Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. METHODS: The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. RESULTS: Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. CONCLUSIONS: The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

Pathophysiological Mechanisms of Gastro-esophageal Reflux After Sleeve Gastrectomy.

OBJECTIVE: To evaluate the mechanisms associated with reflux events after sleeve gastrectomy (SG). SUMMARY BACKGROUND DATA: Gastro-esophageal reflux (GERD) post-SG is a critical issue due to symptom severity, impact on quality of life, requirement for reoperation, and potential for Barrett esophagus. The pathophysiology is incompletely delineated. METHODS: Post-SG patients, stratified into asymptomatic and symptomatic, underwent protocolized nuclear scintigraphy (n = 83), 24-hour esophageal pH monitoring, and stationary manometry (n = 143) to characterize reflux patterns. Ten patients underwent fasting and postprandial concurrent manometry and pH for detailed analysis of reflux events. RESULTS: Baseline demographics between cohorts were similar: Age 47.2 ± 11.6 versus 44.1 ± 11.3 years ( P = 0.121); females 73.2% versus 90.8% ( P = 0.005); excess weight loss 53.8 ± 28.1% versus 57.4 ± 25.5% ( P = 0.422), follow-up duration 12.3 versus 7.4 months ( P = 0.503). Nuclear scintigraphy delineated bolus-induced deglutitive reflux events (29.6% vs 62.5%, P = 0.005) and postprandial reflux events [4 (IQR2) versus 4 (IQR 3) events, P = 0.356]. Total acid exposure was significantly elevated in the symptomatic population (7.7% vs 3.6%, P < 0.001), especially fasting acid exposure (6.0% vs 1.3%, P < 0.001). pH/manometry analysis demonstrated acute elevations of the gastro-esophageal pressure gradient (>10 mm Hg) underpinned most reflux events. Swallow-induced intragastric hyper-pressur-ization was associated with individual reflux events in most patients (90% in fasting state and 40% postprandial). CONCLUSIONS: We found reflux to be strongly associated with SG and identified 3 unique categories. Bolus-induced deglutitive and postprandial reflux occurred in most patients. Elevated fasting esophageal acid exposure mediated symptoms. Frequent, significant elevation in the gastro-esophageal pressure gradient was the mechanism of reflux and seemed to relate to the noncompliant proximal stomach.

The Evaluation of Gastric Emptying Using Nuclear Scintigraphy Compared to Three-Dimensional Multi-detector Computed Tomography (3D-MDCT) Gastric Volumetry in the Assessment of Poor Weight Loss Following Sleeve Gastrectomy.

BACKGROUND: Poor weight loss and weight regain are principal challenges following laparoscopic sleeve gastrectomy (LSG). There is a lack of standardised assessments and diagnostic tests to stratify the status post-LSG and determine whether anatomical or physiological problem exists. We aimed to compare nuclear scintigraphy gastric emptying with CT volumetric analysis of sleeve anatomy and determine the impact of anatomy on physiological function and its correlation with weight loss. MATERIALS AND METHODS: Patients greater than 12 months post-LSG were categorised into optimal weight loss (OWL) (n = 29) and poor weight loss groups (PWL) (n = 50). All patients underwent a protocolised nuclear scintigraphy and three-dimensional multi-detector computed tomography (3D-MDCT) gastric volumetry imaging. RESULTS: Post-operative % total weight loss in OWL was 26.2 ± 10.5% vs. 14.2 ± 10.7% in the PWL group (p value < 0.0001). The PWL group had significantly more delayed gastric emptying half-time than OWL (34.1 ± 18.8 vs. 19.5 ± 4.7, p value < 0.0001). Gastric emptying half-time showed statistically significant correlations with weight loss parameters (BMI; r = 0.215, p value 0.048, %EWL; r = - 0.336, p value 0.002 and %TWL; r = - 0.379, p value < 0.001). The median gastric volume on 3D-MDCT did not differ between the OWL (246 (IQR 50) ml) and PWL group (262 (IQR 129.5) ml), p value 0.515. Nuclear scintigraphy gastric emptying half-time was the most highly discriminant measure. A threshold of 21.2 min distinguished OWL from PWL patients with 86.4% sensitivity and 68.4% specificity. CONCLUSION: Nuclear scintigraphy is a potentially highly accurate tool in the functional assessment of sleeve gastrectomy physiology. It appears to perform better as a diagnostic test than volumetric assessment. Gastric volume did not correlate with weight loss outcomes. We have established diagnostic criteria of greater than 21 min to assess sleeve failure, which is linked to suboptimal weight loss outcomes.

Modified One Anastomosis Gastric Bypass Following Sleeve Gastrectomy for Severe Reflux and Delayed Gastric Emptying: A Prospective Trial with Clinical and Physiological Outcome Measures.

BACKGROUND: Gastro-esophageal reflux (GORD) following sleeve gastrectomy (SG) is a central challenge, and precise indications for revisional surgery or the physiology have not been precisely defined. We aimed to determine whether OAGB performed for reflux post-SG (1) accelerates gastric emptying half-time, (2) reduces the frequency and severity of reflux events, and (3) improves reflux symptoms. METHODS: We undertook a prospective trial (ACTRN12616001089426). There were 22 participants who underwent measurement before and after revisional surgery with 29 optimal SG (patients with optimal outcome from their primary surgery) as controls. All participants underwent a protocolized nuclear scintigraphy, 24-h pH monitoring, and gastroscopy and completed objective questionnaires. RESULTS: Trial patients were 90.9% female, age 44.4 years. Conversion from SG to OAGB was at a median of 45.2 ± 19.6 months. Scintigraphy showed an increased rate of gastric emptying post-OAGB 34 (IQR 14) vs 24 (IQR 10.3) min, p-value 0.008, with decreased number of reflux events post-prandially (39 (IQR 13) vs 26 (IQR 7), p-value 0.001). This data correlated with the pH analysis; total acid events substantially reduced post-OAGB 58.5 (IQR 88) vs 12 (IQR 9.4) events, p-value 0.017. Endoscopic findings indicated a reduction in incidence of bile stasis 72.7% vs 40.9% post-OAGB, p-value < 0.00010. Post-OAGB, patients experienced less frequent regurgitation (12 ± 4.1 vs. 5.5 ± 3, p-value 0.012) and reflux (37.1 ± 15.7 vs. 16.8 ± 12.6, p-value 0.003). CONCLUSIONS: We found OAGB is an effective treatment for reflux associated with delayed gastric emptying post-SG. The likely mechanisms is by, an increase in the rate of gastric clearance and reduced reflux events and overall esophageal acid exposure. This suggests that some forms of post-SG reflux are driven by slower emptying of the residual stomach and are amenable to treatment with drainage above the incisura.

Long-term Outcomes of Laparoscopic Sleeve Gastrectomy as a Revisional Procedure Following Adjustable Gastric Banding: Variations in Outcomes Based on Indication.

BACKGROUND: Significant controversy exists regarding the indications and outcomes after laparoscopic adjustable gastric banding (LAGB) conversions to laparoscopic sleeve gastrectomy (LSG). AIM: To comprehensively determine the long-term outcomes of sleeve gastrectomy as a revisional procedure after LAGB across a range of measures and determine predictors of outcomes. METHODS: Six hundred revision LSG (RLSG) and 1200 controls (primary LSG (PLSG)) were included. Patient demographics, complications, follow-up, and patient-completed questionnaires were collected. RESULTS: RLSG vs controls; females 87% vs 78.8%, age 45 ± 19.4 vs 40.6 ± 10.6 years, p = 0.561; baseline weight 119.7 ± 26.2 vs 120.6 ± 26.5 kg p = 0.961). Follow-up was 87% vs 89.3%. Weight loss in RLSG at 5 years, 22.9% vs 29.6% TBWL, p = 0.001, 10 years: 19.5% vs 27% TBWL, p = 0.001. RLSG had more complications (4.8 vs 2.0% RR 2.4, p = 0.001), re-admissions (4.3 vs 2.4% RR 1.8, p = 0.012), staple line leaks (2.5 vs 0.9%, p = 0.003). Eroded bands and baseline weight were independent predictors of complications after RLSG. Long-term re-operation rate was 7.3% for RLSG compared to 3.2% in controls. Severe oesophageal dysmotility predicted poor weight loss. RLSG reported lower quality of life scores (SF-12 physical component scores 75.9 vs 88%, p = 0.001), satisfaction (69 vs 93%, p = 0.001) and more frequent regurgitation (58% vs 42%, p = 0.034). CONCLUSION: RLSG provides long-term weight loss, although peri-operative complications are significantly elevated compared to PLSG. Longer-term re-operation rates are elevated compared to PLSG. Four variables predicted worse outcomes: eroded band, multiple prior bands, severe oesophageal dysmotility and elevated baseline weight.

Changes in Oesophageal Transit, Macro-Reflux Events, and Gastric Emptying Correlate with Improvements in Gastro-Intestinal Symptoms and Food Tolerance Early Post Sleeve Gastrectomy.

PURPOSE: There are significant alterations in gastro-intestinal function, food tolerance, and symptoms following sleeve gastrectomy (SG). These substantially change over the first year, but it is unclear what the underlying physiological basis for these changes is. We examined changes in oesophageal transit and gastric emptying and how these correlate with changes in gastro-intestinal symptoms and food tolerance. MATERIAL AND METHODS: Post-SG patients undertook protocolised nuclear scintigraphy imaging along with a clinical questionnaire at 6 weeks, 6 months, and 12 months. RESULTS: Thirteen patients were studied: mean age (44.8 ± 8.5 years), 76.9% females, pre-operative BMI (46.9 ± 6.7 kg/m2). Post-operative %TWL was 11.9 ± 5.1% (6 weeks) and 32.2 ± 10.1% (12 months), p-value < 0.0001. There was a substantial increase of meal within the proximal stomach; 22.3% (IQR 12%) (6 weeks) vs. 34.2% (IQR 19.7%) (12 months), p = 0.038. Hyper-accelerated transit into the small bowel decreased from 6 weeks 49.6% (IQR 10.8%) to 42.7% (IQR 20.5%) 12 months, p = 0.022. Gastric emptying half-time increased from 6 weeks 19 (IQR 8.5) to 12 months 27 (IQR 11.5) min, p = 0.027. The incidence of deglutitive reflux of semi-solids decreased over time; 46.2% (6 weeks) vs. 18.2% (12 months), p-value < 0.0001. Reflux score of 10.6 ± 7.6 at 6 weeks vs. 3.5 ± 4.4 at 12 months, (p = 0.049) and regurgitation score of 9.9 ± 3.3 at 6 weeks vs. 6.5 ± 1.7, p = 0.021 significantly reduced. CONCLUSIONS: These data demonstrate that there is an increase in the capacity of the proximal gastric sleeve to accommodate substrate over the first year. Gastric emptying remains rapid but reduce over time, correlating with improved food tolerance and reduced reflux symptoms. This is likely the physiological basis for the changes in symptoms and food tolerance observed early post-SG.

Delayed Gastric Emptying After Sleeve Gastrectomy Is Associated with Poor Weight Loss.

BACKGROUND: Intermediate to long-term weight regain is a major challenge following sleeve gastrectomy (SG). Physiological changes that mediate the extent of weight loss remain unclear. We aimed to determine if there were specific esophago-gastric transit and emptying alterations associated with weight regain. MATERIAL AND METHODS: Participants greater than 12 months post-SG were categorized into optimal (n = 29) and poor weight loss (PWL) (n = 72). All patients underwent a liquid contrast barium swallow demonstrating normal post-surgical anatomy and a protocolized nuclear scintigraphy designed specifically to characterize gastric emptying following SG. RESULTS: The %total weight loss in the optimal group was 26.2 ± 10.5 vs. 14.3 ± 8.8% in the PWL group (p = 0.001). Scintigraphy showed PWL had relatively increased gastric emptying half-time (GE 1/2t) 35 (IQR 23) min vs 19 (IQR 5.5) min (p = 0.001). The multivariate regressions delineated GE 1/2t as the best diagnostic measure for PWL (OR 1.16; CI 1.04-1.29, p-value 0.021). The probability of PWL increased by 16% for every 1-min increase above 21 min of GE 1/2t. A threshold of 21 min was found to have 88% sensitivity and 69% specificity predicting poor weight loss. CONCLUSION: Gastric emptying half-times greater than 21 min appear to reliably correlate with poor weight loss following SG. Additionally, further elevations above 21 min in emptying half-time increase the risk of poor weight loss. We have shown nuclear scintigraphy represents a simple and accurate diagnostic tool in patients who experience poor weight loss after SG, provided substantially altered reporting references in interpreting nuclear scintigraphy are applied.

Mechanisms of Esophageal and Gastric Transit Following Sleeve Gastrectomy.

PURPOSE: Sleeve gastrectomy (SG) patients have substantially altered anatomy. The mechanism of rapid gastric emptying and the role of esophageal contractile function in esophago-gastric transit has not been defined. We aimed to determine the mechanisms of esophago-gastric transit and role of esophageal function following sleeve gastrectomy. METHODS: Prospective study of twenty-six asymptomatic participants post SG underwent nuclear scintigraphy and high-resolution manometry. Fourteen had semi-solid stress barium to model the emptying process. Concurrent video fluoroscopy and manometry were performed on 7 participants. RESULTS: Demographic data are as follows: age 45.3 ± 15.0 years, 73.1% female, excess weight loss 62.2 ± 28.1% at 8 months. Scintigraphy showed rapid gastric emptying (24.4 ± 11.4 vs. 75.80 ± 45.19 min in control, p < 0.001) with 35.24 ± 17.12% of bolus transited into small bowel on initial frame. Triggered deglutitive reflux was common (54.4% vs. 18.2%, p = 0.017). Stress barium delineated separate vertical and antral gastric compartments with cyclical emptying of 8 stages, including reflux-induced repeated esophageal peristalsis. During manometry, ramping effects were noted, with sequential swallows producing sustained isobaric pressurizations in proximal stomach (33.6 ± 29.5 mmHg). Video fluoroscopy showed individual esophageal peristalsis generating pressurizations at 5.0 ± 1.4 cm below lower esophageal sphincter (LES), at amplitude of 31.6 ± 13.1 mmHg, associated with intragastric transit. Pressurizations were sustained for 17.3 ± 8.2 s, similar to the prolonged LES contraction (18.5 ± 9.0 s, p = 0.355). CONCLUSIONS: Repeated esophageal peristaltic contractions induced isobaric pressurization of proximal stomach, thus providing the drive to pressurize and empty the vertical compartment of the gastric sleeve. Transit following SG appeared to be esophageal-mediated and followed a distinct cycle with strong associations with reflux.