STUDY OBJECTIVE: To examine whether there are statistically significant differences in multiple variables evaluated at different times in the course of surgery and postoperative period when using 5-mm dilating-tip trocars (DTTs) and 5-mm non-shielded-bladed trocars (NSBTs) at randomly selected right or left lateral entry sites on the same patient. DESIGN: Randomized, single-blinded, controlled trial (Canadian Task Force classification I). SETTING: Center for Women's Care and Reproductive Surgery (CWCRS), Atlanta, Georgia. PATIENTS: Ninety-four women, median age 45, undergoing laparoscopic surgery at CWCRS for benign gynecologic conditions were randomly assigned to placement of a DTT to the right or left laparoscopic entry site. The NSBT was placed on the contralateral side of the same patient. INTERVENTION: Each patient had 2 lateral trocars placed, 1 of which was a DTT and the other of which was an NSBT. MEASUREMENTS AND MAIN RESULTS: Comparisons between the sites accessed with the DTT and the NSBT were made by the surgeons at the time of surgery and at the 2-week follow-up, by nurses at 1 and 4 hours after surgery, and by patients at the 2-week follow-up. The nurses and the patients were blinded as to the side of each trocar placement. A visual analog score of 1 to 5 was used for the assessment of 17 studied variables. Questionnaires were standardized and explained to examiners. Wilcoxon's signed-rank test was used for the analysis of time-specific data collected by the same examiner (evaluation by the nurses at 1 and 4 hours after surgery). Friedman's test was applied for analysis of the remaining data. Statistically significant differences were established in ease of placement (chi(2) = 4.691, p = .030) and displacement rate (chi(2) = 7.264, p = .007), in which the NSBT obtained the better results. No statistically significant differences were found in bleeding at the time of placement or removal of the trocars, hematoma/bruising formation, pain, or cosmetic results as assessed by surgeons, nurses, and patients at corresponding stages of intra- and postoperative care. CONCLUSIONS: When used for lateral laparoscopic access in gynecologic surgery, NSBTs were easier to place and had a smaller rate of displacement than DTTs. Despite substantial differences in the design of the trocars, no statistically significant differences in bleeding risk, hematoma/bruising formation, pain, or cosmetic results were established. Individual goals of the surgery and conditions specific to each patient appear to be the best criteria for selection of 1 or the other trocar.
RCT Entities:
STUDY OBJECTIVE: To examine whether there are statistically significant differences in multiple variables evaluated at different times in the course of surgery and postoperative period when using 5-mm dilating-tip trocars (DTTs) and 5-mm non-shielded-bladed trocars (NSBTs) at randomly selected right or left lateral entry sites on the same patient. DESIGN: Randomized, single-blinded, controlled trial (Canadian Task Force classification I). SETTING: Center for Women's Care and Reproductive Surgery (CWCRS), Atlanta, Georgia. PATIENTS: Ninety-four women, median age 45, undergoing laparoscopic surgery at CWCRS for benign gynecologic conditions were randomly assigned to placement of a DTT to the right or left laparoscopic entry site. The NSBT was placed on the contralateral side of the same patient. INTERVENTION: Each patient had 2 lateral trocars placed, 1 of which was a DTT and the other of which was an NSBT. MEASUREMENTS AND MAIN RESULTS: Comparisons between the sites accessed with the DTT and the NSBT were made by the surgeons at the time of surgery and at the 2-week follow-up, by nurses at 1 and 4 hours after surgery, and by patients at the 2-week follow-up. The nurses and the patients were blinded as to the side of each trocar placement. A visual analog score of 1 to 5 was used for the assessment of 17 studied variables. Questionnaires were standardized and explained to examiners. Wilcoxon's signed-rank test was used for the analysis of time-specific data collected by the same examiner (evaluation by the nurses at 1 and 4 hours after surgery). Friedman's test was applied for analysis of the remaining data. Statistically significant differences were established in ease of placement (chi(2) = 4.691, p = .030) and displacement rate (chi(2) = 7.264, p = .007), in which the NSBT obtained the better results. No statistically significant differences were found in bleeding at the time of placement or removal of the trocars, hematoma/bruising formation, pain, or cosmetic results as assessed by surgeons, nurses, and patients at corresponding stages of intra- and postoperative care. CONCLUSIONS: When used for lateral laparoscopic access in gynecologic surgery, NSBTs were easier to place and had a smaller rate of displacement than DTTs. Despite substantial differences in the design of the trocars, no statistically significant differences in bleeding risk, hematoma/bruising formation, pain, or cosmetic results were established. Individual goals of the surgery and conditions specific to each patient appear to be the best criteria for selection of 1 or the other trocar.
Authors: Stavros A Antoniou; George A Antoniou; Oliver O Koch; Rudolph Pointner; Frank A Granderath Journal: Surg Endosc Date: 2013-02-07 Impact factor: 4.584