Preliminary Study on the Application of Nanochitosan Film and Petrolatum Gauze in the Modified Devine Operation.

Although the use of sterile petroleum jelly gauze combined with nanochitosan film to wrap wounds has been proven to have good results, it has not been applied for modified Devine surgery. The use of sterile petroleum jelly gauze alone in the modified Devine surgery to treat concealed penis in children has different effects. In this study, the systematic evaluation of the effect of the modified Devine technique (Vaseline gauze bandaging the wound) in the treatment of concealed penis in children is conducted. Furthermore, the application of nanochitosan film and Vaseline gauze in the modified Devine technique is proposed. By analytical search in PubMed, China Knowledge Network (CKN), and other Chinese and foreign literature databases, there are 13 studies describing the development of the penis during the follow-up period with high satisfaction of patients and their family members. In addition, systematic evaluations have shown that the complete removal of the fibrotic penile sarcoid tissue is an important reason for the remarkable curative effect of the modified Devine surgery in the treatment of concealed penis in children.

1. Introduction

Concealed penis (CP), also called buried or hidden penis, is a common congenital dysplasia and deformity. The penile body of CP patients is shrunk and hidden in the body, and only the pointed small foreskin protrudes outside. If you squeeze the skin of the penis inward with your hands, the body of the penis will be exposed, and when the hand is slightly released, the body of the penis will retract. Although CP looks like a long foreskin, they are two completely different diseases. The causes of CP are congenital peritoneal tissue development abnormalities and obesity, which mostly occur in children [1, 2]. CP can cause abnormalities in the function and structure of the cavernous body of the penis and even have a great impact on the growth and development and psychological behavior of patients [3]. However, due to insufficient understanding of the clinical features and etiology of CP, the diagnosis is different, and it is easy to be misdiagnosed and missed [4].

In addition, there are many surgical treatments for CP, each with its own advantages and disadvantages [5]. Therefore, it has always been the focus of clinical urology to recognize the clinical characteristics of CP patients, understand the cause, and find more effective surgical procedures. There is a lot of controversy about the treatment of CP and the age of surgery. Some scholars believe that the earlier the age of operation, the better the effect of operation. Others believe that the foreskin can be turned up to expose the glans of the penis, without surgery, and CP will gradually get better with age. Despite the continuous advancement of medical technology, the treatment of concealed penis is still surgery. In recent years, clinical technical treatment of nanomaterials has brought great help to the treatment of urinary system diseases, for example, the application of nanomaterials in penile erectile dysfunction [6, 7]and the treatment of urethral reconstruction by nanomaterials [8, 9]. However, there is no report about its application in the treatment of concealed penis. And the effect of using sterile petrolatum gauze alone in the modified Devine operation to treat concealed penis in children is different. Therefore, this topic starts from the systematic evaluation of the effect of the modified Devine technique (Vaseline gauze bandaging the wound) in the treatment of concealed penis in children, and then studies the application of nanochitosan film and Vaseline gauze in the modified Devine technique. This study analyzes the clinical characteristics of patients with concealed penis using modified Devine surgery, summarizes the experience of surgical treatment, and hopes to provide a reference for clinical treatment of concealed penis.

2. Related Work

Clinically, there are many surgical procedures for CP, but they all have different degrees of complications, and there is no very satisfactory surgical procedure. For example, the Brisson operation can loosen and fix the fascia sufficiently, but the ventral skin covers the defect, which is affected by the return of blood and lymph fluid, and the postoperative edema is heavier [10, 11]. Its modified surgical method uses scrotal skin and flap technology to cover ventral skin defects, and the postoperative appearance is still insufficient [12]. Pedicled island flap surgery is suitable for CP combined with penile-scrotal fusion and scrotal transposition, which can effectively restore the length of the penis, but the appearance of the penis is inconsistent in skin color and so on.

The Devine operation is simple and is a commonly used operation method for children with CP. However, the traditional Devine operation can fully remove the abnormally developed fascia [13, 14]. Since the root of the penis is not fixed, the incidence of postoperative retraction of the penile body is greater. With the continuous improvement of the medical level and clinical skills, the Devine operation has been improved clinically [15]. Compared with the traditional Devine technique, the improved Devine technique is mainly improved in three places; first is to loosen the tissue of the fibrous cord outside the penis fascia, second is to fix the skin tissue and Buck's fascia at the root of the penis, and third is to rebuild the outer skin of the penis. However, there is no report on the systematic evaluation of the modified Devine procedure [16].

In this study, we searched PubMed, China Knowledge Network (CKN), and other Chinese and foreign literature databases. A total of 15 studies were included, including 1057 patients. The age of the children included in the studies ranged from 2 to 15 years. Clinically, it has been found that the older the children with CP, the greater the impact on their psychological behavior. Studies have shown that the later the surgery is performed, the more obvious the child's inferiority complex and behavior may be, and it may have a certain impact on their adult sexual function [17]. Therefore, some researchers suggest that the earlier the operation period for children with CP, the better. However, some scholars believe that the operation should be performed after the child is 3 years old because the child has passed the physiological obesity period at the age of 3. The fat under the abdominal wall has been redistributed and improved [18]. The penis is gradually developing, and it can be identified whether it is a true CP [19]. Considering that the reproductive system of adolescents is in a stage of rapid development, surgery should be performed before puberty to avoid affecting the development of adolescents and sexual function in adulthood. Therefore, this study recommends that the operation period is the most appropriate period from 3 years of age to before puberty. However, other relevant circumstances of the child and his family should also be considered.

Seven studies in this study reported the operation time. The average operation times for Deng 2008, Chen 2009, and Feng 2016 were 40 min, 30 min, and 45 min, respectively. Li 2019 was treated with a modified Devine technique, but the two groups were fixed with biofilm penile root fixation and silk thread fixation and the time spent was 36.5 ± 5.1 (min) and 53.8 ± 6.6 (min), respectively. In the study of Ge (2019), Xing (2018), and He (2017), the average operation time was 87.5, 88.8, and 40 (min), respectively. Only Feng (2016) mentioned intraoperative blood loss, which was 4 mL. This shows that the modified Devine procedure for the treatment of CP in children has stable operation time, low blood loss, and high intraoperative safety.

Some studies mentioned incision healing, and the incisions of the children healed by first intention [20, 21]. Also, the length of the penis was lengthened after surgery, and the length of the penis in children treated with the modified Devine procedure was better than that before the operation. This shows that the modified Devine procedure is effective in treating CP in children.

In terms of postoperative complications, the main manifestations are postoperative edema and infection of the foreskin of the penis. All children had penile lymphedema after surgery. The incidence of edema in Liu (2009), Xing (2018), Deng (2008), Ding (2008), and Li (2019) were 18.52%, 90.4%, 13.89%, 13.33%, and 19.66%, respectively [5, 22]. The incidence of severe edema in Su (2007) and Feng (2016) was 45.71% and 5.70% (9/158), respectively. An 2007, Qu 2006, and Su 2007 mentioned refractory edema without penile foreskin. Severe edema will recover after 1–3 months or even half a year [23]. This shows that the modified Devine technique is used to treat CP in children, and the possibility of penile foreskin edema after surgery is very high, but it can be treated symptomatically or will subside after several months. In terms of infection, only 4 studies mentioned infection. Among them, Ge (2019), Yang (2005), and Liu (2009) studies showed that there was no obvious infection after surgery [24, 25]. The Li (2019) study showed that the infection rate was 5.98%. It suggests that the incidence of infection after the modified Devine procedure is low in the treatment of CP in children.

There are 13 studies describing the development of the penis during follow-up. The foreskin turns up naturally; the glans penis is exposed, flexible, and barrier-free; prepuce and penis attachment; satisfied with the appearance; g erection; no stenosis ring [26]. This further shows that the improved Devine technique is effective in treating CP in children, and the patients and their families are highly satisfied. In addition, Yang (2005) found that 18 cases of pathological examination showed that the resected tissue was fibrous connective tissue, with fibroblasts and collagen fibers in the tissue [27]. An (2007) found that the resection specimens all had abnormal fibrous tissue, and 2 cases contained adipose tissue [19]. Chen (2013) directly discovered that the key to surgery is to completely remove the fibrotic penile sarcoid tissue. It can be seen that the effective removal of the fibrotic penile sarcoid tissue by the modified Devine technique in the treatment of CP in children is an important reason for its good effect. Vaseline gauze was used to bandage the wound in the modified Devine operation in this study, and the effect was obvious [28]. However, there are still some patients whose wound infection affects efficacy. Therefore, the application of nanochitosan film and petrolatum gauze in the modified Devine operation may be an effective measure to improve its curative effect [29]. This conclusion awaits our next research and demonstration.

In the search process of this study, it was found that there are fewer case-control studies and randomized controlled studies in the related studies on the modified Devine procedure for the treatment of CP in children. This is also the shortcoming of this study. Therefore, this research needs more high-quality research to support and verify.

3. Materials and Methods

3.1. Search Strategy

PubMed, CNKI, and other Chinese and foreign literature databases were searched using a computer. The search terms are as follows: Devine operation for recurrent inguinal hernia, modified Devine operation, concealed penis, and pediatric/child. A combined search of the search terms was performed.

3.2. Inclusion and Exclusion Criteria

Inclusion criteria were as follows: (1) it is clearly diagnosed as a concealed penis; (2) the research objects are children; (3) the operation method is the modified Devine operation; and (4) languages are not limited. Exclusion criteria were as follows: (1) animal experimental research, conference abstracts and review articles, duplicate literature, and unpublished literature; (2) it is a retrospective study; (3) relevant specific data cannot be obtained; and (4) the subjects of the study are adults.

3.3. Quality Evaluation of the Included Literature

The literature quality evaluation was done independently by two evaluators, and the literature with different opinions was decided after discussion or a third party decides whether to include the literature. The quality of the literature was assessed according to Newcastle–Ottawa Scale (NOS), including the following: (1) Selection of subjects (0 to 4 points): the definition of the case and whether the diagnosis is appropriate, whether the case is representative, and the choice and definition of the control group. (2) Comparability between groups (0 to 2 points): whether the case group and the control group are comparable in the design and statistical analysis. (3) Exposure factor measurement (0–4 points): whether the determination of exposure investigation and assessment methods are the same; whether the research methods of the case group and the control group are the same; whether the nonresponse rate is the same. The NOS scale evaluation score is up to 10 points, and the higher the score, the better the quality of the literature. The literature with a literature score ≥ 5 points was included in this study.

3.4. Data Extraction

Two researchers independently searched and included the literature, discussed in disputes, or decided by a third party. The document screening process is as follows: Preliminary screening of document titles and abstracts. Read through the full text for further screening. Finally, documents that meet the inclusion criteria were included. The content of the literature extraction includes the following: research author, publication period, research object country, age, sample size, operation method, clinical characteristics, and observation index before and after operation.

3.5. Statistical Analysis

3.5.1. Selection of Effect Indicators and Clinical Significance

Rev Man 5.3 software was used for statistical analysis. The research data is a binary variable, and the results are expressed in odds ratio (OR) and its 95% confidence interval (95% CI).

3.5.2. Heterogeneity Test and the Effect Model

The Q test was used to test the heterogeneity first, and P>0.1 and I2<50% indicate that there is no statistical heterogeneity among the studies, and the fixed-effects model (FEM) was used for analysis. If heterogeneity exists, the random-effects model (REM) was used for analysis.

4. Results and Discussion

4.1. Literature Search Results

1204 articles were seized for the first time. A total of 34 documents were screened out by screening titles, abstracts, and duplicate documents. The full-text reading of these 34 articles was further screened, and a total of 15 studies were finally included, including 1057 patients. Among them comes from Baidu Academic and CNKI. The literature screening process is shown in Figure 1.

Figure 1

Document retrieval flow chart.

4.2. Clinical Characteristics of Each Study

4.2.1. Proportion of Sample Size of Each Study

According to the sample size analysis of the proportion of each research in this study, the proportion of sample size from large to small is He (2017), Feng (2016), Li (2019), Ge (2019), Xing (2018), Cheng (2009), Yang (2005), Deng (2008), Su (2007), Zhan (2011), Liu (2009), Qu (2006), An (2007), Ding (2008), and Chen (2013), of which He (2017) accounted for the largest proportion, as shown in Figure 2.

Figure 2

Proportion of sample size of each study.

4.2.2. The Age of the Child

The age of the children studied by An (2007) was 8–14 years (no mean value), and the ages of the children in the other studies ranged from 2 to15 years (the difference in patient age between different studies was statistically significant, t=2.300, P=0.025), as shown in Figure 3.

Figure 3

Age of children in each study.

4.3. Observation Indicators before and after Surgery

4.3.1. Operation Time and Intraoperative Blood Loss

Seven studies reported the operation time. The average operation times for Deng (2008), Chen (2009), and Feng (2016) were 40 min, 30 min, and 45 min (only the mean value), respectively. Li (2019) (117 cases) was treated with the modified Devine technique, but the two groups were fixed with biofilm penile roots and silk thread. The time difference was large, 36.5 ± 5.1 / 53.8 ± 6.6 (min), t=15.763, P<0.001. The average operation times of the other three studies (Ge 2019, Xing 2018, and He 2017 sample sizes were 79, 73, and 327, respectively) were 87.5, 88.8, and 40 min. The difference between the three was not statistically significant (t = 0.167, P = 0.867), as shown in Figure 4. Only Feng 2016 mentioned the amount of intraoperative blood loss, which was small, 4 mL.

Figure 4

Operation time used in each study.

4.3.2. Modified Penis Length before and after the Devine Operation

In 8 studies, the length of the penis was lengthened in each study. Except that Zhan 2011 only mentioned that the length of the penis was significantly longer than that before the operation, the other lengths are shown in Table 1.

Table 1

Postoperative penis lengthening.

Included studies	n	Extension, mean (range)/mean ± standard deviation
Yang (2005)	50	Postoperative extension 1.8 cm (1.5−2.5 cm)
An (2007)	18	Before operation: 0.52.5 cm, after operation: 46 cm (more than doubled)
Deng (2008)	36	Postoperative extension 2.0 cm (1.5−2.5cm)
Cheng (2009)	62	Average extension 2.1 cm
Feng (2016)	158	Postoperative extension 3.4 cm
Xing (2018)	76	Extension 3.48 ±1.22 cm
Li (2019)	117	Extension 4.40±1.25 cm

4.3.3. Meta-Analysis

A meta-analysis of two studies with preoperative and postoperative penis lengths expressed as mean ± standard deviation was performed. There is heterogeneity between the two studies, so the random-effects model is used. The results showed that the length of the penis after the operation was greater than that before the operation, and the difference was significant (MD = 2.97, 95% CI: 2.12 3.82, P<0.0001), as shown in Figure 5.

Figure 5

Forest diagram of penis length before and after surgery.

4.3.4. Incision Healing

Only 5 studies (Qu (2006), Xing (2018), Ding (2008), An (2007), and Zhan (2011)) mentioned incision healing, and the incisions of the children healed by first intention.

4.3.5. Degree of Postoperative Edema

Postoperative edema: in 3 studies (Qu 2006, Ge 2019, and Zhan 2011), children had penile lymphedema after surgery. The incidence of edema in Liu 2009 was 18.52 (5/27), the incidence of edema in Xing 2018 was 90.4% (66/73), the incidence of edema in Deng 2008 was 13.89% (5/36), the incidence of edema in Ding 2008 was 13.33% (2/15), and the incidence of edema in Li 2019 was 19.66% (23/117).

Severe edema: the incidence of severe edema in Su (2007) was 45.71% (16/35), and the incidence of severe edema in Feng 2016 was 5.70% (9/158). An (2007), Qu (2006), and Su (2007) mentioned refractory edema without penile foreskin.

Time for edema to disappear: after symptomatic treatment (Liu 2009) or 1 week to 3 months after surgery (Cheng 2009, Xing 2018, He 2017, Deng 2008, Zhan 2011), (Su 2007) severe edema 1-3 months or even (Feng 2016) half a year before recovery.

4.3.6. Infection

Only 4 studies mentioned infections, among which Ge 2019, Yang 2005, and Liu 2009 studies showed that there was no obvious infection after surgery. The Li 2019 study showed that the infection rate was 5.98% (7/117).

4.3.7. Follow-Up

There are 4 studies mentioning the follow-up rate (An 2007, Su 2007, Liu 2009, Yang 2005), the follow-up rates were 100.0% (18/18), 74.29 (26/35), 100.0% (27/27), 82.0 % (41/50). There are 14 studies mentioning the follow-up time, and the follow-up time is shown in Table 2.

Table 2

Follow-up time of each study.

Included studies	Follow-up time
Yang 2005 [10]	3 months−5 years
Qu 2006 [11]	6 months−3 years
An 2007 [12]	3 months
Su 2007 [13]	3−24 months
Deng 2008 [14]	6 months
Ding 2008 [15]	3−12 months
Cheng 2009 [16]	1 − 10 years
Liu 2009 [17]	6 months − 5 years
Zhan 2011 [18]	6 months−2 years
Feng 2016 [19]	14 months
He 2017 [20]	1−12 months
Xing 2018 [21]	6 months−2 years
Ge 2019 [22]	27.52 ± 12.50 months
Li 2019 [5]	6−12 months

4.3.8. Development

There are 13 studies describing the development of the penis during follow-up as follows: the penis is straight and well developed; the foreskin turns up naturally; the glans penis exposure; flexible and barrier-free; prepuce and penis attachment; satisfied with appearance; good erection; no stenosis ring. The number of studies included in each developmental situation is shown in Figure 6.

Figure 6

Development status and the number of included studies.

5. Conclusions

In this systematic study, the ages of the children included in the study ranged from 2 to 15 years. The average operation time was stable, the blood loss was low, and the intraoperative safety was high. And, the child's incision achieved first-stage healing. The length of the penis after the modified Devine operation was greater than that before the operation, and the difference was significant. In terms of postoperative complications, the main manifestations are postoperative edema and infection of the foreskin of the penis, and no obvious intractable edema of the foreskin of the penis. Aiming at wound infections, our group speculates that nanochitosan film and petrolatum gauze have better bandaging effects. Symptomatic treatment or recovery from 1 week to several months after surgery is required. The incidence of postoperative infection is low. Patients and their families are highly satisfied. In addition, systematic evaluations have shown that the complete removal of the fibrotic penile sarcoid tissue is an important reason for the remarkable curative effect of the modified Devine surgery in the treatment of CP in children. In future works, we will further study and take active nursing and preventive measures to avoid and reduce the complications of hidden penis treated by the modified Devine method.