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The completed consent form in patients undergoing bariatric surgery: Is it fit for purpose? A study from a Regional Bariatric Centre in the United Kingdom
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Poster Presentations / Surgery for Obesity and Related Diseases 11 (2015) S56–S211
cases: Fourteen (15.5%) with sludge, 15 (16.6%) asymptomatic gallstones, and 4 (4.4%) symptomatic gallstones. During followup, nine patients were excluded (6 without ultrasound and 3 lost of follow-up), and 4 (4.9%) required simultaneous cholecystectomy because of symptomatic gallstones. The final analysis was based on 77 patients; female sex comprised 80.2% of cases with a mean age of 37.6 years. The complete analysis is shown in Table 1. After 12 months, de novo gallbladder disease was observed in 18 patients (37.5%): Sludge in 11 (61.1%), asymptomatic gallstones in 4 (8.3%) and symptomatic gallstones in 3 (6.2%). The evolution of patients with preoperative sludge was: Ten (71.4%) still with sludge, three (21.4%) developed asymptomatic gallstones and one (7.1%) symptomatic gallstones. The evolution of 15 patients (19.4%) with preoperative asymptomatic cholelithiasis was: Fourteen (93.3%) remained asymptomatic, and only 1 patient (6.6%) required surgery. (Figure1) The overall rate of cholecystectomy because of symptomatic disease after 12 months was 6.4% (5 patients): Three without initial disease, one with preoperative sludge, and one with preoperative gallstones. From these patients, two required emergency surgery for cholecystitis. There were no differences in %EWL between patients with de novo gallbladder disease and those without (73.5 ⫾ 16.7% vs. 82.5 ⫾ 11.5% respectively; p 0.115). For those having preoperative asymptomatic disease, there were no differences in %EWL between patients that presented further symptoms or not (74.8 ⫾ 6.5% vs 80.9 ⫾15% respectively; p¼0.337). Conclusion: Conservative management of asymptomatic gallbladder disease in candidates to bariatric surgery is safe and can be offered to every patient, based on the low percentage of patients requiring further cholecystectomy after 12 months. Also, a conservative management can be offered to patients developing de novo sludge/cholelithiasis without related symptoms. Longer follow-up and more patients enrolled are necessary to make a final statement.
A5137
BARIATRIC SURGERY PATIENT PERCEPTIONS AND WILLINGNESS TO CONSENT TO RESIDENT PARTICIPATION John McClellan, MD; Daniel Nelson, DO; Matthew Martin, MD; Madigan Army Medical Center, Tacoma, WA, USA Background: Many bariatric surgery programs are located at teaching hospitals where they are integral to the training of surgical residents. Integrating surgical trainees requires an often difficult balance of the training needs of the resident versus maximizing patient safety and outcomes, and patient’s may have little understanding or appreciation of this process. The purpose of this study was to examine bariatric patient perceptions and willingness to participate in resident education and assess the effect on patient willingness and consent rates. Methods: Anonymous questionnaire given to bariatric patients in preoperative appointment at tertiary-level referral center with a 6year residency program. It is designed to capture demographics, overall opinions of teaching programs, and willingness to consent to various scenarios of trainee participation. Results: 100 patients completed the questionnaire, 75% were female and 52% were planning on proceeding with sleeve
gastrectomy as their procedure of choice. Most patients expressed overall support for their procedure being performed at a teaching hospital with 92% feeling that their care would be equivalent to or better than that of a private hospital. However, only 63% of the patients would definitely consent to having either interns or residents involved in their operation. When presented with several realistic scenarios with different levels of trainee involvement in their surgery, there was marked variation in the consent rates (low of 15% to high of 87%). Only 45% would consent to an intern assisting with their procedure, while 78% would consent to a senior resident (po0.05). Most patients (95%) felt they should be informed of the exact year of the resident performing the procedure and also be specifically informed if this was the resident’s first time performing the procedure. Factors independently associated with willingness to consent to resident participation included having a prior surgery performed at a teaching hospital (odds ratio 3.6) and expressing a feeling of providing benefit to other’s by participating in resident training (odds ratio 5.5, both po0.05). Conclusions: Overall, patients expressed support for the teaching hospital model and resident education and participation. However, their willingness to consent to specific realistic scenarios involving various levels of resident participation in their surgery ranged widely, and decreased for lower level trainees and for increased levels of active resident participation. Although providing detailed informed consent is preferred by patients, it has the potential to negatively impact resident participation and training.
A5138
THE COMPLETED CONSENT FORM IN PATIENTS UNDERGOING BARIATRIC SURGERY: IS IT FIT FOR PURPOSE? A STUDY FROM A REGIONAL BARIATRIC CENTRE IN THE UNITED KINGDOM Karim Sillah, MD1; Victoria Wilkinson-Smith, BM BS2; Altaf Awan, MD2; Paul Leeder, MBChB, MD, FRCS2; Sherif Awad, FRCS2; 1Royal Derby Hospital, Derby, UK; 2Royal Derby Hospital, EMBMI, Derby, Derbyshire, UK Background: Laparoscopic gastric bypass (LGB) and sleeve gastrectomy (LSG) for morbid obesity are complex procedures that may result in occurrence of serious perioperative complications. A thorough preoperative informed consent process is paramount in this population of patients, most of which have numerous baseline co-morbidities. We studied the consistency and adequacy of completed operative consent forms with a view to identifying areas for improvement. Methods: Completed operative consent forms from consecutive patients who underwent LGB and LSG from Apr 13 to Apr 14 in a regional bariatric centre in the United Kingdom were studied. The adequacy of consent forms was determined by comparing the benefits and risks documented on forms against a standardised list of 22 variables complied during a consensus meeting of the bariatric multi-disciplinary team. Results: 109 patients (mean⫾SD age 46⫾11 years) were included of whom 88 (81%) underwent LGB. Of the 22 variables, the mean⫾SD number of variables documented by Consultant Surgeons was 10.7⫾1.9 compared to 10.6⫾1.5 by trainees. Variables such as benefits of surgery, postoperative bleeding and infection
Poster Presentations / Surgery for Obesity and Related Diseases 11 (2015) S56–S211
were documented in all consent forms. Other variables were documented less frequently: anastomotic/staple line leak (86%), DVT/PE (82%), malnutrition (78%), strictures (76%), death (75%), internal hernia (65%) and weight regain (58%). Less frequently discussed risks included: esophageal perforation (13.8%), marginal ulcers (11%), visceral injury (8.2%), excess skin (8.2%), and reoperation (2.8%). Only 28% of patients were consented for conversion to open surgery. Conclusions: Our study demonstrated much variability and inadequacies in completion of operative consent forms. Given the high-risk patient population, complex surgery, and potential for litigation for surgeons undertaking bariatric procedures, use of preprinted consent forms should eliminate variability and reduce the risk of omitting important risks.
A5139
VARIABILITY IN BARIATRIC CLINICAL PATHWAYS: ASSESSING NATIONAL PROVISION OF CARE Dana Telem, MD1; Saniea Majid, MD, FACS2; Kinga Powers, MD PhD3; Eric DeMaria, MD4; John Morton, MD5; Daniel Jones, MD6; 1Stony Brook, NY, USA; 2Newark, NJ, USA; 3 Roanoke, VA, USA; 4Suffolk, VA, USA; 5Stanford CA; 6Boston, MA, USA Background: The Quality Improvement and Patient Safety (QIPS) Committee supports the mission and values of the American Society of Metabolic and Bariatric Surgeons (ASMBS) by promoting continuous improvement in patient safety and risk reduction. These goals are achieved by the integration and
Table 1: Binary assessment (present versus absent) of whether a variable was mentioned or accounted for in clinical pathway, (n=31). Variable Preoperative Duration preoperative liquid diet Endoscopy Obstructive Sleep Apnea evaluation Bowel Preparation H. Pylori Testing Mandatory preoperative weight loss Cardiac evaluation Chest x-ray Nutritional Evaluation Psychological Evaluation DVT screening Intraoperative DVT prophylaxis Foley catheter Patient positioning Antibiotics Non penicillin allergic Penicillin allergic Drains Nasogastric tube Intra-abdominal drain Leak test Intraoperative endoscopy Staple line reinforcement Bougie use Distance from pylorus (sleeve) Postoperative Anti-emetics DVT prophylaxis Duration Initiation of diet Anticipated length of stay Duration of postoperative diet Acid suppressing medication Postoperative UGI Pain management pathway Immediate postoperative monitoring Postoperative laboratory studies Time to first postoperative visit
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Pathways Stated (%)
Routine (%)
Selective (%)
35.5 25.8 51.6 22.6 29.1 6.5 58.1 51.6 71 67.4 22.6
n/a 9.7 9.7 16.1 19.4 6.5 6.5 41.9 71 64.5 22.6
n/a 16.1 41.7 6.5 9.7 0 51.6 9.7 0 3.2 0
83.9 58.1 32.2
80.9 22.6 n/a
3.9 35.5 n/a
48.4 32.2
48.4 32.2
0 0
12.9 35.5 22.6 12.9 9.7 9.7 6.5
3.2 22.6 n/a n/a n/a n/a n/a
9.7 12.9 n/a n/a n/a n/a n/a
83.9 61.2 41.9 51.6 58.1 35.5 35.5 58.1 74.2 38.7 77.4 54.9
38.7 n/a n/a n/a n/a n/a 29 38.7 n/a n/a n/a n/a
45.2 n/a n/a n/a n/a n/a 6.5 19.4 n/a n/a n/a n/a
Poster Presentations / Surgery for Obesity and Related Diseases 11 (2015) S56–S211
cases: Fourteen (15.5%) with sludge, 15 (16.6%) asymptomatic gallstones, and 4 (4.4%) symptomatic gallstones. During followup, nine patients were excluded (6 without ultrasound and 3 lost of follow-up), and 4 (4.9%) required simultaneous cholecystectomy because of symptomatic gallstones. The final analysis was based on 77 patients; female sex comprised 80.2% of cases with a mean age of 37.6 years. The complete analysis is shown in Table 1. After 12 months, de novo gallbladder disease was observed in 18 patients (37.5%): Sludge in 11 (61.1%), asymptomatic gallstones in 4 (8.3%) and symptomatic gallstones in 3 (6.2%). The evolution of patients with preoperative sludge was: Ten (71.4%) still with sludge, three (21.4%) developed asymptomatic gallstones and one (7.1%) symptomatic gallstones. The evolution of 15 patients (19.4%) with preoperative asymptomatic cholelithiasis was: Fourteen (93.3%) remained asymptomatic, and only 1 patient (6.6%) required surgery. (Figure1) The overall rate of cholecystectomy because of symptomatic disease after 12 months was 6.4% (5 patients): Three without initial disease, one with preoperative sludge, and one with preoperative gallstones. From these patients, two required emergency surgery for cholecystitis. There were no differences in %EWL between patients with de novo gallbladder disease and those without (73.5 ⫾ 16.7% vs. 82.5 ⫾ 11.5% respectively; p 0.115). For those having preoperative asymptomatic disease, there were no differences in %EWL between patients that presented further symptoms or not (74.8 ⫾ 6.5% vs 80.9 ⫾15% respectively; p¼0.337). Conclusion: Conservative management of asymptomatic gallbladder disease in candidates to bariatric surgery is safe and can be offered to every patient, based on the low percentage of patients requiring further cholecystectomy after 12 months. Also, a conservative management can be offered to patients developing de novo sludge/cholelithiasis without related symptoms. Longer follow-up and more patients enrolled are necessary to make a final statement.
A5137
BARIATRIC SURGERY PATIENT PERCEPTIONS AND WILLINGNESS TO CONSENT TO RESIDENT PARTICIPATION John McClellan, MD; Daniel Nelson, DO; Matthew Martin, MD; Madigan Army Medical Center, Tacoma, WA, USA Background: Many bariatric surgery programs are located at teaching hospitals where they are integral to the training of surgical residents. Integrating surgical trainees requires an often difficult balance of the training needs of the resident versus maximizing patient safety and outcomes, and patient’s may have little understanding or appreciation of this process. The purpose of this study was to examine bariatric patient perceptions and willingness to participate in resident education and assess the effect on patient willingness and consent rates. Methods: Anonymous questionnaire given to bariatric patients in preoperative appointment at tertiary-level referral center with a 6year residency program. It is designed to capture demographics, overall opinions of teaching programs, and willingness to consent to various scenarios of trainee participation. Results: 100 patients completed the questionnaire, 75% were female and 52% were planning on proceeding with sleeve
gastrectomy as their procedure of choice. Most patients expressed overall support for their procedure being performed at a teaching hospital with 92% feeling that their care would be equivalent to or better than that of a private hospital. However, only 63% of the patients would definitely consent to having either interns or residents involved in their operation. When presented with several realistic scenarios with different levels of trainee involvement in their surgery, there was marked variation in the consent rates (low of 15% to high of 87%). Only 45% would consent to an intern assisting with their procedure, while 78% would consent to a senior resident (po0.05). Most patients (95%) felt they should be informed of the exact year of the resident performing the procedure and also be specifically informed if this was the resident’s first time performing the procedure. Factors independently associated with willingness to consent to resident participation included having a prior surgery performed at a teaching hospital (odds ratio 3.6) and expressing a feeling of providing benefit to other’s by participating in resident training (odds ratio 5.5, both po0.05). Conclusions: Overall, patients expressed support for the teaching hospital model and resident education and participation. However, their willingness to consent to specific realistic scenarios involving various levels of resident participation in their surgery ranged widely, and decreased for lower level trainees and for increased levels of active resident participation. Although providing detailed informed consent is preferred by patients, it has the potential to negatively impact resident participation and training.
A5138
THE COMPLETED CONSENT FORM IN PATIENTS UNDERGOING BARIATRIC SURGERY: IS IT FIT FOR PURPOSE? A STUDY FROM A REGIONAL BARIATRIC CENTRE IN THE UNITED KINGDOM Karim Sillah, MD1; Victoria Wilkinson-Smith, BM BS2; Altaf Awan, MD2; Paul Leeder, MBChB, MD, FRCS2; Sherif Awad, FRCS2; 1Royal Derby Hospital, Derby, UK; 2Royal Derby Hospital, EMBMI, Derby, Derbyshire, UK Background: Laparoscopic gastric bypass (LGB) and sleeve gastrectomy (LSG) for morbid obesity are complex procedures that may result in occurrence of serious perioperative complications. A thorough preoperative informed consent process is paramount in this population of patients, most of which have numerous baseline co-morbidities. We studied the consistency and adequacy of completed operative consent forms with a view to identifying areas for improvement. Methods: Completed operative consent forms from consecutive patients who underwent LGB and LSG from Apr 13 to Apr 14 in a regional bariatric centre in the United Kingdom were studied. The adequacy of consent forms was determined by comparing the benefits and risks documented on forms against a standardised list of 22 variables complied during a consensus meeting of the bariatric multi-disciplinary team. Results: 109 patients (mean⫾SD age 46⫾11 years) were included of whom 88 (81%) underwent LGB. Of the 22 variables, the mean⫾SD number of variables documented by Consultant Surgeons was 10.7⫾1.9 compared to 10.6⫾1.5 by trainees. Variables such as benefits of surgery, postoperative bleeding and infection
Poster Presentations / Surgery for Obesity and Related Diseases 11 (2015) S56–S211
were documented in all consent forms. Other variables were documented less frequently: anastomotic/staple line leak (86%), DVT/PE (82%), malnutrition (78%), strictures (76%), death (75%), internal hernia (65%) and weight regain (58%). Less frequently discussed risks included: esophageal perforation (13.8%), marginal ulcers (11%), visceral injury (8.2%), excess skin (8.2%), and reoperation (2.8%). Only 28% of patients were consented for conversion to open surgery. Conclusions: Our study demonstrated much variability and inadequacies in completion of operative consent forms. Given the high-risk patient population, complex surgery, and potential for litigation for surgeons undertaking bariatric procedures, use of preprinted consent forms should eliminate variability and reduce the risk of omitting important risks.
A5139
VARIABILITY IN BARIATRIC CLINICAL PATHWAYS: ASSESSING NATIONAL PROVISION OF CARE Dana Telem, MD1; Saniea Majid, MD, FACS2; Kinga Powers, MD PhD3; Eric DeMaria, MD4; John Morton, MD5; Daniel Jones, MD6; 1Stony Brook, NY, USA; 2Newark, NJ, USA; 3 Roanoke, VA, USA; 4Suffolk, VA, USA; 5Stanford CA; 6Boston, MA, USA Background: The Quality Improvement and Patient Safety (QIPS) Committee supports the mission and values of the American Society of Metabolic and Bariatric Surgeons (ASMBS) by promoting continuous improvement in patient safety and risk reduction. These goals are achieved by the integration and
Table 1: Binary assessment (present versus absent) of whether a variable was mentioned or accounted for in clinical pathway, (n=31). Variable Preoperative Duration preoperative liquid diet Endoscopy Obstructive Sleep Apnea evaluation Bowel Preparation H. Pylori Testing Mandatory preoperative weight loss Cardiac evaluation Chest x-ray Nutritional Evaluation Psychological Evaluation DVT screening Intraoperative DVT prophylaxis Foley catheter Patient positioning Antibiotics Non penicillin allergic Penicillin allergic Drains Nasogastric tube Intra-abdominal drain Leak test Intraoperative endoscopy Staple line reinforcement Bougie use Distance from pylorus (sleeve) Postoperative Anti-emetics DVT prophylaxis Duration Initiation of diet Anticipated length of stay Duration of postoperative diet Acid suppressing medication Postoperative UGI Pain management pathway Immediate postoperative monitoring Postoperative laboratory studies Time to first postoperative visit
S129
Pathways Stated (%)
Routine (%)
Selective (%)
35.5 25.8 51.6 22.6 29.1 6.5 58.1 51.6 71 67.4 22.6
n/a 9.7 9.7 16.1 19.4 6.5 6.5 41.9 71 64.5 22.6
n/a 16.1 41.7 6.5 9.7 0 51.6 9.7 0 3.2 0
83.9 58.1 32.2
80.9 22.6 n/a
3.9 35.5 n/a
48.4 32.2
48.4 32.2
0 0
12.9 35.5 22.6 12.9 9.7 9.7 6.5
3.2 22.6 n/a n/a n/a n/a n/a
9.7 12.9 n/a n/a n/a n/a n/a
83.9 61.2 41.9 51.6 58.1 35.5 35.5 58.1 74.2 38.7 77.4 54.9
38.7 n/a n/a n/a n/a n/a 29 38.7 n/a n/a n/a n/a
45.2 n/a n/a n/a n/a n/a 6.5 19.4 n/a n/a n/a n/a