BACKGROUND: More than 50% of major laparoscopic complications occur during the initial entry into the abdomen. We investigated the efficacy and the safety of two laparoscopic access techniques: the direct optical access (DOA) versus the classical open entry, as described by Hasson. MATERIALS AND METHODS: Two hundred and two premenopausal women, homogeneous in age, parity, and body mass index undergoing laparoscopic surgery for simple ovarian cysts, were prospectively, randomly assigned to either open or DOA abdominal entry for laparoscopic surgery. The following parameters were compared: duration of access for entry into the abdomen, occurrence of vascular and/or bowel injury, and blood loss. The results were analyzed by using SAS software (SAS Institute, Inc., Cary, NC), considering a P-value of <0.05 as significant. RESULTS: No statistically significant differences were observed in the occurrence of major vascular and/or bowel injury between the two techniques. However, time for establishment of abdominal entry was significantly reduced in the DOA group, as was the blood loss (P < 0.05). CONCLUSIONS: The results of this preliminary comparison on the DOA and the Hasson methods, commonly used by general surgeons and less frequently by gynecologists, suggest that the visual entry system confers a little statistical advantage over the traditional Hasson entry, in terms of safety, minimal time saving, and in reducing blood loss, allowing a safe, fast, visually guided entry.
RCT Entities:
BACKGROUND: More than 50% of major laparoscopic complications occur during the initial entry into the abdomen. We investigated the efficacy and the safety of two laparoscopic access techniques: the direct optical access (DOA) versus the classical open entry, as described by Hasson. MATERIALS AND METHODS: Two hundred and two premenopausal women, homogeneous in age, parity, and body mass index undergoing laparoscopic surgery for simple ovarian cysts, were prospectively, randomly assigned to either open or DOA abdominal entry for laparoscopic surgery. The following parameters were compared: duration of access for entry into the abdomen, occurrence of vascular and/or bowel injury, and blood loss. The results were analyzed by using SAS software (SAS Institute, Inc., Cary, NC), considering a P-value of <0.05 as significant. RESULTS: No statistically significant differences were observed in the occurrence of major vascular and/or bowel injury between the two techniques. However, time for establishment of abdominal entry was significantly reduced in the DOA group, as was the blood loss (P < 0.05). CONCLUSIONS: The results of this preliminary comparison on the DOA and the Hasson methods, commonly used by general surgeons and less frequently by gynecologists, suggest that the visual entry system confers a little statistical advantage over the traditional Hasson entry, in terms of safety, minimal time saving, and in reducing blood loss, allowing a safe, fast, visually guided entry.
Authors: Andrea Tinelli; Antonio Malvasi; Ospan A Mynbaev; Daniel Alberto Tsin; Fausto Davila; Guillermo Dominguez; Emanuele Perrone; Farr R Nezhat Journal: JSLS Date: 2013 Oct-Dec Impact factor: 2.172
Authors: Andrea Tinelli; Nicola Gasbarro; Pietro Lupo; Antonio Malvasi; Daniel A Tsin; Fausto Davila; Guillermo Dominguez; Liselotte Mettler; Paul Alan Wetter Journal: JSLS Date: 2012 Apr-Jun Impact factor: 2.172