expectancy) and changes in MetS components (insulin resistance, dyslipidemia, hypertension). METHODS: Study design was a single-center, prospective, three-arm RCT. Group 1 patients underwent novel unstapled laparoscopic one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN); Group 2, stapled laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB); and Group 3, nonsurgical weight loss therapy via a hypocaloric diet with energy restriction (HDER). The primary outcome measure was change in BMI; secondary outcome measures included change in leukocyte telomere length and other MetS components. RESULTS: Of 96 participants screened, 60 were randomly allocated to 3 groups: LOAGB-OSPAN group (n = 20), LMGB-OAGB group (n = 20), and HDER group (n = 20). At post-treatment month 12, respective BMI changes: BMI -12.13 (-8.34, -15.93); -16.04 (-11.7, 20.37); -2,76 (-3.84, -9.36) (p < 0.01). The two surgical groups experienced significant change in telomere length: LOAGB-OSPAN 2.02 (1.61, 2.41), p = 0.001; LMGB-OAGB 2.07 (1.72, 2.43), p = 0.001; and HDER 0.28 (0.22, 0.78), p = 0.26. The surgical groups were also more effective in treating MetS components. There were no deaths. Adverse events: LOAGB-OSPAN (n = 2) (Clavien-Dindo grade II); LMGB-OAGB (n = 8) (grade I (n = 6) and grade II (n = 2). CONCLUSIONS: Compared with hypocaloric diet therapy, both bariatric procedures resulted in greater BMI loss, and secondarily, a significant increase in telomere length, and greater MetS resolution. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03667469, registered on 11 September 2018.

The first modified Delphi consensus statement on sleeve gastrectomy.

INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.

Correction to: The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT).

Following publication of the original article [1], the authors notified us of a typing error in spelling Dr. Yeleuov's name. The original publication has been corrected.

Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.

BACKGROUND: One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel "staplerless" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB. METHODS: The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB. RESULTS: Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m2), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12. CONCLUSIONS: At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients. TRIAL REGISTRATION: ISRCTN56106651 (OSPAN-RCT).

Surgical technique of laparoscopic mini-gastric bypass with obstructive stapleless pouch creation: A case series.

BACKGROUND: Laparoscopic mini-gastric bypass (MGB) is a bariatric procedure which is gaining popularity worldwide. The original Rutledge technique is known to have good outcomes, but this and other surgical procedures that involve the use of staplers are very expensive for use in low-income countries. For this reason, the laparoscopic band-separated gastric bypass was developed. This paper aimed to describe a modified MGB technique without the use of staplers. METHODS: We present a modification of the MGB with the use of an obstructive stapleless pouch and anastomosis (MGB-Ospanov procedure). The technique is based on our experience in 32 patients who underwent the procedure involving this technique between January 2016 and December 2018. RESULTS: As in the original Rutledge version that uses staples, a long conduit is created below the crow's foot, extending up to the angle of His. The main differences between the MGB-Ospanov procedure and the stapler technique are as follows: creation of a gastric pouch from the anterior wall of the stomach; non-use of staplers; non-intersection of the stomach; use of semi-absorbable (or absorbable) strips of mesh; use of gastroplication to obstruct the communication between the gastric pouch and the bypassed greater part of the stomach. Gastrojejunostomy is performed using a hand-sewn suture at 150-200 cm distal from the ligament of Treitz. The body mass index (kg/m2) was 26.36 ±â€¯4.0 after surgery vs 41.6 ±â€¯6.1 before surgery (P < 0.0001). CONCLUSION: The MGB-Ospanov procedure with an obstructive stapleless pouch and hand-sewn anastomosis is more feasible and cheaper than the stapler technique. Not using staplers could potentially help in avoiding bleeding and leakage along the stapler line when creating a gastric pouch. However, further research is warranted to confirm these results.

The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT).

BACKGROUND: To date, surgeons and physicians have found positive results treating metabolic syndrome with surgical and non-surgical weight loss therapies. The purpose of this study was to evaluate changes in telomere length in patients with metabolic syndrome after weight loss. METHODS/DESIGN: This study is a three-arm randomized controlled trial. The first group is composed of patients who have undergone stapleless bypass surgery (one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN)). The second group of patients underwent standard gastric bypass surgery (laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB). The patients in the third group received non-surgical weight loss therapy, including a hypocaloric diet with energy restriction (- 500 kcal/day). The aim is to compare changes-telomere length, body mass index, comorbidities, and quality of life-in patients with metabolic syndrome after weight loss. DISCUSSION: To the best of our knowledge, this is the first randomized study to simultaneously compare the effects of surgical and non-surgical weight loss on changes in telomere length. It could provide a solution to the growing problem of metabolic syndrome. Normalization of the body mass index results in improvements in the health of patients with metabolic syndrome. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03667469 . Registered on 11 September 2018.

Gastric greater curvature plication combined with Nissen fundoplication in the treatment of gastroesophageal reflux disease and obesity.

BACKGROUND AND AIM: Established anti-reflux procedures such as fundoplications are less efficient in obese patients. The aim of this study was to investigate clinical effectiveness of the fundoplication combined with gastric greater curvature plication in the treatment of gastroesophageal reflux disease (GERD) in obese patients. MATERIALS AND METHODS: During the period from June 2010 to September 2014, patients operated for GERD with BMI from 30 to 39.9kg/m2 were included into the prospective study. Laparoscopic Nissen fundoplication (LNF, n=58) was performed until February 2013 and later laparoscopic Nissen fundoplication was combined with gastric greater curvature plication (LNFGP, n=56). The groups were compared according to the control of GERD and weight loss. RESULTS: In LNF group there were significantly more males, patients had lower BMI and longer duration of GERD symptoms. Duration of surgery was significantly longer in LNFGP group, 96.5 (17.3)min vs. 59.8 (16.1)min (P<0.0001). Postoperative morbidity was similar, 3.6% and 3.4% in LNFGP and LNF groups, respectively (P=0.9539). The average percentage of excess BMI loss after 12 months was 45.3 (5.8) in LNFGP group as compared to 18.4 (4.6) in LNF group (P<0.0001). Significantly more patients experienced remission or improvement of type 2 diabetes mellitus (P=0.03) and hypercholesterolemia (P=0.0001) in LNFGP group. No significant differences between the groups in postoperative DeMeester score, GERD-HRQL mean score, overall satisfaction and healing of esophagitis were observed. CONCLUSIONS: LNFGP took significantly longer time to perform, but resulted in significantly higher weight reduction and remission/improvement of comorbidities. Both procedures produced similar anti-reflux effect.

Laparoscopic Band-Separated One Anastomosis Gastric Bypass.

BACKGROUND: This video demonstrates laparoscopic band-separated one anastomosis gastric bypass-combining the advantages of banding and gastric bypass without stapler and cutter use. This is basically a gastrojejunal loop bypass above an obstructive band in the upper stomach. MATERIALS AND SURGICAL TECHNIQUE: An adjustable low pressure "Medsil" gastric band was introduced in the abdomen and retracted through the retrogastric tunnel. The front wall of the stomach below the band was displaced in the upward direction through the ring band, increasing the size of the anterior portion of the stomach pouch so that a gastroenteroanastomosis could be created at this point. Gastro-gastric sutures were placed to create a gastro-gastric plication around the band and hold it in position. The band tubing was exteriorized and connected to a special port, which was secured to the abdominal wall fascia. A jejunal loop was created about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch by hand using Vicryl 2/0 sutures. RESULTS: Between November 2015 and February 2016, the study was performed on 10 patients. The average operating time for all cases was 75 min (range 63-87). There was no morbidity or mortality. No complications were observed, including band erosion and band infection. Operation costs were about $2000 lower with this method than with standard gastric bypass surgery. Postop the patients lost weight by 3-4 kg per month. CONCLUSION: Preliminary results show that laparoscopic band-separated one anastomosis gastric bypass have feasibility, safety, efficacy, and reduced operating costs.