Comparison of the Safety and Efficacy of Valveless and Standard Insufflation During Robotic Partial Nephrectomy: A Prospective, Randomized, Multi-institutional Trial.

OBJECTIVE: To use a randomized, prospective, multi-institutional study to compare the safety and efficacy of conventional insufflation (CIS) and valveless insufflation (AirSeal Insufflation - AIS) at the conventional pressure of 15 mm Hg in robot-assisted partial nephrectomy - a surgery where AIS has gained popularity for maintaining visualization despite suction. This study was also powered to evaluate the effect of decreasing pneumoperitoneum by 20% in the valveless system. MATERIALS AND METHODS: Three high-volume institutions randomized subjects into CIS 15, AIS 15, and AIS 12 mm Hg cohorts. Endpoints included rates of subcutaneous emphysema (SCE), pneumothorax (PTX), pneumomediastinum (PMS), intraoperative end-tidal carbon dioxide (ET CO2), and peak airway pressure (PAP), as well as hospital stay, post-operative pain, and complications. Given the substantial proportion of retroperitoneal surgery, a secondary analysis evaluated the effect of surgical approach. RESULTS: Two hundred and two patients were accrued. SCE was decreased in the AIS 12 mm Hg group (p=0.003). PTX and PMS rates were not statistically significantly different across the 3 insufflation groups. Higher rates of SCE and PMS, although not PTX, were noted in all retroperitoneal surgery groups - with lower SCE rates for AIS 12 mm Hg regardless of surgical approach. CONCLUSION: AIS is often preferred for complex procedures including retroperitoneal and transperitoneal robotic-assisted partial nephrectomy, for its maintenance of pneumoperitoneum despite continuous suction necessary for visualization. This study shows that AIS is safe when compared to CIS at 15 mm Hg, and shows improvement in outcomes when pneumoperitoneum pressure is reduced by 20% to 12 mmHg.

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

PURPOSE: To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures. METHODS: Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO2 required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis. RESULTS: Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO2 used, number of attempts for successful entry, and major/minor complications (p > 0.05). CONCLUSIONS: Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation. CLINICAL TRIAL REGISTRATION: PACTR201510000999192.

Veress Needle Creation of a Pneumoperitoneum: Is It Risky? Results of the First Belgian Group for Endoscopic Surgery-Snapshot Study.

Background: Every laparoscopic procedure starts with the creation of a pneumoperitoneum. The open trocar introduction and the use of a Veress needle (VN) are the two most frequent techniques used. The aim of this study was to evaluate safety of the techniques used to create pneumoperitoneum in laparoscopic abdominal surgery by Belgian minimally invasive surgeons. Materials and Methods: This is a prospective study including all consecutive patients undergoing a laparoscopic surgical procedure for a 2-month period. Primary endpoint was access-related problems during creation of a pneumoperitoneum. Access-related problems were registered using a special smartphone application, facilitating data recording and patient registration. Results: Overall, 9 out of 212 invited surgeons (4.2%) actively registered patients during the study period. A total number of 342 patients were included with 6 access-related problems (1.8%) and conversion to open surgery was necessary in 16 patients (4.7%). Most reported access-related problem was failure to establish a pneumoperitoneum secondary to insufflation of the omentum. There were no major access-related complications. There was no conversion in the group of patients who had an access-related problem. Conclusion: VN entry to create a pneumoperitoneum is safe. In a short study period, gathering data by surgeons willing to participate in a snapshot study is easy and facilitated by a web-based application.

Underreporting of Veress Needle Injuries: Comparing Direct Observation and Chart Review Methods.

BACKGROUND: Adverse events in surgery occur frequently, increase likelihood of postoperative morbidity, and mostly take place in the operating rooms. Several surgeons have advocated for learning from adverse events and near misses to help improve patient safety. To do so, one must first understand how to accurately identify and report intraoperative events. MATERIALS AND METHODS: Consecutive laparoscopic cases performed in a referral center were included in the cohort. Veress needle (VN) injuries were characterized according to a priori established criteria. Two methods were used to identify VN injuries: direct observation and patient chart review. For direct observation, trained surgeon assessors identified the outcomes using a comprehensive data capture platform called the operating room black box. On the other hand, operative reports and patient charts were reviewed by trained assessors to identify reported VN injuries. RESULTS: Hundred thirty-one cases were analyzed. There were 12 (9%) VN injuries identified by direct observation compared to 3 (2%) identified in patient chart review method. Injuries to the liver and stomach were identified by both methods, whereas injuries to the omentum were not reported in patient charts even if they required rectification. There were seven VN injuries that required rectification, lasting up to 12% of the operating time. There were 47 (35%) near misses identified through direct observation, whereas none was reported in patient charts. CONCLUSIONS: Direct observation enables characterization of VN injury and near misses with far greater detail and accuracy than patient chart review.

OneShot-M: A New Device for Close Laparoscopy Pneumoperitoneum.

INTRODUCTION: The induction of pneumoperitoneum is the first and most critical phase of laparoscopy, due to the significant risk of serious vascular and visceral complications. The closed technique for the creation of pneumoperitoneum could lead to several surgical complications. The present study aimed to overcome the complications associated with the insertion of Veress needle, improving its use, and facilitating the rapid creation of pneumoperitoneum. METHODS: Thirty large white female pigs were enrolled in our study. A common plunger was modified in order to allow the passage of a 15-cm long Veress needle. This method was applied to 26 laparoscopic procedures (26 pigs) of several specialist branches. RESULTS: OneShot-M close laparoscopy pneumoperitoneum creation device allowed us to obtain pneumoperitoneum quickly in all attempts, without any intraoperative and postoperative complications related to the use of the Veress needle. CONCLUSION: The use of the proposed device showed an induction time as quick as the standard laparoscopic closed abdominal entry. The patented device is cheap and allows a safe abdominal entry. In addition, abdominal entry is much faster than the classic open technique.

The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum.

Low-impact laparoscopic (LIL) cholecystectomy is an innovative surgical protocol that combines the use of mini-laparoscopic instruments (3-mm ports) under a low- and stable-pressure pneumoperitoneum (8 mmHg), with the aim of minimizing the surgical invasiveness and the risks related to CO2 insufflation on the peritoneal environment. In day-surgery settings, LIL may contribute to increase the surgical success due to several potential benefits in terms of postoperative pain intensity and time to full recovery. In 14 consecutive patients requiring cholecystectomy for uncomplicated cholelithiasis, LIL was carried out uneventfully. No conversion, intra-operative or postoperative complications occurred. All patients were discharged the same day of surgery. Postoperative pain was well tolerated with no need of prolonged opioid therapy. Technical aspects and indications for LIL cholecystectomy are detailed.

The Effect of Sterilization Methods of Endoscopic Instruments on the Body: A Study on Rat Model.

PURPOSE: Laparoscopy is widely used in many surgical areas for diagnosis and treatment. The need for sterilization of reusable instruments is an important issue. Ensuring patient safety, preventing infection, and protecting the functionality of the instruments are the most important points to be considered. We aimed to investigate two sterilization methods and their effects generated by their distribution into intra-abdominal tissues during insufflation. MATERIALS AND METHODS: 21 rats were used in the study. The Control Group (Group 1) received anesthesia for 1 hour; Group 2 (Glutaraldehyde (GA)-Pneumoperitoneum Group) received anesthesia for 1 hour; Group 3 (Ethylene Oxide (EO)-Pneumoperitoneum Group) received anesthesia for 1 hour. After 24 hours, the animals were sacrificed, and the kidneys and omentum of the animals were analyzed in a histopathological manner. Blood samples were analyzed at preoperative 24th hour and at postoperative 24th hour. RESULTS: There was a statistically significant difference in omentum, endothelium, and glomerular scores between the groups (p < 0.001 for all groups). Endothelial and glomerular scores were different at a statistically significant level in the EO and GA groups compared to the Control Group. The total score was higher at a statistically significant level in the EO and GA groups compared to the Control Group (p < 0.001 for both groups). CONCLUSION: It was determined in our study that sterilization methods such as EO and GA cause damage in intra-abdominal tissues. In the light of these results, we consider that the most ideal laparoscopic surgery set is the single-use laparoscopy set. However, this does not seem possible especially in developing countries in practice.

Latif's point: A new point for Veress needle insertion for pneumoperitoneum in difficult laparoscopy.

INTRODUCTION: Creating pneumoperitoneum is the most challenging step during laparoscopy. The periumbilical area is the classic site for Veress needle insertion. We adopted a new access point for peritoneal insufflation. METHODS: We introduced a new point for Veress needle insertion to create pneumoperitoneum during difficult laparoscopic procedures. The needle is placed between the xiphoid process and the right costal margin, and it then proceeds toward the patient's right axilla. We collected data to compare using this new method of peritoneal insufflation with using Palmer's point for pneumoperitoneum. RESULTS: Since 2013, we have used this new technique in 570 patients (first group) and Palmer's point in 459 patients (second group). Among these patients, 196 patients (20%) had had previous abdominal operations, 98 patients (10%) had irreducible ventral hernia, and 735 patients (70%) were morbidly obese. The two groups were comparable in terms of patient characteristics. The mean time to create pneumoperitoneum in the first group was 0.8 ± 0.002 min compared to 1.08 ± 0.007 min in the second group (P ≤ 0.5). The mean number of punctures was 1.57 ± 1.02 in the first group compared to 2.9 ± 1.5 in the second group (P≤ 0.5); in the first group, 97% were successful on the first attempt entry, whereas this figure was 91% in second group. In the first group, the liver was punctured in 13 patients without any further complications; no other viscera were punctured. In the second group, gastric puncture occurred in 5 cases, transverse colon in 2 cases, and omental injury in 12 cases. CONCLUSION: This new access point may represent a safe, fast, and easy way to create pneumoperitoneum, as well as a promising alternative to Palmer's point in patients who are not candidates for classic midline entry.

A Prospective, Randomized, Clinical Trial on the Effects of a Valveless Trocar on Respiratory Mechanics During Robotic Radical Cystectomy: A Pilot Study.

BACKGROUND: Prolonged pneumoperitoneum and Trendelenburg positioning for robot-assisted radical cystectomy (RARC) are essential for optimizing visualization of the operative field, although they worsen hemodynamic and respiratory function. Our hypothesis is that the use of a valveless trocar (VT) may improve respiratory mechanics. METHODS: In this prospective, 2-arm parallel trial, patients ASA II to III undergoing RARC were randomly assigned into 2 groups: in the VT group, the capnoperitoneum was maintained with a VT; in the control group, the capnoperitoneum was maintained with a standard trocar (ST group). Inspiratory plateau pressure (Pplat), static compliance (Cstat), minute volume (MV), tidal volume (Vt), and carbon dioxide (CO2) elimination rate were recorded at these times: 15 minutes after anesthesia induction (T0), 10 minutes (T1) and 60 minutes (T2) after first robot docking, 10 minutes before first undocking (T3), 10 minutes (T4) and 60 minutes (T5) after second docking, 10 minutes before second undocking (T6), and 10 minutes before extubation (T7). The primary end point of the study was the assessment of Pplat mean value from T1 to T6. RESULTS: A total of 56 patients were evaluated: 28 patients in the VT group and 28 in the ST group. VT group had lower Pplat (means and standard error, VT group 30 [0.66] versus ST group 34 [0.66] cm H2O, with estimated mean difference and 95% confidence interval, -4.1 [-5.9 to -2.2], P < .01), lower MV (means and standard error, VT group 8.2 [0.22] versus ST group 9.8 [0.21] L min, P < .01), lower CO2 elimination rate (means and standard error, VT group 4.2 [0.25] versus ST group 5.4 [0.24] mL kg min, P < .01), lower end-tidal CO2 (ETCO2) (means and standard error, VT group 28.8 [0.48] versus ST group 31.3 [0.46] mm Hg, P < .01), and higher Cstat (means and standard error, VT group 26 [0.9] versus ST group 22.1 [0.9] mL cm H2O, P < .01). Both groups had similar Vt (P = .24). CONCLUSIONS: During RARC, use of a VT was associated with a significantly lower Pplat and improvement in other respiratory parameters.

Use of Pneumoperitoneal Puncture for Peritoneal Catheter Placement in Lumboperitoneal Shunt Surgery: Technical Note.

BACKGROUND: In hydrocephalus shunt surgery, a peritoneal catheter is traditionally inserted with laparotomy incision. The abdominal incision length will not be shorter than 3 cm in most cases. A longer incision has to be made in obese patients. The lateral position in lumboperitoneal shunt (LPS) surgery also increases the difficulty of laparotomy. This report introduces a simple technique of pneumoperitoneal puncture for peritoneal catheter placement in LPS surgery. METHODS: Twenty-eight communicating hydrocephalus cases underwent pneumoperitoneal puncture in an LPS operation. Abdominal incision length, time for peritoneal catheter placement, and postoperative complications were recorded. RESULTS: The length of the abdominal incision was 1 cm, and the average time for peritoneal catheter placement was 3.5 minutes. No patient suffered from infection and obstruction. Two cases of subdural hematoma because of cerebrospinal fluid overdrainage occurred. CONCLUSIONS: The pneumoperitoneal puncture technique has proven, in our experience, to be a minimally invasive, simple, and reliable method in a peritoneal catheter placement procedure. This technique, which needs to be assessed further by larger case series, may be considered a new method of choice for peritoneal catheter placement in LPS surgery.

Comparison of Pneumoperitoneum Stability Between a Valveless Trocar System and Conventional Insufflation: A Prospective Randomized Trial.

OBJECTIVE: To compare the variation in pneumoperitoneum and physiologic effects of patients undergoing laparoscopic renal surgery using the valveless trocar insufflation system (VI) vs a conventional insufflation system (CI). METHODS AND MATERIALS: We conducted a single-center, randomized controlled trial in patients undergoing renal surgery at 15 mm Hg insufflation using a VI system vs a CI system. The primary outcome measured was variation in insufflation pressure, and end-tidal CO2 at 10 and 25 minutes. RESULTS: Fifty-six patients (VI n = 28 or CI n = 28) met inclusion criteria and were randomized. There was significantly less variability in pressure readings, as measured by coefficient of variation, during VI compared to CI (7.8% vs 15.6%, P < .001). There was significantly less time spent within the range with pressure readings ≥18 mm Hg (median 0.2% vs 16.5%, P < .001) and ≤12 mm Hg (median 1.7% vs 5.6%, P = .011) during VI compared to CI. Additionally, there was significantly less time spent with pressure readings in the "unacceptable" range of ≥20 mm Hg (median 0% vs 0.08%, P < .001) and ≤10 mm Hg (median 0.09% vs 2.6%, P < .001) during the cases with VI compared to CI. End-tidal CO2 was significantly lower at 10 minutes (P = .036) after insufflation in the valveless trocar group compared to the conventional treatment group. There were no other significant differences in physiologic metrics. CONCLUSION: Compared with a CI, the VI provides a significantly more stable pneumoperitoneum during laparoscopic renal surgery and lower end-tidal CO2 at 10 minutes.

[OPEN LAPAROSCOPY--A MODIFIED HASSON TECHNIQUE].

The open technique was first described by Hasson in 1970. This technique consists of creating a small umbilical incision under direct visualization to enter the abdominal cavity followed by the introduction of a blunt trocar. Pneumoperitoneum is then rapidly created. Hasson proposed its potential benefits to be the avoidance of blind insertion of the Veress needle and bladed trocar, prevention of visceral and vascular injuries, preperitoneal insufflation and gas embolism, guaranteed pneumoperitoneum, and a more anatomical repair of the abdominal wall. Since that time, many surgeons have made some modifications to first Hasson technique. Here we described the way we do the open laparoscopy in our hospital and different positive and useful details we put to original Hasson version.

A dual-valve system to minimize loss of pneumoperitoneum in laparoscopic surgery.

BACKGROUND AND OBJECTIVES: Loss of visualization of the surgical field due to pneumoperitoneum deflation when CO2 insufflator cylinders become empty can occur at key moments during laparoscopic surgery. The purpose of this study was to examine the incidence of intraoperative cylinder exhaustion in the United Kingdom, determine its impact on patient safety, and design and test a novel device to minimize the phenomenon. METHODS: We performed a national cross-sectional survey of U.K. surgeons, inviting all members of the Association of Surgeons of Great Britain and Ireland (ASGBI) and the Association of Upper GI Surgeons (AUGIS) to participate. We designed and tested a novel dual-valve system to allow rapid intraoperative exchange of CO2 cylinders. RESULTS: Eighty-five percent of the U.K. surgeons surveyed reported loss of surgical visualization at critical times during laparoscopic surgery, caused by the decrease in pneumoperitoneum during CO2 cylinder exchange. Eighty-four percent said that the process contributed to the surgeon's stress, and 63% said that a device that maintains uninterrupted pneumoperitoneum would reduce the risk of intraoperative complications. In our locale, a timed cylinder exchange was, on average, 30 times quicker with the novel dual valve than by conventional cylinder exchange (mean conventional exchange time, 61.3 ± 7.3 s vs. novel device, 2.0 ± 0.2 s; P ≤ .0001) and could be performed just as rapidly by staff unfamiliar with the device (2.2 ± 0.3 s vs. 1.9 ± 0.4 s P = .1945). We suggest that this simple, low-cost system could be developed for use in a clinical setting to enhance patient safety.