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.

中文翻译：

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闭合性与非闭合性颊粘膜移植物收获部位的置换尿道成形术：一项随机对照试验，详细分析口腔疼痛和发病率

背景

在颊粘膜移植物尿道成形术（BMGU）期间，尿道狭窄疾病患者的颊粘膜收获部位的最佳手术治疗仍存在争议。

客观的

详细分析供体部位闭合（C）与未闭合（NC）后的疼痛强度和质量以及口腔发病率。

设计，设置和参与者

在2014年10月15日至2015年12月18日之间对135例接受BMGU治疗的患者进行了随机对照试验。

干涉

在基于计算机的随机分组之后，分别有63和72位患者的内脸颊接受了供体部位的C和NC。术前，术后第1、5、21天以及术后3、6个月，患者完成了标准化问卷，包括有关疼痛的强度和质量以及口腔发病率的经验证的问题。

成果测量和统计分析

主要终点是口腔疼痛的强度和质量。次要终点包括口腔发病率和会阴区疼痛程度。广义线性混合模型评估了各种协变量对口腔疼痛的强度和质量，口腔发病率以及会阴区疼痛强度的影响。

结果与局限性

在BMGU之后的每个时间点，NC和C在口腔疼痛的强度和情感质量方面均不逊色。口腔发病和并发症包括疼痛，出血，肿胀，麻木，唾液和味觉改变，以及张口，微笑，吹口哨，饮食和言语损害。距BMGU的时间对强度（p  <0.001）和口腔疼痛的质量（感觉痛：p  <0.001，情感性疼痛：p  <0.001，总疼痛：p  <0.001）有显着影响。颊粘膜移植物的长度对强度（p  = 0.001）和口腔疼痛的质量（感觉疼痛：p  = 0.020，总疼痛：p  = 0.042）有显着影响。

结论

NC在口腔疼痛的强度和质量方面不亚于供体部位的C，并提供了替代治疗方法。距BMGU的时间和颊黏膜移植物的长度对口腔发病率和并发症有影响。

病人总结

我们调查了颊粘膜移植尿道成形术（BMGU）患者颊粘膜收获部位闭合（C）与未闭合（NC）后的疼痛，发病率和并发症。我们发现，就口腔疼痛而言，NC并不比C差。此外，距BMGU的时间和颊黏膜移植物的长度也会影响口腔发病率和并发症。