Identification of Local Problem
Review of our institution’s Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) semiannual report noted higher instances of reoperations following laparoscopic sleeve gastrectomy (SG). Our expected rate of laparoscopic SG bleeding was 0.45%, our Observed rate was 1.34%. Laparoscopic SG All-cause Reoperation and Related Reoperation expected rates were 0.42% and 0.40%, respectively. Our observed rates for All-cause and related reoperations were 1.47% and 1.70%, respectively. Due to these high outliers, our institution’s bariatric surgeons developed a quality improvement project addressing two periods of review, one prior to a standardized intervention and one post-intervention. This study sought to standardize practice across surgeons and reduce the instance of reoperation for bleeding following SG.
Context of the QI Activity
This project was completed using the Plan, Do, Study, Act method. Two review periods were determined: October 2022–June 2023 (before standardization) and August 2023–March 2024 (after standardization). During the initial review period, surgeons were primarily using a hybrid robotic and laparoscopic approach to SG in which the dissection was performed with the robot before returning to the bedside to complete the sleeve with laparoscopic stapler. A peer review along with manufacturer recommendation from industry vendors were used to develop our technique using 1–2 blue loads (3.5mm staple height) based on indications of tissue thickness and feedback from the robot during stapler firing followed by white loads (2.5mm staple height) to complete the sleeve.
SMART Goal
Specific: Reduce number of reoperations for bleeding following SG.
Measurable: Compare institutional MBSAQIP data prior to and after intervention.
Achievable: Reduce percentage of reoperations from initial 4.67% to near 0% with standardized surgical approach and staple height use.
Relevant: Bleeding after SG is associated with increased complications, readmission and reoperation rates, and mortality at 30 days. Our institution aims to continually improve upon surgical technique and patient safety using evidence-based methods. With a reduction in bleeds post SG, we would be able to decrease patient mortality and complication rate from a second operation.
Timeline: October 2022–June 2023 (before standardization), and August 2023–March 2024 (after standardization).
What were the interventions?
The intervention performed included standardizing procedure with an entirely robotic approach, avoiding the use of a hybrid robotic-laparoscopic SG. Prior to standardization, our institution primarily utilized all blue staple loads. Through our research we realized surgeons weren’t using that many blue loads, and that it may be more appropriate to use white. We hypothesized that using a taller staple on thinner tissue would then not allow for appropriate compression of the vessels, possibly leading to more bleeding. Standardization of the staples consisted of using 1-2 taller blue loads and using white loads for the remainder, or in certain cases, all white load, based on indications of tissue thickness and feedback from the robot. The tissue of the antrum is usually a little thicker than the body of the stomach, averaging 5-7mm vs 2-3mm in the body of the stomach, so we anticipated using a taller, thicker blue load (3.5mm) for this thicker tissue. As the robot closes and prepares to fire it will pause if the tissue is particularly thick. If that is the case, then we use one more blue staple before transitioning to using white staple loads (2.5mm).
Improvement Team
Our improvement team consisted of all 3 of our institution’s bariatric surgeons Dr. Renee Hilton, Dr. Aaron Bolduc, and Dr. Jaine McKenzie. Our project champion is Dr. Renee Hilton, Director of Wellstar MCG Health Center for Obesity and Metabolism. We worked alongside the Bariatric Program Coordinator, Bryn Hamilton, RD, CSOWM, LD, to assess and analyze the data.
Overall Results and Analysis
In the pre-intervention period, 5 out of 107 cases (4.67%) required reoperation; 80% were due to staple line bleeds. The cases were made up of 3 hybrid techniques and 1 robotic sleeve. In the post-intervention period, 1 out of 56 SG required reoperation for bleeding on a sleeve performed laparoscopically. Amongst the standardized robotic sleeves, there were zero postoperative bleeding episodes. Sixty-nine percent of robotic cases used additional interventions such as clips or oversewing staple lines at the index operation, and 31% did not require additional intervention. Study observations were that robotic staples are not reinforced as laparoscopic staples are. Therefore, additional interventions such as oversewing were required likely due to non-reinforced staples. This is concurrent with current literature suggesting that staple-line reinforcement techniques independently predict a lower risk of postoperative bleeding after SG2. There is a need for reinforced staples for robotic stapler.
Limitations
Limitations of our study include using staples from one main industry vendor which is supplied by our institution. However, this industry vendor is one of 2 dominating distributors for staples nationwide3. Another concern as a cause for staple-line bleeds is possible trauma due to staple misfiring. This is a rare event across all industry vendor staples3. However this issue was not addressed in our study.
Unintended Consequences
Unintended consequences of our study are that moving forward we have an obligation to utilize the evidence uncovered; however, we are unable to do so as efficiently as possible without pre-made reinforced staples for the robotic stapler. This puts the responsibility back on the surgeon to ensure that robotic staples are effectively secured by oversewing or adding additional clips which is a practice that has not yet been standardized and will presumably vary patient to patient, and surgeon to surgeon.
Key Takeaways
Overall, standardization of technique for sleeve gastrectomy decreased re-operations for bleeding. An additional observation was reinforcement of robotic staple lines was performed in most cases and likely contributed to the reduction. As stated earlier, other studies have also found that staple-line reinforcement and staple-line oversewing are protective for bleeding. Our study suggests that continuing with the robotic stapling technique will help to keep post-operative bleed events at or near zero. By adopting and adhering to robotic-only, reinforced staple lines we create an opportunity to reduce morbidity and mortality in patients undergoing a sleeve gastrectomy.
