Armin Soave1, Roland Dahlem2, Hans O Pinnschmidt3, Michael Rink2, Jessica Langetepe2, Oliver Engel2, Luis A Kluth2, Birte Loechelt2, Philip Reiss2, Sascha A Ahyai4, Margit Fisch2. 1. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: a.soave@uke.de. 2. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 3. Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 4. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Goettingen, Goettingen, Germany.
Abstract
BACKGROUND: Optimal surgical management of the buccal mucosa harvest site in patients with urethral stricture disease during buccal mucosa graft urethroplasty (BMGU) remains controversial. OBJECTIVE: To analyze in detail intensity and quality of pain as well as oral morbidity following closure (C) versus nonclosure (NC) of the donor site. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial on 135 patients treated with BMGU between October 15, 2014 and December 18, 2015. INTERVENTION: Following computer-based randomization, 63 and 72 patients, respectively, received C and NC of the donor site at the inner cheek. Preoperatively, on days 1, 5, and 21 as well as at 3 and 6 mo postoperatively, patients completed standardized questionnaires, including validated questions on intensity and quality of pain as well as oral morbidity. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The coprimary end points were intensity and quality of oral pain. Secondary end points included oral morbidity and intensity of pain of the perineogenital region. Generalized linear mixed models evaluated the effect of various covariates on intensity and quality of oral pain, oral morbidity, as well as intensity of pain of the perineogenital region. RESULTS AND LIMITATIONS: There was noninferiority for NC versus C in intensity and affective quality of oral pain at every time point following BMGU. Oral morbidity and complications included pain, bleeding, swelling, numbness, alteration of salivation and taste, as well as impairment of mouth opening, smiling, whistling, diet, and speech. Time from BMGU had significant effects on intensity (p<0.001) and quality of oral pain (sensory pain: p<0.001, affective pain: p<0.001, total pain: p<0.001). Length of buccal mucosa graft had significant effects on intensity (p=0.001) and quality of oral pain (sensory pain: p=0.020, total pain: p=0.042). CONCLUSIONS: NC is noninferior to C of the donor site in intensity and quality of oral pain, and offers a treatment alternative. Time from BMGU and length of the buccal mucosa graft have effects on oral morbidity and complications. PATIENT SUMMARY: We investigated pain, morbidity, and complications following closure (C) versus nonclosure (NC) of the buccal mucosa harvest site in patients undergoing buccal mucosa graft urethroplasty (BMGU). We found that NC is not worse than C regarding oral pain. In addition, time from BMGU and length of the buccal mucosa graft have effects on oral morbidity and complications.
RCT Entities:
BACKGROUND: Optimal surgical management of the buccal mucosa harvest site in patients with urethral stricture disease during buccal mucosa graft urethroplasty (BMGU) remains controversial. OBJECTIVE: To analyze in detail intensity and quality of pain as well as oral morbidity following closure (C) versus nonclosure (NC) of the donor site. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial on 135 patients treated with BMGU between October 15, 2014 and December 18, 2015. INTERVENTION: Following computer-based randomization, 63 and 72 patients, respectively, received C and NC of the donor site at the inner cheek. Preoperatively, on days 1, 5, and 21 as well as at 3 and 6 mo postoperatively, patients completed standardized questionnaires, including validated questions on intensity and quality of pain as well as oral morbidity. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The coprimary end points were intensity and quality of oral pain. Secondary end points included oral morbidity and intensity of pain of the perineogenital region. Generalized linear mixed models evaluated the effect of various covariates on intensity and quality of oral pain, oral morbidity, as well as intensity of pain of the perineogenital region. RESULTS AND LIMITATIONS: There was noninferiority for NC versus C in intensity and affective quality of oral pain at every time point following BMGU. Oral morbidity and complications included pain, bleeding, swelling, numbness, alteration of salivation and taste, as well as impairment of mouth opening, smiling, whistling, diet, and speech. Time from BMGU had significant effects on intensity (p<0.001) and quality of oral pain (sensory pain: p<0.001, affective pain: p<0.001, total pain: p<0.001). Length of buccal mucosa graft had significant effects on intensity (p=0.001) and quality of oral pain (sensory pain: p=0.020, total pain: p=0.042). CONCLUSIONS: NC is noninferior to C of the donor site in intensity and quality of oral pain, and offers a treatment alternative. Time from BMGU and length of the buccal mucosa graft have effects on oral morbidity and complications. PATIENT SUMMARY: We investigated pain, morbidity, and complications following closure (C) versus nonclosure (NC) of the buccal mucosa harvest site in patients undergoing buccal mucosa graft urethroplasty (BMGU). We found that NC is not worse than C regarding oral pain. In addition, time from BMGU and length of the buccal mucosa graft have effects on oral morbidity and complications.
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