Improving patient satisfaction and anatomical fit: a retrospective study on the purse-string suture-assisted disposable circumcision suture device

Abstract

Background

The disposable circumcision suture device (DCSD) faces significant limitations in anatomical adaptability. We developed a novel technique integrating the adjustable purse-string suture (APSS) from proctology to address this unmet need. This study aimed to evaluate the safety and feasibility of APSS-DCSD for circumcision.

Methods

A retrospective cohort study analyzed 93 consecutive patients undergoing circumcision (December 2023–January 2025). Non-randomized allocation stratified patients into: the APSS-DCSD cohort (n=45) and conventional DCSD cohort (n=48). Outcomes measure included operative time, blood loss, complications (frenular injury, infection), intraoperative pain (Visual Analogue Scale, VAS), patient satisfaction, and healing time.

Results

No significant intergroup differences were observed in blood loss (median: 3.2 vs. 3.1 mL; P=0.66), healing time (median: 24 vs. 23 days; P=0.85), or VAS scores (median: 3.0 vs. 4.0; P=0.10). The APSS-DCSD cohort revealed longer operative times [7.0 vs. 6.5 min; 95% confidence interval (CI): 1.708–8.809; P<0.001] and significantly higher satisfaction (median score: 5 vs. 4; 95% CI: 3.414–20.995; P<0.001). Incision infections occurred in three cases overall (APSS-DCSD: 2.2% vs. DCSD: 4.2%; P>0.99). No severe complications (hematoma, frenular injury) were documented in either cohort.

Conclusions

The APSS-DCSD approach significantly improves anatomical precision and patient satisfaction without compromising safety margins. Its standardized protocol demonstrates particular utility in complex anatomies, warranting prospective multicenter validation.

Highlight box.

Key findings

• The adjustable purse-string suture-assisted disposable circumcision suture device (APSS-DCSD) technique eliminated residual prepuce recurrence and achieved superior patient satisfaction compared with conventional DCSD.

What is known and what is new?

• Standard DCSD circumcision faces clinical limitations including poor anatomical adaptation, residual foreskin, and inconsistent cosmetic results.

• In this study, integration of the purse-string suture approach enabled real-time tissue tension adjustment during DCSD procedures, enhancing precision in foreskin excision and extending applicability to challenging cases.

What is the implication, and what should change now?

• APSS-DCSD should be adopted for patients with preputial laxity/fibrosis or requiring revision surgery, replacing conventional static ligation protocols in clinical practice.

Introduction

Male circumcision is a globally prevalent surgical procedure with well-documented benefits, including improved genital hygiene, reduced transmission of infections (e.g., human immunodeficiency virus and human papillomavirus), and decreased incidence of penile cancer (1,2). Although generally safe—exhibiting an overall complication rate of 3.84% [95% confidence interval (CI): 3.35–4.37%]—recognized risks include surgical site infection, hemorrhage, and unsatisfactory cosmetic outcomes (3).

Over the past two decades, minimally invasive circumcision devices have emerged to optimize surgical efficiency, minimize intraoperative pain, and improve cosmetic outcomes. The disposable circumcision suture device (DCSD), pioneered in China [2009] and derived from circular end-to-end bowel staplers (4), represents a landmark innovation in this field. Compared to conventional techniques, DCSD has demonstrated superior perioperative outcomes, including reduced blood loss and shorter operative times (5). Despite these advantages, conventional DCSD remains constrained by residual redundant prepuce—a complication observed in 6.8% of cases at our institution, frequently requiring revision circumcision. This limitation directly correlates with insufficient initial ligation tension during device deployment, compromising resection precision.

To address the inherent limitations of conventional DCSD, we developed a novel modification integrating the adjustable purse-string suture (APSS) technique. Originally pioneered in proctology for Procedure for Prolapse and Hemorrhoids (PPH) (6), the APSS mechanism enables circumferential tension control during foreskin excision. This retrospective study is aimed to evaluate the safety and feasibility of our APSS-assisted DCSD approach. We hypothesize that this approach enhances intraoperative control over foreskin resection, reduces the incidence of residual redundant prepuce, improves cosmetic outcomes, and expands DCSD applicability to anatomically complex cases. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-324/rc).

Methods

Patients

This retrospective comparative cohort study analyzed 93 consecutive adult males with redundant prepuce who underwent circumcision at Yancheng Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine between December 2023 and January 2025. Following the implementation of the modified technique on August 1, 2024, patients were stratified into two consecutive non-randomized cohorts: the conventional DCSD cohort (n=48), patients undergoing standard DCSD procedures (December 2023–July 2024); the APSS-DCSD cohort (n=45), patients undergoing APSS-DCSD procedures (August 2024–January 2025).

Selection criteria

Inclusion criteria

Patients were included if they met all of the following:

1. Age ≥18 years;

2. Kikiros grade <3 phimosis (7);

3. Completed standard preoperative assessment (including complete blood count and coagulation profile).

Exclusion criteria

Patients were excluded for any of the following:

1. Kikiros grade ≥3 phimosis;

2. Active infections of the glans, prepuce, or genital tract;

3. Penile anatomical anomalies (e.g., concealed penis, hypospadias);

4. Uncontrolled diabetes mellitus [hemoglobin A1c (HbA1c) >7.0% or fasting glucose >126 mg/dL];

5. Significant hematologic disorders [international normalized ratio (INR) >1.5, platelets <100×10⁹/L] or uncompensated cardiovascular comorbidities.

Ethics statement

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Institutional Review Board of Yancheng Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine (No. KY250111). Written informed consent was obtained from all participants.

Surgery procedures

All circumcisions were performed as day-case procedures under local anesthesia by a single experienced andrologist. Standard preoperative preparation included penile shaft measurement for device size selection, perineal hair removal, surgical field disinfection with 2% povidone-iodine, sterile draping, and administration of local anesthesia via bilateral penile root block using 2% compound lidocaine.

Key technical differences between conventional DCSD and APSS-DCSD approaches (Figure 1). Conventional DCSD cohort (n=48): procedures followed established protocols (8). Briefly, the prepuce was retracted and elevated. The bell-shaped glans protector was inserted and positioned to safeguard the frenulum. The DCSD was then positioned, circumferentially tensioned to eliminate skin folds, and activated according to manufacturer’s instructions. Operative duration (minutes), blood loss (mL), and intraoperative pain assessed by Visual Analogue Scale (VAS) scores were recorded.

Figure 1.

Key technical differences between conventional DCSD and APSS-DCSD approaches. APSS-DCSD, adjustable purse-string suture-assisted disposable circumcision suture device.

APSS-DCSD cohort (n=45): for patients exhibiting a loose foreskin opening precluding adequate glans coverage by the protector (Figure 2A,2B), the novel APSS technique was employed. Three curved hemostats were applied to the preputial margin at the 2, 6, and 11 o’clock positions. A continuous circumferential purse-string suture was then placed along the preputial margin using a curved needle threaded with 4-0 non-absorbable braided silk suture (Figure 2C-2E). Following insertion of the bell-shaped glans protector, the purse-string suture was tightened and tied, thereby securing the preputial margin adjacent to the coronal sulcus (Figure 2F). The DCSD was subsequently applied and tensioned (Figure 2G). Cutting was completed upon device activation (Figure 2H). Post-resection wound management was identical to the conventional cohort. All patients received standardized postoperative follow-up for 4 weeks (Figure 2I). Figure 3A,3B illustrate the pre-operative loose foreskin opening, Figure 3C,3D demonstrate the purse-string suture placement, Figure 3E shows the immediate post-resection appearance, and Figure 3F depicts the 4-week postoperative result.

Figure 2.

Technical sequence of APSS-DCSD circumcision in Kikiros grade 2 redundant prepuce. (A) Preoperative redundant prepuce obscuring glans exposure. (B) Lateral view demonstrating preputial laxity. (C-E) Purse-string suture placement. (F) Tension adjustment securing preputial margin at coronal sulcus. (G) DCSD deployment with manual fold elimination. (H) Immediate postoperative view showing anatomical alignment. (I) Four-week outcome demonstrating epithelized wound without redundancy. APSS-DCSD, adjustable purse-string suture-assisted disposable circumcision suture device.

Figure 3.

Revision circumcision using APSS-DCSD approach in Kikiros grade 2 redundant prepuce with hypertrophic scarring. (A,B) Preoperative assessment: (A) anterior view showing residual prepuce with fibrotic band; (B) close-up of hypertrophic scar at mucocutaneous junction. (C-E) Intraoperative technique: (C) purse-string suture placement through scar tissue; (D) controlled tension adjustment preserving vascularization; (E) immediate postoperative view showing anatomical alignment. (F) Four-week postoperative outcome: complete epithelialization and absence of residual redundancy. APSS-DCSD, adjustable purse-string suture-assisted disposable circumcision suture device.

Postsurgical treatment

Both cohorts received identical prophylactic antibiotic therapy: oral levofloxacin 500 mg daily for 7 days. Initial wound care involved dressing changes on postoperative day 3, followed by removal of bandages and gauze at 1 week. Daily disinfection with povidone-iodine until complete epithelialization (typically 10–14 days), with strict instructions to maintain wound dryness.

At the 4-week follow-up, clinical assessments documented were as follows: (I) incision healing status (erythema, edema, or dehiscence); (II) infection markers (purulent discharge); (III) postoperative hemorrhage; (IV) titanium staple detachment rate; (V) patient satisfaction graded via a 5-point Likert scale. All participants received standardized instructions to avoid strenuous physical activity for 2 weeks and abstain from sexual intercourse for 1 month. Titanium staples typically shed spontaneously within 2–3 weeks. For patients with retained staples beyond 1 month (<5% expected), manual removal was performed under aseptic conditions using specialized staple extractors.

Evaluations

1. Preoperative characteristics: demographics: age (years), marital status (categorized), and comorbidities. Phimosis severity graded according to the Kikiros classification (Grade 0–5) was documented by two independent urologists.

2. Operative duration: defined as the time interval (minutes) from local anesthetic injection to final wound closure.

3. Blood loss: quantified gravimetrically by weighing blood-saturated gauzes. Blood volume was calculated using the formula: blood loss (mL) = (postoperative gauze weight − preoperative dry weight) ×1.05/3.25 (1.05= specific gravity of blood; 5×5 cm gauze ≈3.25 mL) (9).

4. Frenular injury incidence: diagnosed intraoperatively or during follow-up by blinded surgeons based on direct visualization of frenular integrity.

5. Incision infection rate: determined by experienced surgeons according to wound examination.

6. Healing time: defined as the postoperative day attaining complete epithelialization without complications (painless scar formation, absence of exudate).

7. Intraoperative pain: assessed immediately after surgery using a validated VAS (0= no pain, 10= worst imaginable pain).

8. Patient satisfaction: measured at 2 weeks postoperatively via a 5-point Likert scale (0= completely dissatisfied, 5= fully satisfied).

Statistical analysis

Continuous variable distributions were assessed using the Kolmogorov-Smirnov test. Following normality assessments, non-normal variables were summarized as median (interquartile range, IQR). Between-group comparisons for non-normally distributed continuous variables were conducted using the Mann-Whitney U test. Categorical variables were presented as frequency (percentage) and analyzed via Pearson’s Chi-squared test or Fisher’s exact test, as appropriate. All analyses were conducted in SPSS version 26.0, with statistical significance defined as two-tailed P<0.05.

Results

A total of 93 patients underwent DCSD circumcision. Baseline characteristics, including age, comorbidities, and Kikiros grade distribution, were comparable between the APSS-DCSD (n=45) and conventional DCSD (n=48) cohorts (all P>0.05; Table 1).

Table 1. Baseline demographic and clinical characteristics.

Characteristic	APSS-DCSD (n=45)	DCSD (n=48)	P values
Demographics
Age (years)	30 [26, 35]	32.5 [28, 38]	0.21†
Married	28 (62.2)	31 (64.6)	0.81‡
Comorbidities
Diabetes	4 (8.9)	4 (8.3)	>0.99§
Revision surgery	2 (4.4)	1 (2.1)	0.60§
Kikiros grade			0.11‡
Kikiros 0	2 (4.4)	3 (6.3)
Kikiros 1	16 (35.6)	8 (16.7)
Kikiros 2	27 (60.0)	37 (77.0)

Data are presented as median [interquartile range] or n (%). ^†, Mann-Whitney U test; ^‡, Chi-squared test; ^§, Fisher’s exact test, significance level: P<0.05. APSS-DCSD, adjustable purse-string suture-assisted disposable circumcision suture device.

The APSS-DCSD cohort demonstrated a significantly longer median operative time (7.0 vs. 6.5 min; 95% CI: 1.708–8.809; P<0.001) but higher patient satisfaction (median score: 5 vs. 4; 95% CI: 3.414–20.995; P<0.001). Complication rates were low and did not differ significantly between cohorts: infection occurred in 2.2% (n=1) of APSS-DCSD patients versus 4.2% (n=2) of conventional DCSD patients (difference: −2.0%; P>0.99). No severe complications (e.g., frenular injury or hematoma) were observed. Secondary outcomes—including blood loss (median difference, 0.1 mL; P=0.66), intraoperative pain (median difference, −1.0; P=0.10), and healing time (median difference, 1.0 day; P=0.85)—showed no statistically significant differences (Table 2).

Table 2. Operative and postoperative outcomes.

Outcome	APSS-DCSD (n=45)	DCSD (n=48)	P values
Operative data
Operative time (min)	7.0 [6.5, 7.0]	6.5 [6.0, 7.0]	<0.001†*
Blood loss (mL)	3.2 [3.1, 3.2]	3.1 [3.1, 3.2]	0.66‡
Intraoperative VAS	3.0 [3.0, 4.0]	4.0 [3.0, 4.0]	0.10§
Complications
Incision infection	1 (2.2)	2 (4.2)	>0.99§
Injury of penile frenulum	0 (0.0)	0 (0.0)	–
Residual prepuce	0 (0.0)	0 (0.0)	–
Glans ischemia	0 (0.0)	0 (0.0)	–
Postoperative course
Healing time (day)	24 [23, 24]	23 [23, 24]	0.85†
Patient satisfaction	5 [4.5, 5]	4 [4, 4]	<0.001†*

Data are presented as median [interquartile range] or n (%). ^†, Mann-Whitney U test; ^‡, Chi-squared test; ^§, Fisher’s exact test, significance level: P<0.05; *, P<0.05 compared with the DCSD group. APSS-DCSD, adjustable purse-string suture-assisted disposable circumcision suture device; VAS, Visual Analogue Scale.

The APSS-DCSD approach required a median additional 0.5 minutes operative time but yielded significantly superior patient satisfaction (median difference 1.0 point) without compromising safety, supporting its utility for optimizing aesthetic outcomes.

Discussion

Phimosis, characterized by the inability to fully retract the foreskin to expose the glans penis, arises from both congenital and acquired etiologies (10). Pathologic phimosis in adults typically results from local scarring, infection, or inflammation secondary to factors such as inadequate hygiene, recurrent balanitis, diabetes mellitus, or prior circumcision complications. Treatment strategies vary based on patient age and condition severity (11). Conservative treatment for adult phimosis is an option, but circumcision currently remains the established gold standard for managing adult phimosis and recurrent balanoposthitis (12). Contemporary techniques include open surgical approaches (e.g., sleeve resection, dorsal slit) (13,14) and device-assisted modalities (15-17), each of them with their own advantages and disadvantages. Despite improved methods, device-assisted techniques exhibit critical limitations: incomplete resection (18), which is often underreported due to its primarily cosmetic impact rather than functional impairment.

An optimal circumcision technique necessitates fulfillment of key criteria: procedural standardization, perioperative safety, minimal complication rates (<5%), favorable cosmetic outcomes, and procedural teachability. The absence of validated methods for quantifying phimosis severity and definitive surgical indications poses significant challenges in clinical practice. The Kikiros grading system, initially developed for pediatric phimosis assessment (7,19), provides an objective framework for severity classification. Carilli et al. (11) successfully applied this system to evaluate the PhimoStop™ device in adults, establishing its utility in this population.

Despite standardized DCSD protocols, we summarize three persistent limitations compromise outcomes: (I) device heterogeneity: structural variations across manufacturers, particularly in staple fixation mechanisms (e.g., silicone pad/plastic sheet integration), critically impact staple retention, wound dehiscence risk, and healing quality (16,20,21); (II) visual restriction: the ligation band obscures visualization of the inner prepuce during resection, leading to operator-dependent variability. Common technical errors include insufficient outer prepuce preservation (<5 mm), excessive inner prepuce retention (>10 mm), and frenular displacement. Although modifications like pre-resection marking and tension-adjustable clamps have been proposed (22,23), evidence-based guidelines remain absent; (III) anatomical limitations: DCSD exhibits higher complication rates in specific populations: patients with lax prepuce (Kikiros grades 0–2); obesity [body mass index (BMI) ≥28 kg/m²] with concealed penis (24); elderly patients exhibiting preputial fibrosis (25), and revision cases addressing residual tissue (17,26). These factors collectively constrain DCSD applicability and can adversely affect cosmetic outcomes.

To address the critical limitation of inadequate tissue tension control in DCSD, we integrated the APSS—a technique originally pioneered in proctology for PPH (5). This APSS-DCSD approach demonstrates four principal advantages: (I) precision enhancement: circumferential tension regulation enables anatomical placement at the coronal sulcus, mitigating positional errors; (II) safety preservation: despite a marginal increase in operative time (median Δ=0.5 min; 95% CI: 1.708–8.809; P<0.001), complication profiles remain comparable to conventional DCSD (infection: 2.2% vs. 4.2%; P>0.99); (III) applicability expansion: successful deployment was achieved in anatomically complex scenarios, including severe foreskin redundancy and revision surgeries with residual tissue; (IV) enhanced satisfaction: significantly higher median satisfaction scores (5 vs. 4; 95% CI: 3.414–20.995; P<0.001) were attributable to optimized foreskin positioning and cosmetic outcomes.

Our center observed that the incidence of complications in both groups ranged from 2.2% to 4.2%, consistent with the study by Shabanzadeh et al. (3). There were three cases of incision infection in the two groups, all of which occurred in type 2 diabetes mellitus (T2DM) patients with postoperative glycemic instability. Therefore, postoperative control of patient comorbidities (such as T2DM) is crucial for reducing complications after circumcision. These findings indicate that the APSS-DCSD technique improves aesthetic results while maintaining fundamental safety benchmarks. Given the rapidly increasing adoption of DCSD in China (23), this represents a clinically significant advancement. Notably, this work constitutes documented translation of colorectal surgical principles to andrological device innovation again.

This study acknowledges several limitations. The non-randomized design introduces potential selection bias that may compromise result authenticity and conclusion reliability. Furthermore, methodological constraints require optimization: patients’ awareness of the received technology risks subjective bias in self-reported evaluations of postoperative cosmesis and satisfaction. The baseline characteristics and outcome metrics were also limited in scope. To address these limitations, future investigations should implement double-blinding to minimize assessment bias, incorporate expanded metrics such as BMI, and conduct prospective multicenter randomized controlled trials (RCTs) with extended follow-up periods (e.g., 24 months). Blinded evaluation using validated instruments—including the Patient and Observer Scar Assessment Scale (POSAS) for scar outcomes, functional measures [International Index of Erectile Function-5 (IIEF-5), uroflowmetry], and cost-effectiveness analyses—should be adopted to enhance methodological rigor and provide comprehensive outcome assessment.

Conclusions

The APSS-DCSD technique offers a practical solution for optimizing outcomes in anatomically challenging circumcisions. Its standardized protocol facilitates reproducible implementation while maintaining the efficiency benefits of device-assisted approaches. Validation through prospective trials is warranted to establish long-term efficacy.

Supplementary

The article’s supplementary files as

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Institutional Review Board of Yancheng Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine (No. KY250111). Written informed consent was obtained from all participants.

Data Sharing Statement

Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-324/dss

tau-14-08-2245-dss.pdf ^{(70.6KB, pdf)}

DOI: 10.21037/tau-2025-324