F Agresta1, P De Simone, L F Ciardo, N Bedin. 1. Unitã Operativa di Chirurgia Generale, Ospedale Civile, Via Forlanini 71, Vittorio Veneto (TV), 31029, Italy. fagresta@libero.it
Abstract
BACKGROUND:Nonobese patients undergoing laparoscopic procedures present a dilemma as to the correct mode of entry into the abdominal cavity because the Veress needle (VN) technique seems to be associated with a high risk of vascular and visceral injuries. Direct trocar insertion (DTI) has been reported as an alternative to the VN for creation of the pneumoperitoneum. METHODS: An open comparative randomized prospective study was conducted on the feasibility and safety of DTI vs the VN technique in nonobese patients of any age category referred for urgent or scheduled laparoscopic procedures. Exclusion criteria were obesity (defined as a body mass index [BMI] > 27 kg/m(2)), major abdominal distension, and two or more previous abdominal operations. The study endpoints were the feasibility and safety of the DTI and VN techniques. Results were evaluated on an intention-to-treat basis. Statistical analysis was carried out with the t-test for independent samples, the chi-square tests, and the Fisher's exact tests, as appropriate. The level of significance was 0.01. RESULTS:Since January 2002, a total of 598 nonobese patients have been entered into the current trial; 46% (mean BMI 21.6 A+/- 4.4 kg/m(2)) were randomly allocated to DTI, whereas 54% (BMI 21.1 A+/- 5.3 kg/m(2)) were allocated to the VN techniques. Demographic features and type of procedures were similar for the two groups. DTI was feasible in 100% of patients vs 98.7% in the VN group (p = NS). Minor complications were nil in the DTI group and 5.9% in the VN group (p < 0.01). The latter group consisted of 11 cases (3.4%) of subcutaneous emphysema and eight cases (2.5%) of extraperitoneal insufflation. Major complications were nil in the DTI group and 1.3% among VN patients (p = NS). These latter cases consisted of two (0.3%) hepatic lesions managed laparoscopically; one (0.3%) misdiagnosed ileal perforation requiring reintervention, and one (0.3%) mesenteric laceration treated conservatively. CONCLUSION: In thin and very thin patients of any age category with no more than one previous abdominal operation, DTI is a safe alternative to the VN technique and is associated with fewer minor complications. In terms of major complications, there is no difference between the two techniques. Either technique of access is acceptable Thin and very thin patients undergoing laparoscopy, on condition that the basic principles of laparoscopic surgery are complied with.
RCT Entities:
BACKGROUND: Nonobese patients undergoing laparoscopic procedures present a dilemma as to the correct mode of entry into the abdominal cavity because the Veress needle (VN) technique seems to be associated with a high risk of vascular and visceral injuries. Direct trocar insertion (DTI) has been reported as an alternative to the VN for creation of the pneumoperitoneum. METHODS: An open comparative randomized prospective study was conducted on the feasibility and safety of DTI vs the VN technique in nonobese patients of any age category referred for urgent or scheduled laparoscopic procedures. Exclusion criteria were obesity (defined as a body mass index [BMI] > 27 kg/m(2)), major abdominal distension, and two or more previous abdominal operations. The study endpoints were the feasibility and safety of the DTI and VN techniques. Results were evaluated on an intention-to-treat basis. Statistical analysis was carried out with the t-test for independent samples, the chi-square tests, and the Fisher's exact tests, as appropriate. The level of significance was 0.01. RESULTS: Since January 2002, a total of 598 nonobese patients have been entered into the current trial; 46% (mean BMI 21.6 A+/- 4.4 kg/m(2)) were randomly allocated to DTI, whereas 54% (BMI 21.1 A+/- 5.3 kg/m(2)) were allocated to the VN techniques. Demographic features and type of procedures were similar for the two groups. DTI was feasible in 100% of patients vs 98.7% in the VN group (p = NS). Minor complications were nil in the DTI group and 5.9% in the VN group (p < 0.01). The latter group consisted of 11 cases (3.4%) of subcutaneous emphysema and eight cases (2.5%) of extraperitoneal insufflation. Major complications were nil in the DTI group and 1.3% among VN patients (p = NS). These latter cases consisted of two (0.3%) hepatic lesions managed laparoscopically; one (0.3%) misdiagnosed ileal perforation requiring reintervention, and one (0.3%) mesenteric laceration treated conservatively. CONCLUSION: In thin and very thin patients of any age category with no more than one previous abdominal operation, DTI is a safe alternative to the VN technique and is associated with fewer minor complications. In terms of major complications, there is no difference between the two techniques. Either technique of access is acceptable Thin and very thin patients undergoing laparoscopy, on condition that the basic principles of laparoscopic surgery are complied with.
Authors: M A Yerdel; K Karayalcin; A Koyuncu; B Akin; C Koksoy; A G Turkcapar; N Erverdi; I Alaçayir; C Bumin; N Aras Journal: Am J Surg Date: 1999-03 Impact factor: 2.565