OBJECTIVE: To determine whether, in performing palatoplasty, fracture of the pterygoid hamulus is beneficial, detrimental, or neutral with respect to intraoperative and perioperative complications, hearing outcome, and speech outcome. DESIGN: Prospective, alternating. SETTING: Institutional, tertiary cleft palate center, Chang Gung Memorial Hospital, Taipei, Taiwan. PARTICIPANTS: A total of 173 patients enrolled in the study, of whom 161 had charts available for analysis. INTERVENTIONS: During the performance of palatoplasty, 85 patients received hamulus fracture and 76 patients did not. All palatoplasties were performed by the same surgeon. MAIN OUTCOME MEASURES: (1) Surgical outcomes, including patient demographic data, palatoplasty type and duration, blood loss, incidences of oronasal fistulae, temporary mucosal dehiscence, and postoperative bleeding; (2) otolaryngological outcomes, including hearing results as judged by auditory brainstem response testing, myringotomy tube data describing rates of tube extrusion, and culture results from sampled effusions; and (3) preliminary speech outcomes as described by judgments of overall velopharyngeal function from perceptual speech samples. RESULTS: No statistically significant differences in any of the measured surgical, otolaryngological, or preliminary speech outcomes were found between the groups who did and did not receive hamulus fracture. CONCLUSIONS: On the basis of these results, we are unable to advocate the performance of hamulus fracture as an operative maneuver during the performance of primary palatoplasty. The historical rationale and theoretical advantage of this maneuver have not been demonstrated here nor have any detrimental effects of the maneuver been measured.
RCT Entities:
OBJECTIVE: To determine whether, in performing palatoplasty, fracture of the pterygoid hamulus is beneficial, detrimental, or neutral with respect to intraoperative and perioperative complications, hearing outcome, and speech outcome. DESIGN: Prospective, alternating. SETTING: Institutional, tertiary cleft palate center, Chang Gung Memorial Hospital, Taipei, Taiwan. PARTICIPANTS: A total of 173 patients enrolled in the study, of whom 161 had charts available for analysis. INTERVENTIONS: During the performance of palatoplasty, 85 patients received hamulus fracture and 76 patients did not. All palatoplasties were performed by the same surgeon. MAIN OUTCOME MEASURES: (1) Surgical outcomes, including patient demographic data, palatoplasty type and duration, blood loss, incidences of oronasal fistulae, temporary mucosal dehiscence, and postoperative bleeding; (2) otolaryngological outcomes, including hearing results as judged by auditory brainstem response testing, myringotomy tube data describing rates of tube extrusion, and culture results from sampled effusions; and (3) preliminary speech outcomes as described by judgments of overall velopharyngeal function from perceptual speech samples. RESULTS: No statistically significant differences in any of the measured surgical, otolaryngological, or preliminary speech outcomes were found between the groups who did and did not receive hamulus fracture. CONCLUSIONS: On the basis of these results, we are unable to advocate the performance of hamulus fracture as an operative maneuver during the performance of primary palatoplasty. The historical rationale and theoretical advantage of this maneuver have not been demonstrated here nor have any detrimental effects of the maneuver been measured.