SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Consensus Conference Statement on the General Use of Near-infrared Fluorescence Imaging and Indocyanine Green Guided Surgery: Results of a Modified Delphi Study.

BACKGROUND: In recent decades, the use of near-infrared light and fluorescence-guidance during open and laparoscopic surgery has exponentially expanded across various clinical settings. However, tremendous variability exists in how it is performed. OBJECTIVE: In this first published survey of international experts on fluorescence-guided surgery, we sought to identify areas of consensus and nonconsensus across 4 areas of practice: fundamentals; patient selection/preparation; technical aspects; and effectiveness and safety. METHODS: A Delphi survey was conducted among 19 international experts in fluorescence-guided surgery attending a 1-day consensus meeting in Frankfurt, Germany on September 8th, 2019. Using mobile phones, experts were asked to anonymously vote over 2 rounds of voting, with 70% and 80% set as a priori thresholds for consensus and vote robustness, respectively. RESULTS: Experts from 5 continents reached consensus on 41 of 44 statements, including strong consensus that near-infrared fluorescence-guided surgery is both effective and safe across a broad variety of clinical settings, including the localization of critical anatomical structures like vessels, detection of tumors and sentinel nodes, assessment of tissue perfusion and anastomotic leaks, delineation of segmented organs, and localization of parathyroid glands. Although the minimum and maximum safe effective dose of ICG were felt to be 1 to 2 mg and >10 mg, respectively, there was strong consensus that determining the optimum dose, concentration, route and timing of ICG administration should be an ongoing research focus. CONCLUSIONS: Although fluorescence imaging was almost unanimously perceived to be both effective and safe across a broad range of clinical settings, considerable further research remains necessary to optimize its use.

The use of tissue oxygen measurements compared to indocyanine green imaging for the assessment of intraoperative tissue viability of human bowel.

BACKGROUND: Adequate tissue oxygenation and perfusion remain fundamental to safe bowel resection surgery. Near infrared (NIR) imaging using indocyanine green has proven itself superior to clinical evaluation alone in assessing bowel perfusion, but requires expensive equipment not readily available in many centers. METHODS: We studied the IntraOx device (Vioptix Inc, Newark, CA USA), a handheld, tissue oxygen saturation assessment tool, to assess whether tissue bed oxygen saturation (StO2) is comparable to NIR assessment of bowel viability. Patients undergoing elective colon resection for benign and malignant disease were included. After choosing a clinical margin (CM) and dividing the mesentery, StO2 was measured at 5-cm intervals along the colon. A tissue oxygen saturation margin (TOM) was assigned where StO2 dropped off by at least 10 percentage points. NIR perfusion was then assessed to determine NIR margin (NIRM). Intraoperative and postoperative data were collected. RESULTS: 32 consecutive patients undergoing colectomies were analyzed. IntraOx sensitivity was 90.6%, specificity was 94.3%. The mean StO2 difference across the NIRM was 23.1%. In all but one case, the TOM matched the NIRM. In 3 cases, the TOM and NIRM concurred, but were a mean of 3.3 cm proximal to the CM and altered the surgical plan. At 4-week follow-up, no significant complications were reported. CONCLUSIONS: The IntraOx device consistently identified a margin of significant saturation "drop-off" which correlated with the findings on NIR perfusion and clinical assessment. These early data indicate that StO2 measurement may be equivalent to NIR assessment of bowel perfusion. In addition, the IntraOx device may be a more cost-effective solution for surgeons looking for adjunctive evaluation of bowel viability. More study is warranted in a larger group of patients to confirm these preliminary findings and to judge the impact of StO2 assessment on reducing anastomotic leaks.

A novel adaptor converts a laparoscope into a high-definition rigid sigmoidoscope.

The rigid sigmoidoscope is an important tool in a surgeon's armamentarium, yet it has remained essentially unchanged despite poor imaging and the inability to project or record the images. Herein we report our initial experience with a novel introducer built from readily available operating room supplies and designed to convert any standard laparoscope into a high-definition rigid sigmoidoscope.

Tissue Oximetry as a Potential Alternative to Indocyanine Green (ICG) Perfusion Assessment in Colorectal Anastomotic Cases.

INTRODUCTION: Anastomotic margin tissue perfusion is recognized as critical to successful colorectal anastomosis creation. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) is the most common modality used by surgeons as an adjunct to clinical assessment in confirming the adequacy of tissue perfusion. Tissue oxygenation as a surrogate for tissue perfusion has been described in a variety of surgical specialties but its use in colorectal surgery has been limited. Here, we report our experience using a handheld tissue-oxygen meter, IntraOx, for the evaluation of colorectal tissue bed oxygen saturation (StO 2 ) and compared its utility with NIR-ICG in identifying the viability of colonic tissue before anastomosis in a range of colorectal procedures. MATERIALS AND METHODS: This was an institutional review board-approved multicenter trial consisting of 100 patients undergoing elective colon resections. After specimen mobilization, a clinical margin was chosen based on the oncologic, anatomic, and clinical assessment as per the clinicians' standard technique. The IntraOx device was then used to take a baseline reading of colonic tissue oxygenation on a normal segment of perfused colon. Following this, measurements were taken circumferentially at 5 cm intervals along the bowel proximally and distally to the clinical margin. A StO 2 margin was then determined based on the point at which the StO 2 dropped off by ≥10 percentage points. This was then compared with the NIR-ICG margin using the Spy-Phi system. RESULTS: StO 2 was found to have a sensitivity and specificity of 94.8% and 93.1%, respectively, and a positive predictive value and negative predictive value of 93.5% and 94.5%, respectively when compared with NIR-ICG. At the 4-week follow-up, no significant complications or leaks were reported. CONCLUSIONS: The IntraOx handheld device was found to be similar to NIR-ICG in identifying a well-perfused margin of colonic tissue while having the added benefits of high portability and reduced costs. Further studies looking at the effect of the IntraOx on preventing colonic anastomotic complications such as leak and stricture are warranted.

Laparoscopic distal pancreatectomy.

BACKGROUND: Laparoscopic management of distal pancreatic malignancies has been slow to gain a foothold in all but high-volume tertiary referral centers. The aim of this study was to assess the safety and outcomes of laparoscopic distal pancreatectomy (LDP) performed in a low-volume community hospital by a diverse group of surgeons, none of whom have a specialized laparoscopic background. METHODS: We conducted a retrospective review of all patients who underwent open distal pancreatectomies (ODPs) and LDPs between August 2001 and June 2008. Data included type of surgery, open versus laparoscopy, demographics, operative time, blood loss, length of hospital stay, histopathologic diagnosis, postoperative complications, American Society of Anesthesiologists score, and mortality. RESULTS: Twenty-seven patients with pancreatic masses underwent distal pancreatic resection during the study period. Fifty-nine percent (n = 16) underwent LDP, and 41% (n = 11) underwent ODP. Mean patient age was 66 y (range, 40 to 86) for the LDP group and 62 (range, 40 to 84) for the ODP group. Mean operative time was 231 min (range, 195 to 305) for LDP and 240 (range, 150 to 210) for the ODP technique. Mean length of stay for LDP and ODP was 8 (range, 3 to 22) and 12 d (range, 5 to 2), respectively. Morbidity was 25% (n = 4) in the LDP group and 36% (n = 4) in the ODP group. None of the differences between the LDP and ODP groups were statistically significant. No mortalities occurred in either group. CONCLUSION: This study supports the idea that LDP can be safely and effectively performed by any surgeon comfortable with basic laparoscopy and may not require specialized training or a specialized center. Further data are required to make more definitive conclusions.

Management Options of Giant Colonic Lipomas.

Colonic lipomas are rare, benign neoplasms, typically asymptomatic, and predominantly found incidentally during autopsy or routine surveillance. Symptomatic lesions are usually those greater than 2 cm in diameter while "giant" lesions are characterized as those over 4 cm. Presentations can vary from asymptomatic to more severe sequelae, including obstruction, gastrointestinal bleeding, or intussusception. Resection of these lesions has historically been restricted to large or symptomatic lesions. However, recent reports suggest lipomas may retain the ability to grow and can become symptomatic over time despite being inconsequential initially. This series provides a review of the clinical manifestations of colonic lipomas, radiographic characteristics, and a treatment recommendation for management of these lesions using minimally invasive surgical techniques whilst advocating for consideration of resection prior to the development of symptoms or more emergent complications.

Intraoperative fluorescence imaging in different surgical fields: Consensus among 140 intercontinental experts.

BACKGROUND: Despite exponentially growing evidence supporting the use of intraoperative fluorescence imaging + indocyanine green dye, considerable variability exists in how and when it is used, and no published consensus guidelines exist. We have conducted Delphi surveys of international experts in the use of intraoperative fluorescence imaging covering 6 distinct surgical scenarios: laparoscopic cholecystectomy; colorectal, lymphedema, gastric cancer, and plastic surgery; and thyroid and parathyroid resections. Although each survey asked experts to vote on field-specific consensus statements, they also had 29 shared statements to permit some analysis spanning the 6 specialties. This article summarizes these results. METHODS: Data on the 29 shared statements from 6 two-round Delphi consensus surveys were compiled to identify areas of overall consensus and compare the different specialties. As with the individual surveys, consensus was defined as ≥70% intervoter agreement. RESULTS: Among 140 participating experts, overall consensus was achieved on 16 statements, including strong agreement that using indocyanine green is extremely safe, that it can be used even when informed written consent cannot be provided, that it significantly enhances anatomical visualization and impacts how procedures are performed, and that it significantly reduces overall procedural risk. However, indocyanine green dosing and timing are procedure-specific, with considerable variability persisting for some applications, and the overall consensus is that further research is necessary to optimize this facet of intraoperative fluorescence imaging. CONCLUSION: Fluorescence imaging is gaining traction across multiple surgical specialties as an invaluable intraoperative tool. Its use in clinical practice and research seems destined to increase.

Use of fluorescence imaging and indocyanine green during laparoscopic cholecystectomy: Results of an international Delphi survey.

BACKGROUND: Published empirical data have increasingly suggested that using near-infrared fluorescence cholangiography during laparoscopic cholecystectomy markedly increases biliary anatomy visualization. The technology is rapidly evolving, and different equipment and doses may be used. We aimed to identify areas of consensus and nonconsensus in the use of incisionless near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. METHODS: A 2-round Delphi survey was conducted among 28 international experts in minimally invasive surgery and near-infrared fluorescent cholangiography in 2020, during which respondents voted on 62 statements on patient preparation and contraindications (n = 12); on indocyanine green administration (n = 14); on potential advantages and uses of near-infrared fluorescent cholangiography (n = 18); comparing near-infrared fluorescent cholangiography with intraoperative x-ray cholangiography (n = 7); and on potential disadvantages of and required training for near-infrared fluorescent cholangiography (n = 11). RESULTS: Expert consensus strongly supports near-infrared fluorescent cholangiography superiority over white light for the visualization of biliary structures and reduction of laparoscopic cholecystectomy risks. It also offers other advantages like enhancing anatomic visualization in obese patients and those with moderate to severe inflammation. Regarding indocyanine green administration, consensus was reached that dosing should be on a milligrams/kilogram basis, rather than as an absolute dose, and that doses >0.05 mg/kg are necessary. Although there is no consensus on the optimum preoperative timing of indocyanine green injections, the majority of participants consider it important to administer indocyanine green at least 45 minutes before the procedure to decrease the light intensity of the liver. CONCLUSION: Near-infrared fluorescent cholangiography experts strongly agree on its effectiveness and safety during laparoscopic cholecystectomy and that it should be used routinely, but further research is necessary to establish optimum timing and doses for indocyanine green.

Use of fluorescence imaging and indocyanine green for sentinel node mapping during gastric cancer surgery: Results of an intercontinental Delphi survey.

BACKGROUND: Understanding the extent of tumor spread to local lymph nodes is critical to managing early-stage gastric cancer. Recently, fluorescence imaging with indocyanine green has been used to identify and characterize sentinel lymph nodes during gastric cancer surgery, but no published guidelines exist. We sought to identify areas of consensus among international experts in the use of fluorescence imaging with indocyanine green for mapping sentinel lymph nodes during gastric-cancer surgery. METHODS: In this 2-round, online Delphi survey, 27 international experts voted on 79 statements pertaining to patient preparation and contraindications to fluorescence imaging with indocyanine green during gastric cancer surgery; indications; technical aspects; advantages/disadvantages and limitations; and training and research. Methodological steps were adopted during survey design to minimize bias. RESULTS: Consensus was reached on 61 of 79 statements, including giving single injections of indocyanine green into each of the 4 quadrants peritumorally, administering indocyanine green on the same day as surgery, injecting a total of 1 to 5 mL of 5 mg/mL indocyanine green, injecting endoscopically into submucosa, and repeating indocyanine green injections a second time if sentinel lymph node visualization remains inadequate. Consensus also was reached that fluorescence imaging with indocyanine green is an acceptable single-agent modality for sentinel lymph node identification and that the sentinel lymph node basin method is preferred. However, sentinel lymph node dissection should be limited to T1 gastric cancer and tumors ≤4 cm in diameter, and further research is necessary to optimize the technique and render fluorescence-guided sentinel lymph nodes dissection acceptable for routine clinical use. CONCLUSION: Although considerable consensus was achieved, further research is necessary before this technology should be used in routine practice.

Use of fluorescence imaging and indocyanine green during colorectal surgery: Results of an intercontinental Delphi survey.

BACKGROUND: Fluorescence imaging with indocyanine green is increasingly being used in colorectal surgery to assess anastomotic perfusion, and to detect sentinel lymph nodes. METHODS: In this 2-round, online, Delphi survey, 35 international experts were asked to vote on 69 statements pertaining to patient preparation and contraindications to fluorescence imaging during colorectal surgery, indications, technical aspects, potential advantages/disadvantages, and effectiveness versus limitations, and training and research. Methodological steps were adopted during survey design to minimize risk of bias. RESULTS: More than 70% consensus was reached on 60 of 69 statements, including moderate-strong consensus regarding fluorescence imaging's value assessing anastomotic perfusion and leak risk, but not on its value mapping sentinel nodes. Similarly, although consensus was reached regarding most technical aspects of its use assessing anastomoses, little consensus was achieved for lymph-node assessments. Evaluating anastomoses, experts agreed that the optimum total indocyanine green dose and timing are 5 to 10 mg and 30 to 60 seconds pre-evaluation, indocyanine green should be dosed milligram/kilogram, lines should be flushed with saline, and indocyanine green can be readministered if bright perfusion is not achieved, although how long surgeons should wait remains unknown. The only consensus achieved for lymph-node assessments was that 2 to 4 injection points are needed. Ninety-six percent and 100% consensus were reached that fluorescence imaging will increase in practice and research over the next decade, respectively. CONCLUSION: Although further research remains necessary, fluorescence imaging appears to have value assessing anastomotic perfusion, but its value for lymph-node mapping remains questionable.

Fluorescence-guided surgery of the esophagus.

The use of indocyanine green (ICG) fluorescence near-infrared (NIR) imaging during gastrointestinal surgery has surged in recent years. Its use in esophageal surgery is actively being studied both in the clinical setting and in the lab. NIR imaging has several important applications in esophageal surgery including assessing perfusion of the gastrointestinal-esophageal anastomosis, lymphatic drainage and tracheal blood flow after mediastinal dissection. This is a review of the modern literature summarizing the current knowledge on fluorescence-guided surgery of the esophagus.

Evaluation of a modified circular stapler for use as a viscerotomy formation and closure device in natural orifice surgery.

BACKGROUND: The most challenging of the many hurdles surgeons must overcome to perform natural orifice translumenal endoscopic surgery (NOTES) safely is viscerotomy closure. The perfect device must be easy to deploy, suitable for use on any viscera, and able to create a rapid, reliable, and durable closure. The authors developed a novel device based on an existing circular stapler platform to create and then subsequently close a viscerotomy. The device was tested initially on an ex vivo porcine stomach model, then used on a survival canine model to confirm adequacy of gastric closure and rapidity of deployment. METHODS: Three study arms, each containing five stomachs, were used. For the experimental arm, a Surgassist (PMI, Langhorne, PA, USA) powered circular stapler (EEA) modified with an auger tip and premounted endoloops was used. This novel device was compared with two gold standard closure techniques: hand-sewn two-layer closure and linear stapled closure. Each stomach then was inflated slowly with dye, and the pressure at which each closure leaked was recorded. For evaluation of the closure's durability and ease of use, five mongrel dogs undergoing transgastric intraabdominal surgery had their gastrotomy formed and closed using the modified Surgassist stapler. Each animal was survived 14 days, then killed, after which a necropsy was performed. RESULTS: In the ex vivo model, the modified PMI EEA consistently achieved burst pressures exceeding 260 mmHg, which was statistically significant compared with either the hand-sewn closure or the linear stapled closure. In the survival group, all the animals survived for the 2-week study period without signs of sepsis. At necropsy, the closures were found to be intact. CONCLUSION: The prototype transvisceral purse-string device consistently produced a tight, safe, and reliable closure. It can be deployed and cinch-closed rapidly. This study suggests that this new device may be a promising option for use in NOTES.

Transitioning to single-incision laparoscopic inguinal herniorrhaphy.

BACKGROUND: Laparoendoscopic single-site surgery (LESS) offers cosmetic benefits and may represent further progress towards reducing the invasiveness of surgical interventions. We report our initial experience with LESS totally extraperitoneal (TEP) inguinal herniorrhaphy. MATERIALS AND METHODS: Beginning March 2009, we transitioned from a multiport laparoscopic TEP (MLH) technique to a single-incision TEP (SITE) technique. The first 52 consecutive patients who underwent SITE at our institution were compared with the preceding 52 MLH repairs. RESULTS: Of the first 52 patients undergoing SITE, there were no conversions to either open or multiport surgery. The mean operative time for the SITE cases did not differ significantly from that of MLH. Complications were equivalent between the 2 groups and included postoperative seroma and urinary retention. CONCLUSIONS: Transitioning from MLH to SITE was readily accomplished without significantly altering operative time or morbidity.

Novel assessment of intestinal anastomotic perfusion using ICG SPY in a continuous flow LVAD patient.

HeartMate II left ventricular assist device (LVAD) assists heart failure patients by generating continuous flow via axial flow pump placed in the left ventricle. Little is known of the effect of continuous flow on intestinal anastomoses. This is the first case visually documenting altered perfusion patterns in patients with LVADs using indocyanine green (ICG). A 72-year-old male required a colon resection, for adenocarcinoma, following implantation of an LVAD. Perfusion of the anastomosis was evaluated using indocyanine. During the assessment, an unusual perfusion pattern was noticed. Normally, flow as measured by SPY is seen as an initial blush of contrast followed by a gradual, pulsatile increase in the progression of the indocyanine through the tissues. In this patient, instead of the usual initial blush, a continuous beam of ICG was seen to flow though the blood vessels. This novel perfusion pattern is consistent with flow generated from LVAD.

The Use of Fluorescence Imaging in Colon Interposition for Esophageal Replacement: A Technical Note.

Every field of surgery has seen an explosion of new technologies aimed at improving surgical technique and reducing complications. The use of near-infrared (NIR) fluorescence to assess perfusion has been described in several surgical disciplines. NIR provides the surgeon with real-time perfusion assessment of a target organ or anastomosis and can be invaluable in aiding decision-making during the index operation. In the following article we discuss the use of fluorescence-guided perfusion assessment during colonic interposition for esophageal replacement. To our knowledge this is the first description of the use of fluorescence-guided perfusion assessment during colonic interposition.

Feasibility study of natural orifice transluminal endoscopic surgery inguinal hernia repair.

BACKGROUND: A potentially less-invasive technique, transluminal surgery, may reduce or eliminate pain and decrease time to full return of activities after abdominal operations. Inguinal hernia repair is perfectly suited to the transgastric endoscopic approach and has not been previously reported. OBJECTIVE: Our purpose was to evaluate the feasibility of transgastric bilateral inguinal herniorrhaphy (BIH). DESIGN: Feasibility study with a nonsurvival canine model. INTERVENTIONS: Under general anesthesia, male mongrel dogs weighing 20 to 30 kg had a dual-channel endoscope introduced into the peritoneal cavity over a percutaneously placed guidewire. An overtube with an insufflation channel was used. Peritoneoscopy was performed, and bilateral deep and superficial inguinal rings were identified. The endoscope was removed, premounted with a 4 x 6 cm acellular human dermal implant and then readvanced intraperitoneally through the overtube. The implant was then deployed across the entire myopectineal orifice and draped over the cord structures. Bioglue was then applied endoscopically, and the implant was attached to the peritoneum. After completion of bilateral repairs, the animals were killed and necropsy performed. RESULTS: Five dogs underwent pure natural orifice transluminal endoscopic surgery (NOTES) intraperitoneal onlay mesh (IPOM) BIH. Accurate placement and adequate myopectineal coverage was accomplished in all subjects. At necropsy no injuries to the major structures were noted but Bioglue misapplication with contamination of unintended sites did occur. LIMITATIONS: Our study involved only a small number of subjects in nonsurvival experiments, and no gastric closure was used. CONCLUSIONS: Many of the characteristics of inguinal hernia repair are especially well suited to the transgastric approach. The repair is in line with the transgastric endoscope vector, bilateral defects are adjacent, and the IPOM technique does not require significant manipulation or novel instrumentation.

Continuous infusion of intraperitoneal bupivacaine after laparoscopic surgery: a randomized controlled trial.

BACKGROUND: A standard approach for postoperative analgesia in laparoscopic surgery is to infiltrate the incisions with local anesthetic in combination with systemic opioids. The intraperitoneal introduction of local anesthetic in this setting has the potential to provide appropriate analgesia without the side effects of systemic opioids. We performed a randomized clinical trial of the On-Q pump delivery system to determine the safety and efficacy of this device for this novel purpose. METHODS: Thirty patients undergoing laparoscopic adjustable gastric banding were randomly assigned to one of two groups. The treatment group received On-Q pump systems filled with 0.375% bupivacaine, while the control group received pumps filled with 0.9% normal saline. The pump's catheter was introduced intraperitoneally, and bupivacaine or saline was then delivered for the first 48 h after surgery. Patient's subjective pain scores were evaluated at preset intervals. In addition, shoulder pain, morphine requirements, and anti-emetic requirements were tabulated. RESULTS: A statistically significant decrease in patient's subjective reports of pain by visual analog score was noted in the On-Q group 1.8+/-1.93 vs. control 3.5+/-2.4, p<0.046 and remained significant until the end of the study (48 h). No statistical difference was noted in shoulder pain, morphine requirements, or anti-emetic requirements at any time point. CONCLUSION: Our trial was able to provide evidence of significant reduction in postoperative pain as measured by subjective pain scores with the use of continuous intraperitoneal bupivacaine using the On-Q pain pump system. Further investigation is warranted to evaluate the cost effectiveness of this technique.