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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Randomized double-masked comparison of radially expanding access device and conventional cutting tip trocar in laparoscopy.
Obstetrics and Gynecology 2001 March
OBJECTIVE: To compare postoperative wound pain associated with the radially expanding access device and the conventional disposable cutting-tip trocar.
METHODS: Our randomized, double-masked, self-controlled study involved 34 women scheduled for laparoscopic adnexal surgery. In each, a 10-mm radially expanding access device was inserted laterally on one side of the lower abdomen and a size-matched disposable cutting-tip trocar was placed on the other side, using random assignment. Postoperative pain for each studied wound and patient satisfaction toward the wounds were assessed using a visual analog scale. Any bleeding complication associated with insertion of the trocar was also recorded.
RESULTS: The radially expanding access device was associated with significant reduction in severity (median 1.4 versus 5.0, P <.001) and duration (median 11 versus 21 days, P <.001) of postoperative wound pain, shorter wound scars (14 versus 17 mm, P <.001), a lower incidence of wound induration (0 versus 9, P <.01), and a higher patient satisfaction (median 9.7 versus 6.2, P <.001). There were four inferior epigastric artery injuries, all at the conventional trocar wound.
CONCLUSION: The radially expanding access device was associated with less postoperative wound pain and more patient satisfaction than the conventional cutting-tip trocar.
METHODS: Our randomized, double-masked, self-controlled study involved 34 women scheduled for laparoscopic adnexal surgery. In each, a 10-mm radially expanding access device was inserted laterally on one side of the lower abdomen and a size-matched disposable cutting-tip trocar was placed on the other side, using random assignment. Postoperative pain for each studied wound and patient satisfaction toward the wounds were assessed using a visual analog scale. Any bleeding complication associated with insertion of the trocar was also recorded.
RESULTS: The radially expanding access device was associated with significant reduction in severity (median 1.4 versus 5.0, P <.001) and duration (median 11 versus 21 days, P <.001) of postoperative wound pain, shorter wound scars (14 versus 17 mm, P <.001), a lower incidence of wound induration (0 versus 9, P <.01), and a higher patient satisfaction (median 9.7 versus 6.2, P <.001). There were four inferior epigastric artery injuries, all at the conventional trocar wound.
CONCLUSION: The radially expanding access device was associated with less postoperative wound pain and more patient satisfaction than the conventional cutting-tip trocar.
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