Vr Jacobs

Prospective clinical trial of SprayGel as a barrier to adhesion formation: an interim analysis.

STUDY OBJECTIVEnTo evaluate SprayGel, a new sprayable adhesion barrier developed for laparoscopic and open pelvic and abdominal surgical procedures.nnnDESIGNnProspective, randomized, controlled, multicenter trial (Canadian Task Force classification I).nnnSETTINGnUniversity clinic and private clinic.nnnPATIENTSnForty-five women, 24 randomized to treatment and 21 to control group.nnnINTERVENTIONSnOpen or laparoscopic myomectomy with and without application of SprayGel, followed by second-look laparoscopy (SLL) to evaluate postoperative adhesions.nnnMEASUREMENTS AND MAIN RESULTSnApplication of SprayGel was fast and easy. On average, 10 weeks after surgery, 18 treated patients (75%) and 13 (61.9%) controls had SLL. That procedure showed 5 (27.8%) of 18 treatment patients to be adhesion free versus 1 (7.7%) of 13 controls (p = 0.163). Patients randomized to SprayGel were 3.6 times more likely to be adhesion free than controls. Mean tenacity scores were significantly lower than in controls (0.5 vs. 1.7), a difference of 0.9 (95% CI 0.3, 1.5, p = 0.003) or 47% (95% CI 17%, 77%) less. Mean adhesion area was reduced in the treatment group (4.1 vs. 5.6) but not significant (p = 0.6747, 95% CI-5.4, 8.4). No adverse events regarding application of SprayGel were seen.nnnCONCLUSIONnSprayGel was effective in reducing postoperative adhesion severity, and showed a trend toward reducing frequency and extent of adhesions after laparoscopic and open myomectomy. Further studies are necessary to confirm the promising results of this interim analysis.

Laparoscopic Management of 641 Adnexal Tumors in Kiel, Germany

STUDY OBJECTIVEnTo evaluate the effectiveness and safety of laparoscopic and laparotomic management of ovarian tumors.nnnDESIGNnRetrospective analysis (Canadian Task Force classification II-2).nnnSETTINGnUniversity-affiliated hospital.nnnPATIENTSnSix hundred forty-one women with benign and malignant ovarian tumors.nnnINTERVENTIONSnLaparoscopy and laparotomy.nnnMEASUREMENTS AND MAIN RESULTSnBetween January 1997 and December 1998, 493 (76.9%) ovarian tumors were treated laparoscopically and 138 (21.5%) by laparotomy. Criteria for laparotomy were high suspicion of malignancy and tumors larger than 10 cm that were technically too difficult for the laparoscopic approach. The mean size of tumors treated laparoscopically was 4.5 cm (range 1.1-11 cm) and by laparotomy 8.2 cm (range 3-20 cm). Mean operating times were 75.7 minutes (range 30-200 min) and 126 minutes (range 30-235 min), respectively, and mean blood loss was 193 ml (range 50-1200 ml) and 431 ml (range 50-2500 ml), respectively. Twelve laparoscopies were converted to laparotomy, six because of technical reasons such as severe adhesions, bleeding, or tumor size, and six for intraoperative suspicion of malignancy. Of the latter, four (66.7%) turned out to be ovarian carcinoma and two (33.3%) borderline tumors. Histologic evaluation clearly revealed predominance of functional ovarian cysts, endometriomas, and dermoid cysts in the group treated by laparoscopy, whereas ovarian carcinomas, large endometriomas, and serous cysts prevailed in the laparotomy group.nnnCONCLUSIONnWith careful preoperative screening, the rate of laparoscopies for treatment of benign ovarian cysts can be increased. (J Am Assoc Gynecol Laparosc 8(1):74-82, 2001)

Measurement of CO2 hypothermia during laparoscopy and pelviscopy: How cold it gets and how to prevent it

STUDY OBJECTIVEnTo evaluate intraabdominal CO(2) temperature during a variety of standard operative laparoscopy procedures with different insufflators (BEI Medical, Snowden & Pencer, Storz Laparoflator, Storz Endoflator, Wolf) and devices to maintain body temperature (Bair Hugger, fluid warmer, Blanketrol blankets).nnnDESIGNnProspective, nonrandomized study (Canadian Task Force classification II-1).nnnSETTINGnCommunity hospital in rural Alabama.nnnPATIENTSnSixty-two consecutive patients (53 women, 9 men; average age 56.8 yrs, range 21-94 yrs).nnnINTERVENTIONSnPatients underwent standard laparoscopic and pelviscopic procedures during which intraoperative temperature changes in the insufflation system, abdomen, and rectum were measured.nnnMEASUREMENTS AND MAIN RESULTSnCarbon dioxide was at room temperature in the insufflation hose ( approximately 23 degrees C). During insufflation, intraabdominal gas temperature decreased to as much as 27.7 degrees C (average 32.7 degrees C) depending on length of operation (23 min-5 hrs 8 min), amount of gas used (12.8-801 L), gas flow (up to 20 L/min), and leakage rate. Preoperative and postoperative temperature comparisons showed no decline in rectal temperature (average +0.18 degrees C) because warming equipment was sufficient.nnnCONCLUSIONnThe decrease in intraoperative intraabdominal gas temperature is remarkable and can potentially harm the patient. It can be limited by restricting gas flow and leakage. In operations longer than 1 hour, substantial core body temperature drop should be prevented with appropriate heating and hydration devices. An insufflator with internal gas heating (Snowden & Pencer) had no significant clinical effect. (J Am Assoc Gynecol Laparosc 6(3):289-295, 1999)

Specific resistance of Veress needles, disposable and reusable trocars is limiting CO2 gas flow performance in pelviscopy and laparoscopy

SummaryAn efficient insufflation technique is essential for laparoscopy. Up to now physicians have had to rely on their experience and intuition when putting together an insufflation system. Comparable, objective data about the insufflation properties of all insufflation components used has not been available. In this study, details of the insufflation properties of disposable and reusable Veress needles and trocars and Luer lock connectors and the particular meaning of flow resistance for function and efficiency of the entire insufflation system have been measured and compared. In an independent laboratory study, a computer-based data acquisition measurement model was developed. Specific pressure dependent flow and resistance curves of insufflation components from manufacturers such as Auto Suture, Dexide, Ethicon, HiTec, Olympus, Origin, Richard-Allan, Volzer, Wiest, Wolf and Storz were evaluated by measurement of physical parameters pressure, CO2 gas flow and resistance. Through the introduction of ref...

Model to Determine Resistance and Leakage-Dependent Flow on Flow Performance of Laparoscopic Insufflators to Predict Gas Flow Rate of Cannulas

STUDY OBJECTIVEnTo characterize insufflator CO2 gas flow performance to predict gas flow rate with standard cannulas.nnnDESIGNnProspective, observational study (Canadian Task Force classification II-2).nnnSETTINGnLaboratory of university clinic.nnnPATIENTSnNone. Intervention. Gas flow (L/min) and average pressure (mm Hg) inside an abdomen model were measured at 12 mm Hg nominal pressure during steady state.nnnMEASUREMENTS AND MAIN RESULTSnAn abdomen box model for laboratory measurements was designed with different entrance and exit diameters simulated with hole disks from 0.5 to 7.6 mm. With a computer-based data-acquisition model, five insufflators (Olympus 9L and 16L, Storz 10L and 30L, HiTec 16L) were evaluated with 150 disk combinations. Flow performance in three-dimensional profiles showed different flow rates for all insufflators depending on resistance and leakage combination, maximum flow rate, and insufflation principle. Maximum flow was reached without resistance only in the insufflation system at high leakage rates. Low-pressure principle is more affected by resistance. Cannula flow rates at 12 mm Hg and 15 L/minute leakage ranged from 4.8 (Origin) to 6.0 L/minute (Storz HiCap) for Olympus 9-L insufflators and from 5.4 (Origin) to 15.10 L/minute (Storz HiCap) for Storz 30-L Thermoflator. Reusable cannulas have more flow efficacy than disposable ones, especially with high-flow insufflators, because of larger diameter at insufflation supply.nnnCONCLUSIONnGas flow depends not only on maximum flow of insufflators but also on resistance of cannulas and leakage rate. With this model it is possible to predict the real, available flow of insufflator-cannula combinations for the first time. Improved resistance of all components can save insufflation time.