OBJECTIVE: Laparoscopic entry techniques vary and still remain debated. We conducted a randomized control trial to compare three entry techniques. STUDY DESIGN:Women aged 18-70 years, nominated for laparoscopic surgery at University of Rome Campus Bio-Medico, were randomized into three different groups: Veress needle (VER), Direct trocar insertion (DIR) and Open technique (OP). For each group, minor complications (extra-peritoneal insufflation, trocar site bleeding, omental injury and surgical site infection), failed entry and time of entry of the main trocar were evaluated. Major complications were also considered. Between-group comparisons were performed using chi-square test. Significance P value was <0.05. RESULTS: A series of 595 consecutive procedures were included: 193 in the VER group, 187 in the DIR group and 215 in the OP group. Minor complications occurred in 36 cases: extraperitoneal insufflation (n=6) in the VER group only, site bleeding (n=2 in the VER group, n=2 in the DIR group and n=1 in the OP group), site infection (n=5 in the VER and n=6 in OP group), and omental injury (n=6 in the VER group and n=3 in the DIR group). Failed entry occurred in 4 cases of the VER group and 1 case of the DIR group. Mean time of entry was 212.4, 71.4 and 161.7s for the VER, DIR and OP groups respectively. Among major complications, one bowel injury resulted following the Veress technique. CONCLUSIONS: In our series, DIR and OP entry presented a lower risk of minor complications compared with VER. In addition, time of entry was shorter in DIR than with OP entry.
RCT Entities:
OBJECTIVE: Laparoscopic entry techniques vary and still remain debated. We conducted a randomized control trial to compare three entry techniques. STUDY DESIGN:Women aged 18-70 years, nominated for laparoscopic surgery at University of Rome Campus Bio-Medico, were randomized into three different groups: Veress needle (VER), Direct trocar insertion (DIR) and Open technique (OP). For each group, minor complications (extra-peritoneal insufflation, trocar site bleeding, omental injury and surgical site infection), failed entry and time of entry of the main trocar were evaluated. Major complications were also considered. Between-group comparisons were performed using chi-square test. Significance P value was <0.05. RESULTS: A series of 595 consecutive procedures were included: 193 in the VER group, 187 in the DIR group and 215 in the OP group. Minor complications occurred in 36 cases: extraperitoneal insufflation (n=6) in the VER group only, site bleeding (n=2 in the VER group, n=2 in the DIR group and n=1 in the OP group), site infection (n=5 in the VER and n=6 in OP group), and omental injury (n=6 in the VER group and n=3 in the DIR group). Failed entry occurred in 4 cases of the VER group and 1 case of the DIR group. Mean time of entry was 212.4, 71.4 and 161.7s for the VER, DIR and OP groups respectively. Among major complications, one bowel injury resulted following the Veress technique. CONCLUSIONS: In our series, DIR and OP entry presented a lower risk of minor complications compared with VER. In addition, time of entry was shorter in DIR than with OP entry.
Authors: Joseph I Ikechebelu; George U Eleje; Ngozi N Joe-Ikechebelu; Chidimma Donatus Okafor; Boniface Chukwuneme Okpala; Emmanuel O Ugwu; Cyril Emeka Nwachukwu; Chukwuemeka C Okoro; Princeston C Okam Journal: Arch Gynecol Obstet Date: 2021-01-08 Impact factor: 2.344