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Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese
Joseph I Ikechebelu1,2,3, George U Eleje4,5, Ngozi N Joe-Ikechebelu3,6
1Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, P.M.B. 5025, Anambra State, Nigeria.
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.
