Updated: Aug 4
Earlier this year, Gore sponsored a live webinar symposium for EMEA and Australian surgeons which featured a panel of EMEA experts who discussed outpatient bariatric procedures, laparoscopic ventral hernia repair in conjunction with bariatric surgery and how to manage hiatal hernia defects during a sleeve gastrectomy procedure.* This discussion, based on the approved device indications for EMEA and Australia, presented education considerations for physicians in these regions.^
The expert panel was chaired by Dr. Salvador Morales-Conde, President-elect of the European Association of Endoscopic Surgeons and Chief of the Innovation Unit, Hospital Universitario Virgen del Rocío, Sevilla, Spain. Dr. Morales-Conde began the symposium by stating that from a surgeon’s standpoint it is crucial that they have the right material when performing laparoscopic reconstruction abdominal surgery (e.g., hernia repair) or when reinforcing the staple line (e.g., laparoscopic sleeve gastrectomy).
Prior to the clinical presentations, Thomas Mithieux, W. L. Gore & Associates, outlined some of the key properties of the company’s products for staple line reinforcement (GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement) and hiatal hernia reinforcement (GORE® BIO-A® Tissue Reinforcement). Both these devices are designed to support tissue regeneration and are comprised of a unique biosynthetic 3D web scaffold made of 67% polyglycolic acid (PGA) and 33% trimethylene carbonate (TMC). The highly interconnected pores facilitate tissue response over six to seven months during which time the material is constantly absorbed through hydrolysis.
“This combination of material and structure make our devices unique. As physicians, users and implanters of bioabsorbable synthetic devices, it is important you know the composition and structure of the device you will implant into your patients. Not all materials are the same, and therefore, may not have the same outcomes,” he explained.
Mithieux then showed scanning electron microscopes images of two buttressing materials clearly demonstrating the structural differences between the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement with fibres of around 26 μm in diameter and a device that is 100 percent PGA with fibres of around 9 μm in diameter. One study reported a device that is 100 percent PGA is more likely to have a faster degradation process leading to a higher inflammation in the early stages after implantation.‡
Mithieux added that the large, interconnected pore of the GORE® BIO-A® Tissue Reinforcement encourage the creation of the robust tissue layer, which is especially important in cases such as hiatal hernia that require rapid cell migration and vascularisation.
In summary, he said that the GORE® SEAMGUARD® Staple Line Reinforcement was launched in 1996 (made of PTFE) and then in 2003, the bioabsorbable version of GORE® SEAMGUARD® Staple Line Reinforcement was launched. Over four million devices have been implanted, and there are over 60 peer-reviewed papers published. For more than 10 years, over 105,000 hiatal configured Gore BIO-A Tissue Reinforcement devices were sold. Clinical literatures cites more than 1,000 hiatal hernia repairs performed using this device with no reports of erosion or infection (Data on file 2020, W. L. Gore & Associates, Inc; Flagstaff, AZ.)
Bariatric surgery as outpatient procedures
In the first presentation, Dr. Adriana Torcivia (general surgeon), Hôpital Pitié Salpêtrière, Paris, France, explained how her centre performs bariatric surgery as an outpatient (ambulatory or day care) procedure through their enhanced recovery after surgery (ERAS) programme. She cited a paper by Surve et al. (Surve A, Cottam D, Zaveri H, Cottam A, Belnap L, Richards C, Medlin W, Duncan T, Tuggle K, Zorak A, Umbach T, Apel M, Billing P, Billing J, Landerholm R, Stewart K, Kaufman J, Harris E, Williams M, Hart C, Johnson W, Lee C, Lee C, DeBarros J, Orris M, Schniederjan B, Neichoy B, Dhorepatil A, Cottam S, Horsley B. Does the future of laparoscopic sleeve gastrectomy lie in the outpatient surgery center? A retrospective study of the safety of 3162 outpatient sleeve gastrectomies. Surg Obes Relat Dis. 2018 Oct;14(10):1442-1447), that concluded outpatient laparoscopic sleeve gastrectomy centres are a viable option for patients with minimal surgical risks after they reported a short-term complications rate of 2.5 percent and a readmission rate of 0.6 percent from 3,162 patients who underwent primary laparoscopic sleeve gastrectomy procedure at outpatient surgery centres.
An additional study (Rebibo L, Dhahri A, Badaoui R, Dupont H, Regimbeau JM. Laparoscopic sleeve gastrectomy as day-case surgery (without overnight hospitalization). Surg Obes Relat Dis. 2015 Mar-Apr;11(2):335-42) reported high levels of patient satisfaction and post-operative similar to patient in conventional hospitalisation.
And a further study found that ERAS protocol for laparoscopic sleeve gastrectomy results in shorter length of stay, without increase in peri-operative morbidity or readmission rates, and was cost-effective (Lam J, Suzuki T, Bernstein D, Zhao B, Maeda C, Pham T, Sandler BJ, Jacobsen GR, Cheverie JN, Horgan S. An ERAS protocol for bariatric surgery: Is it safe to discharge on post-operative day 1? Surg Endosc. 2019 Feb;33(2):580-586).
She reported that her hospital has a building, specifically designed, built and dedicated to ambulatory surgery. This is one of the most important factors in the success of the programme as this avoids unnecessary postponements or cancellations of surgery.
Dr. Torcivia and colleagues established their ambulatory programme in 2017 and follow the standard inclusion and exclusion criteria for bariatric surgery (BMI, age, well-motivated patients, psychosocial context, diabetes and smoking status, immunosuppression, etc.), adding that good patient selection is one of the most important factors for favourable outcomes. In the first 30 patients, they had two re-admissions for hyperglycaemia and hypertension, as a result they decided to exclude patients who were taking more than one medication for diabetes. Due to medical and psychological issues, as well as patient refusal, the centre currently has a recruitment figure of around 15 percent.
The first stage for a patient going through the programme is surgical consultation to assess the patient’s suitability and provide them with all the information they will need, i.e., details of the programme and the postoperative objectives. The second stage is a second evaluation with a medico-social assessment and a re-explanation of the programme, delivery of explanatory notices and an assessment of any post-hospitalisation needs, which she added underpins the patient’s trust in the centre. On the day of surgery, the patient undergoes an anaesthesia evaluation to prevent hypothermia, as well as morphine and corticosteroid therapy, antibiotic prophylaxis and thromboembolic prevention.
The minimally-invasive procedure is performed with as little aggression as possible and without drains, a nasogastric tube or a urinary catheter. To minimise the risk of post-operative leaks and bleeding, they utilise the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement that is supported by the medical literature (Gayrel X, Loureiro M, Skalli EM, Dutot C, Mercier G, Nocca D. Clinical and Economic Evaluation of Absorbable Staple Line Buttressing in Sleeve Gastrectomy in High-Risk Patients. Obes Surg. 2016 Aug;26(8):1710-6).
Post-surgery, the patient can have water and chewing gum to accelerate intestinal transit and is allowed to return to their room whether standing, sitting or lying down. They perform standard postoperative analgesia for pain with non-steroidal anti-inflammatory drugs. The patient is discharged if their pain is controlled, they can eat without nausea or vomiting, independent mobilisation, no signs of infection, stable hemodynamic parameters and little chance of hospitalisation and if they accept discharge. The patient is also given a symptoms list (fever, pain, tachycardia, etc.) and if they develop any they are told they must return to the hospital.
The nurse calls the patient on day one and they have access to a 24/7 hot line, a home nurse administers low-molecular-weight heparin, they have a biological assessment on day two and a surgical consultation appointment is planned after day three.
Dr. Torcivia explained that the success of the centre’s outpatient programme is a highly-focused multi-disciplinary team, standard protocols, good patient selection and prioritised re-admission.
“May we dare to propose a dogma in bariatric surgery?” she asked. “When possible, ERAS surgery should be the norm.”
Laparoscopic ventral hernia repair
Next, Dr. ssa Berta Rossana Berta (bariatric and metabolic surgeon), Nuova Santa Chiara University Hospital, Pisa, Italy, examined the role of laparoscopic ventral hernia repair in bariatric patients. She began by stating that incisional and primary ventral hernias are two of almost two-hundred comorbidities of obesity, with more than 60 percent of patients with ventral hernias presenting as overweight or obese, and ventral hernias are present in 8-10 percent of patients undergoing bariatric surgery. In addition, small bowel obstruction secondary to incarcerated ventral hernia can be a fatal complication immediately after bariatric surgery causing an anastomotic leak or further fatal complications after thirty days, she added.
There is high risk of complication and recurrence in patients with obesity who have undergone ventral hernia repair and increased BMI is associated with operative, medical and respiratory complications after ventral hernia repair surgery (Owei L, Swendiman RA, Kelz RR, Dempsey DT, Dumon KR. Impact of body mass index on open ventral hernia repair: A retrospective review. Surgery. 2017 Dec;162(6):1320-1329 and Zavlin D, Jubbal KT, Van Eps JL, Bass BL, Ellsworth WA 4th, Echo A, Friedman JD, Dunkin BJ. Safety of open ventral hernia repair in high-risk patients with metabolic syndrome: a multi-institutional analysis of 39,118 cases. Surg Obes Relat Dis. 2018 Feb;14(2):206-213).
“We know that patients with a BMI over 40 have twice the risk of complications after ventral hernia repair and the presence of metabolic syndrome – diabetes, hypertension, etc. – is related to unfavourable outcomes and increased mortality after ventral hernia repair, compared with patients with no metabolic syndrome,” Dr. ssa Berta explained. “Although weight loss can improve outcomes, to date, there is no consensus on the best timing and treatment option for this group of patients.”
Ventral hernia repair can be performed before, during and after bariatric surgery and a review of 11 papers reported that repair during bariatric surgery was feasible and safe for a small ventral hernia defect (Andrea Lazzati, Georges Bou Nassif, Luca Paolino. Concomitant Ventral Hernia Repair and Bariatric Surgery: a Systematic Review. Obes Surg. .2018 Sep;28(9):2949-2955. doi: 10.1007/s11695-018-3366-x). No significant differences were identified between primary repair and the use of synthetic or biologic mesh in terms of mortality and morbidity, although synthetic mesh resulted in lower recurrence and mesh infection rates.
In addition, a paper published in 2019 by Krivan (Krivan MS, Giorga A, Barreca M, Jain VK, Al-Taan OS. Concomitant ventral hernia repair and bariatric surgery: a retrospective analysis from a UK-based bariatric center. Surg Endosc. 2019 Mar;33(3):705-710), reported synchronous ventral hernia repair and bariatric surgery is feasible with low recurrence rate and the laparoscopic technique had lower complication rates verses open. In addition, Shabanzadeh et al., found that laparoscopic surgery reduced the surgical site infection rate by 70-80 percent (Shabanzadeh DM, Sørensen LT. Laparoscopic surgery compared with open surgery decreases surgical site infection in obese patients: a systematic review and meta-analysis. Annals of Surgery. 2012 Dec;256(6):934-945). However, Krivan and colleagues also reported that higher BMI and a ventral hernia larger than 5 cm have a greater incidence of recurrence and wound related complications. Dr. ssa Berta suggested that such patients might benefit from deferred ventral hernia repair.
The American Society for Metabolic and Bariatric Surgery and American Hernia Society have published a consensus guideline on bariatric surgery and hernia surgery (Menzo EL, Hinojosa M, Carbonell A, Krpata D, Carter J, Rogers AM. American Society for Metabolic and Bariatric Surgery and American Hernia Society consensus guideline on bariatric surgery and hernia surgery. Surg Obes Relat Dis. 2018 Sep;14(9):1221-1232) and reported that “…in patients with severe obesity and ventral hernia, and both being amenable to laparoscopic repair, combined hernia repair and bariatric surgery may be safe; however in these patients where laparoscopic repair is not amenable, a staged approach is recommended. Weight loss prior to hernia repair is likely to improve hernia repair outcomes.”