1514.pdf 861Vol. 10 | No. 2 | Spring 2013 |U R O LO G Y J O U R N A L 1Urology & Nephrology Research Center, Department of Urology, Hamadan University of Medical Sciences, Hamadan, Iran 2Department of General Surgery, Hamadan University of Medical Sciences, Hamadan, Iran 3Endometr & Endometriosis Research Center, Department of Gynecology, Hamadan University of Medical Sciences, Hamadan, Iran 4Department of Community Medi- cine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran 5Islamic Azad University, Tehran Medical Branch, Tehran, Iran Hamid Shayani-Nasab,1 Mohammad Ali Amir-Zargar,1 Seyed Habibollah Mousavi-Bahar,1 Abdolmajid Iloon Kashkouli,1 Manoochehr Ghorban-Poor,2 Marzieh Farimani,3 Saadat Torabian,4 Amir Ali Tavabi5 Complications of Entry Using Direct Trocar and/or Veress Needle Compared with Modified Open Approach Entry in Laparoscopy Six-Year Experience Corresponding Author: Abdolmajid Iloon Kashkouli, MD; MPH Urology & Nephrology Research Center, Beheshti Hospital, Eram Blvd, Hamadan, 6516757666, Iran Tel: +98 811 838 0704 Fax: +98 811 838 0098 E-mail: ilounmajid@yahoo.com Received June 2012 Accepted June 2013 Purpose: To compare the results obtained from three routine laparoscopic entry techniques, including Direct Trocar (DT), Veress Needle (VN), and Open Approach (OA). Materials and Methods: were evaluated prospectively in 453 consecutive patients who had undergone laparoscopy Results: Of 453 patients, 105 (23.2%) were operated on with the DT, 168 (37.1%) with the among the groups in terms of mean age (P = .003), male-to-female ratio (P < .001), indica- tions for the operation (P < .001), and mean trocar insertion time (P < .001). Three major complications (1 colon perforation and 2 iliac artery injuries) occurred in DT and one (iliac P = .04). Four major complications required laparotomy. Minor complications were seen in 6 (5.8%), 9 (5.4%), and 17 (9.4%) patients (P = .274) and gas leakage in 4 (3.8%), 16 (9.5%), and 27 (15%) patients (P Conclusion: Although DT and VN are rapid and relatively safe, they can be associated with - able due to less major complications. Keywords: laparoscopy, pneumoperitoneum, complications LAPAROSCOPIC UROLOGY 862 | INTRODUCTION Establishing an acceptable pneumoperitoneum is the best entry technique into the abdominal cavity is al- ways a dilemma, and may result in complications and severe morbidity.(1-3) Major vascular and bowel injuries are rare, but serious complications of laparoscopic surgery. Generally, the insertion technique is done with Direct Trocar (DT), which has the potential for injury.(4) Although Veress Needle (VN) is widely used as another popular technique, life-threatening complications.(4) The Open Approach (OA) is relatively more safe; hence, is a good alternative to DT and VN techniques, even if it is considered cumbersome by many surgeons. Although OA is credited with reducing the incidence of vas- cular and visceral complications to nil, a 0.2% incidence of complications among 10 840 open gynecologic laparosco- pies and a 0.06% incidence of bowel injuries have been re- ported.(5) Some surgeons use a new version of OA as Modi- (6,7) Furthermore, some surgeons use OA for percutaneous nephrolithotomy.(8) To compare and designed this prospective, nonrandomized, clinical study and discussed the results. MATERIALS AND METHODS This study was approved by Urology & Nephrology Re- search Center, Hamadan University of Medical Sciences as well as Chancellor of Research and Technology of Hamadan University of Medical Sciences, Hamadan, Iran. After ethic committee approval was obtained based on Declaration of Helsinki, this observational study was conducted prospec- tively at Shahid Beheshti, Ekbatan, Besat, and Fatemieh aca- - cal Sciences in Hamadan, Iran from January 2005 to January 2011.These hospitals are the main centers for laparoscopic surgery in Hamadan province with a population of more than 1 700 000 people in the west of Iran. During the period of six years, all patients with any age who had undergone laparoscopic surgery were enrolled in the study. The only criterion for the technique selection was the surgeon’s preference. Exclusion criteria were any contraindi- cation for laparoscopy, such as uncorrectable coagulopathy, massive hemoperitoneum or hemoretroperitoneum, gener- alized peritonitis, and suspected malignant ascites. Further- more, 34 patients were excluded from the study due to previ- ous abdominopelvic surgery, body mass index more than 40 kg/m2, and refusal of surgery. Finally, 453 patients were evaluated as: group 1, DT (n = entry technique (n = 180). Various surgeons with different specialty, who have been employees of Hamadan University of Medical Sciences with at least assistant professor degree, learning curve, performed the operations. After full pre-operative assessment, including history tak- ing, general physical examination, laboratory evaluation, and diagnostic studies, patients were admitted to the hospital on the day of the procedure or one day prior for some major operations. Data, such as gender, age, body weight, surgery indications, intra and postoperative complications, and mortality and morbidity rates, were compared among the groups. Compli- conversion to an open procedure or re-intervention (mesen- teric or iliac vessels, the bowel, or solid organ injury) and - encing the length of hospital stay (subcutaneous emphysema, injury). Statistical Analysis Data were analyzed by SPSS software (the Statistical Pack- age for the Social Sciences, Version 13.0, SPSS Inc, Chicago, Illinois, USA) and expressed as mean ± standard deviation. Independent t test was used for quantitative parameters and Chi-Square for others. A P value of less than .05 was consid- Surgical Procedure - Laparoscopic Urology 863Vol. 10 | No. 2 | Spring 2013 |U R O LO G Y J O U R N A L ing the patients in appropriate position, in group 1, a 12-mm incision was made just below the umbilicus. First, a 5-mm incision was made on the rectus muscle sheath. Then, a 10 to 12-mm disposable shielded trocar was passed vertically into the peritoneal cavity. Entry into the abdominal cavity was The obturator was removed, and carbon dioxide gas was in- of 12 to 14 mmHg. Subsequently, other trocars were inserted. (9) In the VN group, a pneumoperitoneum was created with dis- posable or metal VN (70 or 120 mm, 14 gauge, and 2 mm outer diameter). The VN was inserted through a created su- praumbilical incision in supine or lateral decubitus position. mm trocar was inserted in a similar manner to group 1.(8) midclavicular incision in obese patients, incision medial edge was held with a blunt homeostasis, and Metzen was used for dissection onto the fascia. After elevation of the abdominal cavity with the towel clips, followed by an under vision small incision by surgical blade, the fascia was dilated about 10 to peritoneal cavity was performed downwardly by closed Metzen and with empty bladder. Metzen was set back in open manner to prevent solid or hollow organ injury. After visual clips to prevent instability and probable gas leakage if need. (6,10) RESULTS Of 453 patients, 105 (23.2%) were operated on by DT, 168 are presented in Table. The main indications for the operation were urologic (renal cyst, undescended testes, inguinal hernia, and ureteral stone), appendicitis), and gynecologic diseases (diagnostic laparos- copy, tubal ligation, and infertility). No mortality was observed in each group. There were sta- tistical differences among the groups in terms of mean age (P = .003), male-to-female ratio (P < .001), indications for the operation (P < .001), and mean trocar insertion time (P < .001). Complications were not associated with the surgeons’ experi- ence. There were three major complications (1 colon perfo- ration and 2 iliac artery injuries) in group 1 and one (iliac artery injury) in group 2 whereas no major complication was detected in group 3 (P = .04). These four major complica- tions required a re-intervention, such as laparotomy. One pa- tient with iliac artery injury in the VN group improved after one-week intensive care unit admission. As Table shows, 32 minor complications occurred dur- ing insertion technique. These complications were seen in 6 (5.8%), 9 (5.4%), and 17 (9.4%) patients in the DT, VN, and OA groups, respectively (P = .274). There was no other for any unrecognized intra-abdominal injury. Gas leakage oc- curred in 4 (3.8%), 16 (9.5%), and 27 (15%) patients in the DT, VN, and OA groups, respectively (P = .01). About 5% of the VN patients needed more than one try for successful trocar insertion. DISCUSSION Although some studies have been carried out to compare laparoscopy entry techniques, adequate data are not yet avail- able. Vilos and colleagues in 2007 concluded that optical tro- car was better than other techniques. They also stated that the visual entry cannula system may represent an advantage over traditional trocars, since it allows a clear optical trocar entry, but this advantage has not been fully explored and they sug- gested more investigation.(9) Altun and associates compared DT and VN techniques and reported 2.2% major complication for VN, but nothing for DT. They also reported 6.7% minor complication for VN and 2.05% for DT. They concluded that surgeon’s preference, skill, anatomic knowledge, and experience are determining factors in the selection of technique.(5) Simforoosh and col- leagues described outcome of 3000 patients that underwent Entry Techniques in Laparoscopy | Shayani-Nasab et al 864 | Medical Center. They concluded that a new version of OA as (6,7,10) Bemelman and associates compared DT, VN, and OA tech- mean trocar insertion time between groups (P < .001), but not for morbidity and gas leakage.(11) Some other studies did rates between the VN and the DT entry techniques.(2,12,13) mainly used by gynecologists, general surgeons, and urolo- gists, respectively. Because of more incidences of some dis- eases, such as undescended testes and varicocele, in young than other groups (P < .05). Furthermore, most patients in DT group were women (P < .001). Mean trocar insertion technique group (P < .001 and P = .01, respectively), which were expected based on the technique. More occurrence of major life-threatening complications were seen in DT than other groups (P = .04). Although minor complications were P = .274). Our study was not without limitations. To eliminate possible confounding factors, such as morbid obesity and previous abdominopelvic surgery, we suggest enrolling more patients and designing a randomized study to enhance the power of the investigation and decrease biases. Furthermore, since various surgeons were involved, surgeon’s experience can CONCLUSION acceptable due to less life-threatening major complications. ACKNOWLEDGEMENTS The authors are grateful to Drs Amir Derakhshanfar (general Laparoscopic Urology Data of different entry techniques in 450 patients who had undergone laparoscopy. Variable Direct Trocar group group (n = 105) Veress Needle group (n = 168) Open Approach group (n = 180) P Mean age ± SD, y 41.37 ± 1.27 35.13 ± 1.61 30.49 ± 1.23 VN/DT: .003 VN/OA<.001 DT/OA: .023 Female, n (%) 86 (81.9%) 91 (54.2%) 35 (19.4%) < .001 Male, n (%) 19 (18.1%) 77 (45.8%) 145 (80.6%) < .001 Mean BMI ± SD, kg/m2 25.2 ± 6.3 26.8 ± 13.1 24.4 ± 5.8 .615 Mean trocar insertion time ± SD, sec 176.94 ± 96.426 331.02 ± 64.405 375.36 ± 63.808 < .001 Urologic cases, n (%) 11 (10.5%) 15 (8.9%) 131 (72.8%) < .001 Gynecologic cases, n (%) 78 (74.3%) 25 (14.9%) 27 (15%) < .001 General surgery cases, n (%) 16 (15.2%) 128 (76.2%) 22 (12.2%) < .001 Minor complications, n (%) 6 (5.8%) 9 (5.4%) 17 (9.4%) .274 Subcutaneous emphysema, n (%) 1 (1.0%) 5 (3.0%) 6 (3.3%) .314 Abdominal wall vessel injury, n (%) 5 (4.8%) 2 (1.2%) 9 (5.0%) .314 Omental hernia, n (%) 0 (.0%) 2(1.2%) 2 (1.1%) .314 Major complications, n (%) 3 (2.9%) 1 (0.6%) 0 .04 Mesenteric vessel laceration 0 0 0 - Intestinal injury, n (%) 1 (1%) 0 0 .085 Solid organ injury 0 0 0 - Major vessel injury, n (%) 2 (1.9%) 1 (0.6%) 0 .085 Gas leakage, n (%) 4 (3.8%) 16 (9.5%) 27 (15%) .01 SD indicates standard deviation; BMI, body mass index; VN, Veress Needle; DT, Direct Trocar; and OA, Open Approach. 865Vol. 10 | No. 2 | Spring 2013 |U R O LO G Y J O U R N A L Entry Techniques in Laparoscopy | Shayani-Nasab et al surgeon), Abbas Moeini (general surgeon), Soghra Rabiei (gynecologist), Mehrangiz Zamani (gynecologist), and Adel Eslami (urology resident) for the use, analysis, and interpre- tation of their laparoscopy data. We are also thankful to the staff of the records section of Shahid Beheshti, Ekbatan, Be- sat, and Fatemieh Hospitals for their help with data collec- tion. CONFLICT OF INTEREST None declared. REFERENCES 1. Philips PA, Amaral JF. Abdominal access complications in laparoscopic surgery. J Am Coll Surg. 2001;192:525-36. 2. Agresta F, De Simone P, Ciardo LF, Bedin N. Direct trocar insertion vs Veress needle in nonobese patients undergo- ing laparoscopic procedures: a randomized prospective single-center study. Surg Endosc. 2004;18:1778-81. 3. Agarwala N, Liu CY. Safe entry techniques during laparos- copy: left upper quadrant entry using the ninth intercos- tal space--a review of 918 procedures. J Minim Invasive Gynecol. 2005;12:55-61. 4. Vilos GA, Ternamian A, Dempster J. Laparoscopic entry: a review of techniques, technologies, complications. Society of Obstetricians, Gynecologists (SOGC) clinical practice guideline no.1993. J Obstet Gynecol Can. 2007;29:433–47. 5. 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