Substitution Urethroplasty with Closure Versus Nonclosure of the Buccal Mucosa Graft Harvest Site: A Randomized Controlled Trial with a Detailed Analysis of Oral Pain and Morbidity

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 p p p 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.