Can a Quality Collaborative Build Value in Global Surgery? Results From a Single State Experience.

BACKGROUND: Surgery is a critical component of global health care worldwide. Little is known about global surgery participation among surgeons in Connecticut. The goal of this pilot survey project was to determine the breadth of global surgery experience in our state. STUDY DESIGN: An electronic survey was distributed to surgeons in the state of Connecticut via the Connecticut Chapter of the American College of Surgeons (CTACS) and to departments of surgery throughout the state. RESULTS: Seventy-four surgeons and surgical residents completed the online survey from 17 different hospitals. Nineteen (25.7%) of the respondents had participated in global surgery. Most participated in yearly (56.3%), short-term experiences (94.5%). Nearly half of this group reported no formal record of outcomes (52.9%), but 17/19 (89.5%) respondents reported that accurate outcomes measures are beneficial to surgical care in resource-poor areas. Eighty-nine percent reported a willingness to participate in a surgical quality and outcomes database. CONCLUSION: A substantial proportion of surgeons in Connecticut participate in global surgery. Most surgeons value qualityin surgical care, yet outcomes are not routinely measured. This discordance may be addressed through the development of a quality improvement collaborative for global surgery.

Thirty-day outcomes support implementation of a surgical safety checklist.

BACKGROUND: Thirty-day postoperative complications from unintended harm adversely affect patients and their families and increase institutional health care costs. A surgical checklist is an inexpensive tool that will facilitate effective communication and teamwork. Surgical team training has demonstrated the opportunity for stakeholders to professionally engage one another through leveling of the authority gradient to prevent patient harm. The American College of Surgeons National Surgical Quality Improvement Program database is an outcomes reporting tool capable of validating the use of surgical checklists. STUDY DESIGN: Three 60-minute team training sessions were conducted and participants were oriented to the use of a comprehensive surgical checklist. The surgical team used the checklist for high-risk procedures selected from those analyzed for the American College of Surgeons National Surgical Quality Improvement Program. Trained observers assessed the checklist completion and collected data about perioperative communication and safety-compromising events. RESULTS: Data from the American College of Surgeons National Surgical Quality Improvement Program were compared for 2,079 historical control cases, 246 cases without checklist use, and 73 cases with checklist use. Overall completion of the checklist sections was 97.26%. Comparison of 30-day morbidity demonstrated a statistically significant (p = 0.000) reduction in overall adverse event rates from 23.60% for historical control cases and 15.90% in cases with only team training, to 8.20% in cases with checklist use. CONCLUSIONS: Use of a comprehensive surgical safety checklist and implementation of a structured team training curriculum produced a statistically significant decrease in 30-day morbidity. Adoption of a comprehensive checklist is feasible with team training intervention and can produce measurable improvements in patient outcomes.

Information technologies and patient safety.

Advances in health information technology provide significant opportunities for improvements in surgical patient safety. The adoption and use of electronic health records can enhance communication along the surgical spectrum of care. Bar coding and radiofrequency identification technology are strategies to prevent retained surgical sponges and for tracking the operating room supply chain. Computerized intraoperative monitoring systems can improve the performance of the operating room team. Automated data registries collect patient information to be analyzed and used for surgical quality improvement.

Routine cholecystectomy is not mandatory during morbid obesity surgery.

BACKGROUND: Controversy exists concerning the utility of routine cholecystectomy during bariatric surgery. We report our series of bariatric surgical procedures at our institution without concurrent cholecystectomy. METHODS: From October 2003 to August 2005, 621 morbidly obese patients underwent a weight loss operation. Preoperatively, each patient had undergone abdominal ultrasound (AUS) to evaluate for abnormal gallbladder findings. Patients with previous cholecystectomy were excluded. Symptomatic patients with AUS findings consistent with gallbladder disease underwent concomitant cholecystectomy and bariatric surgery. Asymptomatic patients, despite AUS findings, did not undergo cholecystectomy with their bariatric operation. A comparison between the preoperative AUS-positive and AUS-negative, asymptomatic patients after bariatric surgery was performed. RESULTS: Of the 621 patients who underwent bariatric surgery, 170 (27%) had undergone previous cholecystectomy and were excluded. Of the remaining 451 patients, 17 with positive AUS findings and symptoms underwent cholecystectomy during bariatric surgery. The range of follow-up was 4-25 months. Of the 451 patients, 324 were asymptomatic and had negative AUS findings and 102 were asymptomatic and had positive AUS findings for gallbladder abnormalities. Postoperatively, 29 asymptomatic/AUS-negative patients (9%) developed symptoms and had positive AUS findings. Nine asymptomatic patients with AUS positive findings (9%) developed symptoms. Finally, 38 patients (8.4%) went on to undergo elective cholecystectomy. These 2 groups were not signficantly different statistically. CONCLUSIONS: In this study, the development of symptomatic/AUS-positive gallbladder abnormalities was low after obesity surgery, suggesting that mandatory cholecystectomy is not required at bariatric surgery.

Preventing port site inversion in laparoscopic adjustable gastric banding.

OBJECTIVES: Laparoscopic adjustable gastric banding (LAGB) is a safe, controlled method for weight loss in the morbidly obese patient. Inversion or dislodgement of the port leads to difficulty with access for band adjustments and frequently requires reoperation. We report our experience with port fixation to the rectus sheath of the abdominal wall by using port/mesh fixation to prevent port site complications. METHODS: One hundred and ninety-one morbidly obese patients underwent LAGB between April 2002 and August 2005. The first group had ports fixed to the rectus fascia of the abdominal wall with a standard 4-point suture technique. The second group had ports sutured to a mesh, which was then tacked to the rectus sheath of the abdominal wall. Port site complications were analyzed over a 5-month to 40-month period and compared between the 2 groups. Intraoperative port fixation times were recorded for each technique. RESULTS: Thirty-nine patients in the suture fixation group encountered a 20.5% port site complication rate, with 10.3% of the ports becoming dislodged or inverted. The mesh/tack group consisted of 151 patients. The port site complication rate was 5.3%, with only a 1.3% rate of port dislodgement or inversion. The port dislodgement or inversion rates were significantly different between groups (P = .0049). The average operative times for port insertion were 12 minutes for the sutured technique and 5 minutes for the mesh/tack technique. CONCLUSIONS: The mesh/tack method of port fixation reduced the incidence of dislodgement and rotation in our patient population, which resulted in greater ease of access for adjustments. Furthermore, the mesh/tack technique is a quick, safe approach for port fixation through a small incision.

Lymphoseek: a molecular imaging agent for melanoma sentinel lymph node mapping.

BACKGROUND: Lymphoseek is a molecular imaging agent specifically designed for sentinel lymph node mapping. We conducted a phase I clinical trial in which Lymphoseek was compared with filtered [(99m)Tc]sulfur colloid (fTcSC) for melanoma sentinel lymph node detection. METHODS: Twenty-four patients (33-81 years) with melanoma participated in this study. Four groups of six patients received an intradermal administration (.5 mCi) of 1.0, 5.0, or 10.0 nmol of (99m)Tc-labeled Lymphoseek or filtered [(99m)Tc]sulfur colloid. The injection site clearance was monitored by nuclear imaging for 3 hours. Lymph nodes obtained by gamma-guided biopsy (4.0-8.7 hours after injection) were assayed for radioactivity. Clinical chemistry values were monitored (before injection, before surgery, and 4 and 24 hours), and whole-body scans were acquired at 1 and 12 hours after injection. RESULTS: Lymphoseek exhibited a significantly (P < .001) faster injection site clearance at all dose levels. The mean Lymphoseek clearance half-time was 2.17 +/- .96 hours (n = 18) compared with 14.7 +/- 6.3 hours for fTcSC (n = 6). The mean sentinel lymph node uptakes of Lymphoseek (.73% +/- .94%) and fTcSC (.85% +/- 1.19%) were statistically equivalent (P = .68). Lymphoseek exhibited a lower mean number of sentinel lymph nodes per basin (1.6) than fTcSC (1.9). No adverse events were observed, nor were any clinically significant alterations in laboratory parameters. Radiation absorbed doses were lower than filtered [(99m)Tc]sulfur colloid. CONCLUSIONS: The molecular imaging agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with filtered [(99m)Tc]sulfur colloid.

Minimally invasive sentinel lymph node mapping of the pig colon with Lymphoseek.

BACKGROUND: Minimally invasive surgery and sentinel node mapping are being utilized increasingly in colon cancer surgery. Making these techniques efficient and easy to perform will be essential for the future of this and other gastrointestinal operations. The purpose of this study was to test a new laparoscopic gamma detection probe for minimally invasive sentinel node mapping of the colon, while utilizing Lymphoseek, a radiopharmaceutical specifically designed for sentinel lymph node (SLN) detection. METHODS: Eight anesthetized pigs received an endoscopic co-injection of Lymphoseek and Isosulfan Blue in the colon. The laparoscopic gamma detector, inserted via a 12-mm trocar, was used to identify radioactive sentinel lymph nodes. The reliability of the side-viewing probe was tested using a radioactive source. All blue and radioactive lymph nodes were excised and the signal-to-background ratio (S/B) and percent of injected dose (%ID) were measured. RESULTS: The probe was easy to maneuver and led to efficient visualization of the radioactive node. The side port allowed for better distinction between injection site scatter and sentinel node activity. The reliability of the probe was validated by an identification rate of 97%. At least one SLN was detected for each pig; two SLNs were detected in two pigs. All SLNs were stained blue. The SLN S/B ranged from 38 to 315 and the %ID ranged from 0.06% to 2.01%. Sentinel nodes were found within 10 minutes. CONCLUSIONS: Minimally invasive sentinel node mapping with the radiopharmaceutical Lymphoseek and a side-viewing gamma detector yielded high S/B and directionality for accurate mapping of gastrointestinal sentinel lymph nodes within minutes of radiotracer administration.

Sentinel lymph node mapping of the colon and stomach using lymphoseek in a pig model.

BACKGROUND: Lymphoseek is a radiopharmaceutical designed for sentinel lymph node (SLN) mapping. The purpose of this study was to compare Lymphoseek colon and gastric pharmacokinetics with filtered [(99m)Tc]sulfur colloid (fTcSC). METHODS: Eight anesthetized pigs received an endoscopic injection of Lymphoseek or fTcSC in the stomach and colon. Scintigraphy was obtained of both administration sites at 15-minute intervals up to 3 hours after injection, after which all SLNs were identified by a handheld gamma probe through a laparotomy incision. Isosulfan blue was administered at the injection site 5 minutes before SLN mapping. The percentage of injected dose (%ID) was measured for all harvested nodes, and the clearance half-life (T(c)) was calculated for all injection sites. RESULTS: The mean Lymphoseek clearance for colon (T(c), 2.56 +/- 1.04 hours) and gastric (T(c), 3.83 +/- 1.18 hours) injection sites was statistically faster (P =.030) compared with fTcSC (colon T(c), 14.98 +/- 3.41 hours; stomach T(c), 14.52 +/- 4.08 hours). After 3 hours, Lymphoseek exhibited a mean SLN %ID of 1.32% +/- 1.71% in the colon and 2.04% +/- 2.12% in the stomach; this was not statistically different from fTcSC (colon,.63% +/-.39%; stomach, 2.35% +/- 2.90%). SLN uptake of Lymphoseek was significantly different from second-echelon node %ID for the colon (P =.011) and gastric (P =.029) injection sites. All SLNs exceeded 10 times background, and there was no discordance between isosulfan blue and Lymphoseek or fTcSC. CONCLUSIONS: Three hours after colon stomach administration, Lymphoseek demonstrated rapid injection site clearance, detectable SLN uptake, and low second-echelon node uptake.

Dose-dependent biodistribution of [(99m)Tc]DTPA-mannosyl-dextran for breast cancer sentinel lymph node mapping.

[(99m)Tc]DTPA-mannosyl-dextran is a receptor-binding radiopharmaceutical specifically designed for sentinel lymph node mapping. The purpose of this study was to test the biodistribution and safety of [(99m)Tc]DTPA-mannosyl-Dextran at different molar doses. Twenty-four female breast cancer patients participated in this study. Four groups of 6 patients received an injection of 0.2, 1.0, or 5.0 nmol of [(99m)Tc]DTPA-mannosyl-Dextran or filtered [(99m)Tc]sulfur colloid. The injection site clearance was monitored by dynamic imaging for three hours. Whole body scans were acquired at 2.5 and 12, and lymph nodes were assayed for radioactivity after gamma-guided sentinel lymph node biopsy. Injection site clearance of [(99m)Tc]DTPA-mannosyl-Dextran was not statistically different in a dose-dependent manner. Dose-dependent sentinel node uptake was observed (p = 0.03). There were no clinically significant alterations in laboratory parameters among all dose levels at 4 h or 24 h post injection compared to preoperative levels. Radiation absorbed doses did not differ among the three dose levels, but were lower than filtered [(99m)Tc]sulfur colloid.