Comparative analysis of 5-mm trocars: dilating tip versus non-shielded bladed.

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.