Magnetic compression anastomosis gastrojejunostomy: feasibility and efficacy of a novel device in a swine model.

BACKGROUND: Means of addressing technical challenges in forming gastrojejunostomy (GJ) anastomoses and maintaining their patency are sought. OBJECTIVES: Evaluation of preclinical feasibility and healing efficacy of a novel linear magnetic compression anastomosis (MCA) device to form a patent GJ versus sutured jejunal enterotomy (JE) sites in swine. SETTING: Single-center veterinary testing facility. METHODS: Feasibility of 3 prototype sizes (4, 6, and 8 cm) of a metal MCA device (MCAD) to form a patent GJ was evaluated over 6 weeks. A distal magnet was laparoscopically inserted in the jejunum, a proximal magnet was placed gastroscopically in the stomach; magnets were aligned to gradually form an anastomosis, self-detached, and be expelled. At necropsy, MCAs were assessed for patency and compared with JE tissues to evaluate wound healing. RESULTS: MCADs aligned at the GJ location without complications. In 5/6 MCAD pairs, dislodgement occurred between 7 and 26 days; expulsion 13-31 days; 1 MCAD pair was retained in the stomach. At necropsy, all pigs were healthy, gaining a mean 15.0 kg. Anastomoses were not adequately patent in 2/4 pigs receiving the 4-cm or 6-cm MCADs because their linear length was too small. But, anastomoses of both pigs receiving the 8-cm MCADs maintained full patency. Minimal inflammation and fibrosis were seen in MCA specimens versus sutured enterotomies. CONCLUSIONS: A novel linear MCA device was feasible and effectively created a patent GJ anastomosis in swine with minimal inflammation and fibrosis. The MCAD may be appropriate for clinical evaluation.

Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy.

BACKGROUND: Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs). OBJECTIVES: The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]). SETTING: Multicenter: private practices and university hospitals. METHODS: In patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved. CONCLUSIONS: In early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.

Standardization of the One-anastomosis Gastric Bypass Procedure for Morbid Obesity: Technical Aspects and Early Outcomes.

BACKGROUND: One-anastomosis gastric bypass (OAGB) has become an accepted metabolic/bariatric surgery procedure. This study aimed to describe our center's standardized OAGB operative technique and report early (≤30 d) safety outcomes in patients with severe obesity. METHODS: The medical records of patients who had undergone either primary (n=681, 88.0%) or revisional OAGB (n=93, 12.0%) were retrospectively evaluated. Patient demographics, operative time, length of hospital stay, readmissions, reoperations, and ≤30-day morbidity and mortality rates were analyzed. RESULTS: A total of 774 consecutive patients with severe obesity (647 female, 83.6%) underwent OAGB between January 2016 and December 2021. Their mean age was 36.2±10.8 years (range: 18 to 70 y) and mean body mass index was 42.7±4.2 kg/m 2 (range: 17.2 to 61 kg/m 2 ). Mean operating time was 52.6±19.9 minutes (range: 25 to 295 min) and length of hospital stay was 1.6±0.9 days (range: 1 to 9 d). Early postoperative complications occurred in 16 cases (2.1%), including 2 leaks with an intra-abdominal abscess (0.3%), bleeding (n=3, 0.4%), acute kidney failure (n=1, 0.15%), urinary tract infection (n=2, 0.3%), and intensive care unit stay (n=4, 0.5%). Seventy patients (9.1%) were readmitted, and re-laparoscopy was performed in 1 patient (0.1%). There was no mortality. CONCLUSIONS: In the very early term, OAGB was a safe primary and revisional metabolic/bariatric surgery operation. Consistent performance of a standardized OAGB procedure contributed to low rates of morbidity and mortality in the hands of metabolic/bariatric surgeons with good laparoscopic skills at a high-volume center.

Long-Term Matched Comparison of Primary and Revisional Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Reports of long-term (> 5-15-year) outcomes assessing the safety and efficacy of primary revisional laparoscopic sleeve gastrectomy (LSG) are few. METHODS: Retrospective long-term comparisons of primary (pLSG) and revisional (rLSG) procedures were matched for gender, age ± 5 years, and body mass index (BMI) ± 5 kg/m2. Weight loss, associated medical condition status, and patient satisfaction were evaluated. RESULTS: Between May 1, 2006, and December 31, 2016, 194 matched patients with severe obesity (mean BMI 44.1 ± 6.7 kg/m2; age 44.2 ± 10.0 years, 67.0% female) underwent pLSG (n = 97) or rLSG (n = 97) and were followed for a mean 12.1 ± 1.5 vs 7.6 ± 2.1 years. Respective mean weight regain from nadir was 15.0 ± 14.4 kg vs 11.9 ± 12.2 kg. Respective percent mean total weight loss and excess weight loss were 20.9 ± 12.7% and 51.8 ± 33.1%, and 18.3 ± 12.8% and 43.4 ± 31.6% at last follow-up, with no significant difference between groups. Resolution of type 2 diabetes (HbA1C < 6.5%, off medications) was 23.1% vs 11.1%; hypertension 36.0% vs 16.0%; and hyperlipidemia 37.1% vs 35.3%. Patients in the pLSG group were significantly more satisfied with LSG (59.8% vs 43.3%, p < 0.05) and more likely to choose the procedure again. CONCLUSIONS: There were no significant differences in long-term weight loss or associated medical condition outcomes in matched pLSG and rLSG patients.

Endoscopic Kehr's T-Tube Placement to Treat Persistent Large Gastro-cutaneous Fistula After One Anastomosis Gastric Bypass: Video Demonstration.

BACKGROUND: We aim to show the endoscopic placement of a T-tube to treat a persistent large gastro-cutaneous fistula after OAGB. METHODS: We present the case of a 46-year-old woman with BMI of 48 kg/m2, who underwent OAGB and was re-operated on the 2nd postoperative day (POD) for leakage. Washing and drainage of the abdominal cavity was performed, and no fistulous orifice was identified. An upper gastrointestinal (GI) endoscopy was performed at POD 20 for the persistence of leakage of 150 ml/day by the drain and a gastric fistulous orifice of 2 cm was detected. RESULTS: At POD 22, under general anesthesia, upper GI endoscopy was performed and a T-tube was placed in the fistulous orifice with a "rendez-vous" technique (as demonstrated in the Video), placing the T branch in the digestive lumen pressed against the wall and the long part of the T exiting at the cutaneous orifice. The T-tube was clamped after 3 days and the patient could be gradually re-fed. The patient was discharged 8 days after the procedure, with perfect clinical tolerance and no complications. The ablation of the tube one was performed on POD 84. No relapse occurred during a follow-up of 48 months. CONCLUSION: Persistent large gastro-cutaneous fistulas with an orifice bigger than 1 cm in diameter are difficult to manage. The endoscopic placement of a T-tube seems a useful option, which may facilitate the healing of the fistula. Further studies are needed to better define the role of this procedure.

Treatment of Persistent Large Gastrocutaneous Fistulas After Bariatric Surgery: Preliminary Experience with Endoscopic Kehr's T-Tube Placement.

PURPOSE: Post-bariatric surgery gastrocutaneous fistula is a chronic leak with an incidence of 1.7 to 4.0% and no standardized management. A large gastrocutaneous fistula (LGCF) is not indicated for treatment with pigtail drains. We aimed to evaluate results of a novel treatment using endoscopic Kehr's T-tube placement. METHODS: Only patients with a postoperative LGCF duration of > 10 days and a flow rate of > 50 cc by external drainage after revisional surgery for sepsis were included. Endoscopic placement of Kehr's T-tube was performed. Patients had been reoperated with wash and drainage for severe sepsis after initial bariatric surgery in which no fistula had been discovered. Patients not reoperated, or with a fistula requiring intraoperative Kehr's T-tube placement, or a pigtail drain were excluded. Primary outcomes were endoscopic characteristics and results (LGCF closure rate, Kehr T-tube retention time, etc.). RESULTS: The study group included 12 women, 2 men; body mass index 43.1 ± 4.5 kg/m2. Interventions were SG (7), RYGB (2), OAGB (4), and SADI-S (1). Endoscopic assessment was carried out after a mean of 33.2 ± 44.3 days after the bariatric procedure. The mean fistula orifice diameter was 2.0 ± 0.9 cm. Kehr's T-tube was positioned at a mean 51.5 ± 54.8 days after the bariatric procedure. T-tube tolerance was excellent. Mean additional days: hospitalization, 34.4 ± 27.0; T-tube retention, 86.4 ± 73.1; fistula healing, 139.9 ± 111.5, LGCF closure rate, 92.9%. COMPLICATIONS: 1 pulmonary embolism, 2 T-tube migrations,1 drain-path bleed, 1 skin abscess. No mortality. CONCLUSIONS: Endoscopic Kehr's T-tube placement was successful in closing persistent post-bariatric surgery LGCF in 92.9% of patients.

Serum Glucagon, Bile Acids, and FGF-19: Metabolic Behavior Patterns After Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.

BACKGROUND: Metabolic/bariatric surgery is a highly effective treatment for obesity and metabolic diseases. Serum glucagon, bile acids, and FGF-19 are key effectors of various metabolic processes and may play central roles in bariatric surgical outcomes. It is unclear whether these factors behave similarly after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). METHODS: Serum glucagon, bile acids (cholic acid [CA], chenodeoxycholic acid [CDCA], deoxycholic acid [DCA]), and FGF-19 were analyzed in samples of fasting blood collected before bariatric surgery, on postoperative days 2 and 10, and at 3- and 6-month follow-up. RESULTS: From September 2016 to July 2017, patients with obesity underwent RYGB or VSG; 42 patients (RYGB n = 21; VSG n = 21) were included in the analysis. In the RYGB group, glucagon, CA, and CDCA increased continuously after surgery (p = 0.0003, p = 0.0009, p = 0.0001, respectively); after an initial decrease (p = 0.04), DCA increased significantly (p = 0.0386). Serum FGF-19 was unchanged. In the VSG group, glucagon increased on day 2 (p = 0.0080), but decreased over the 6-month study course (p = 0.0025). Primary BAs (CA and CDCA) decreased immediately after surgery (p = 0.0016, p = 0.0091) and then rose (p = 0.0350, p = 0.0350); DCA followed the curve of the primary BAs until it fell off at 6 months (p = 0.0005). VSG group serum FGF-19 trended upward. CONCLUSION: RYGB and VSG involve different surgical techniques and final anatomical configurations. Between postoperative day 2 and 6-month follow-up, RYGB and VSG resulted in divergent patterns of change in serum glucagon, bile acids, and FGF-19.

Standardization of Bariatric Metabolic Procedures: World Consensus Meeting Statement.

BACKGROUND: Standardization of the key measurements of a procedure's finished anatomic configuration strengthens surgical practice, research, and patient outcomes. A consensus meeting was organized to define standard versions of 25 bariatric metabolic procedures. METHODS: A panel of experts in bariatric metabolic surgery from multiple continents was invited to present technique descriptions and outcomes for 4 classic, or conventional, and 21 variant and emerging procedures. Expert panel and audience discussion was followed by electronic voting on proposed standard dimensions and volumes for each procedure's key anatomic alterations. Consensus was defined as ≥ 70% agreement. RESULTS: The Bariatric Metabolic Surgery Standardization World Consensus Meeting (BMSS-WOCOM) was convened March 22-24, 2018, in New Delhi, India. Discussion confirmed heterogeneity in procedure measurements in the literature. A set of anatomic measurements to serve as the standard version of each procedure was proposed. After two voting rounds, 22/25 (88.0%) configurations posed for consideration as procedure standards achieved voting consensus by the expert panel, 1 did not attain consensus, and 2 were not voted on. All configurations were voted on by ≥ 50% of 50 expert panelists. The Consensus Statement was developed from scientific evidence collated from presenters' slides and a separate literature review, meeting video, and transcripts. Review and input was provided by consensus panel members. CONCLUSIONS: Standard versions of the finished anatomic configurations of 22 surgical procedures were established by expert consensus. The BMSS process was undertaken as a first step in developing evidence-based standard bariatric metabolic surgical procedures with the aim of improving consistency in surgery, data collection, comparison of procedures, and outcome reporting.

Metabolic (Bariatric and Nonbariatric) Surgery for Type 2 Diabetes: A Personal Perspective Review.

: Metabolic surgery can cause amelioration, resolution, and possible cure of type 2 diabetes. Bariatric surgery is metabolic surgery. In the future, there will be metabolic surgery operations to treat type 2 diabetes that are not focused on weight loss. These procedures will rely on neurohormonal modulation related to the gut as well as outside the peritoneal cavity. Metabolic procedures are and will always be in flux as surgeons seek the safest and most effective operative modality; there is no enduring gold standard operation. Metabolic bariatric surgery for type 2 diabetes is more than part of the clinical armamentarium, it is an invitation to perform basic research and to achieve fundamental scientific knowledge.

Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review.

OBJECTIVE: The study compared laparoscopic sleeve gastrectomy (LSG) staple-line leak rates of 4 prevalent surgical options: no reinforcement, oversewing, nonabsorbable bovine pericardial strips (BPS), and absorbable polymer membrane (APM). BACKGROUND: LSG is a multipurpose bariatric/metabolic procedure with effectiveness proven through the intermediate term. Staple-line leak is a severe complication of LSG for which no definitive method of prevention has been identified. METHODS: The systematic review study design was employed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement screening guidelines. Inclusion criteria centered on variables potentially relevant to LSG leak: leak rate, age, gender, calibrating bougie size, distance between pylorus and gastric transection line, overall complication rate, and mortality. Analysis of variance models were used to explore differences in select demographic and surgical technique variables characterizing each reinforcement group. An omnibus χ(2) test followed by independent Fisher's exact tests were used to compare leak rates. RESULTS: There were 659 articles identified; 41 duplicates removed. Of 618 remaining articles, 324 did not meet inclusion criteria. Of the 294 remaining articles, 206 were eliminated (kin studies, those not reporting staple-line or leak incidence, those reporting discontinued products). There were 88 papers included in the analysis. Statistically significant differences were found between groups across demographic and surgical variables studied (p<0.001). There were 191 leaks in 8,920 patients; overall leak rate 2.1%. Leak rates ranged from 1.09% (APM) to 3.3% (BPS); APM leak rate was significantly lower than other groups (p< 0.05). CONCLUSION: Systematic review of 88 included studies representing 8,920 patients found that the leak rate in LSG was significantly lower using APM staple-line reinforcement than oversewing, BPS reinforcement, or no reinforcement.

Laparoscopic reinforced sleeve gastrectomy: early results and complications.

BACKGROUND: Sleeve gastrectomy (SG) was pioneered as a two-stage intervention for super and super-super obesity to minimize morbidity and mortality; it is employed increasingly as a primary procedure. Early outcomes and integrity of laparoscopic SG (LSG) against leak using a technique incorporating gastric transection-line reinforcement were studied. METHODS: Between 2003 and 2009, 121 patients underwent LSG (16, two-stage; 105, primary). Of the patients, 66% were women, mean age 38.8 ± 10.9 (15.0-64.0), and body mass index (BMI, kg/m(2)) 48.7 ± 9.3 (33.7-74.8). Bovine pericardium (Peri-Strips Dry [PSD]) was used to reinforce the staple line. Parametric and nonparametric tests were used, as appropriate. The paired t test was used to assess change from baseline; bivariate analyses and logistic regression were used to identify preoperative patient characteristics predictive of suboptimal weight loss. RESULTS: Mean operative time was 105 min (95-180), and mean hospitalization was 5.6 days (1-14). There was no mortality. There were 6 (5.0%) complications: 1 intraoperative leak, 1 stricture, 1 trocar-site bleed, 1 renal failure, and 2 wound infections. There were no postoperative staple-line leaks. Following 15 concomitant hiatal hernia operations, 3 (20%) recurred: 1 revised to RYGB and 2 in standby. Two post-LSG hiatal hernias of the two-stage series required revisions because of symptoms. BMI decreased 24.7% at 6 months (n = 55) to 37.5 ± 9.3 (22.2-58.1); %EWL was 48.1 ± 19.3 (15.5-98.9). Twelve-month BMI (n = 41) was 38.4 ± 10.5 (19.3-62.3); %EWL was 51.7 ± 25.0 (8.9-123.3). Forty-eight-month BMI (n = 13) was 35.6 ± 6.8 (24.9-47.5); %EWL was 61.1 ± 12.2 (43.9-82.1) (p < 0.001). Preoperative BMI was predictive of >70% of patients who experienced <50% EWL at 6 months. At 2 weeks, 100% of type 2 diabetes patients (n = 23) were off medication (mean HbA(1C), 5.9 ± 0.5%; glycemia, 90.0 ± 19.9 mg/dL (p < 0.01) at 3 months). CONCLUSIONS: Laparoscopic PSD-reinforced LSG as a staged or definitive procedure is safe and effective in the short term and provides rapid type 2 diabetes mellitus reduction with a very low rate of complications.

Primary care and subspecialty management of morbid obesity: referral patterns for bariatric surgery.

BACKGROUND: The global rise in morbid obesity and associated comorbid diseases concerns a wide range of specialists. Although bariatric surgery has been proven to be an effective, enduring treatment available for morbid obesity, the rates of referral for surgery are not consistent with the number of individuals affected. METHODS: A survey of 478 experienced physicians from 6 specialty areas was conducted to ascertain the attitudes and practices regarding the treatment of morbidly obese patients. RESULTS: Approximately 21% (12% family practitioners and 34% internists) of patients seen by respondents were morbidly obese. Bariatric surgery was perceived as, by far, the most effective morbid obesity treatment available (judged to be effective for 49% of patients). Medical treatments were perceived as effective for <20% of patients (15% drugs and 23% exercise). Despite the respondents' perception that most surgery recipients achieve good to excellent long-term results, only 15.4% of patients were referred for consultation with a surgeon (8.0% for cardiologists and 26.1% for bariatricians). Most physicians were not knowledgeable regarding the National Institutes of Health morbid obesity management guidelines. Few could identify a local bariatric surgeon. The volume of referrals across all 6 specialty groups was low, at an average of 6 patients annually (3 patients for cardiologists and 19 patients for bariatricians). CONCLUSIONS: The results of our study have demonstrated that primary care physicians and subspecialists see a high proportion of morbidly obese patients; however, many are unfamiliar with morbid obesity management and surgical referral guidelines. Even though the perception of surgical effectiveness was quite high, the referrals for surgery were relatively low.

Evolution of operative procedures for the management of morbid obesity 1950-2000.

BACKGROUND: At the turn of the 21st century, obesity is the epidemic with the greatest prevalence in the United States. Fifteen million people, 1 out of 20, in this country have a body mass index (BMI) > or = 35 kgm2. Obesity is not only a medical problem, but also a social, psychological, and economic problem. At present, the morbidly obese are refractory to diet and drug therapy, but have a substantial, sustained weight loss after bariatric surgery. METHODS: This chronology of the landmark operations in bariatric surgery is based on a review of the medical literature. RESULTS: Bariatric surgery can be classified into 4 categories: malabsorptive procedures, malabsorptive/restrictive procedures, restrictive procedures, and other, experimental procedures. The prototype of malabsorptive procedures and the first operation performed specifically to induce weight loss was the jejunoileal bypass. The problems associated with this operation caused its demise. Today's popular malabsorptive procedures are the biliopancreatic diversion and the duodenal switch. Malabsorptive/restrictive surgery currently is predicated on the Roux-en-Y gastric bypass, both the traditional short-limb, and the long-limb for the super obese. Restrictive procedures are represented by the banded and ringed vertical gastroplasty, as well as gastric banding. Experimental procedures include gastric pacing. All of these operations can be performed by open surgery and laparoscopically. CONCLUSIONS: Since bariatric surgery is the only broadly successful treatment for morbid obesity, it is incumbent on all physicians to be familiar with current bariatric operations, and to understand the evolution of bariatric surgery.