Impact of incision preference and umbilical care on laparoscopic cholecystectomy outcomes: A randomized controlled trial

Abstract

BACKGROUND

Laparoscopic cholecystectomy (LC) is widely accepted as the standard surgical treatment for gallbladder diseases due to its advantages: Reduced postoperative pain, shorter hospital stay, and faster recovery. Despite these benefits, port-site-related complications remain a crucial clinical issue. The umbilicus is commonly used for initial access to the peritoneal cavity; however, its anatomical structure predisposes it to bacterial colonization, raising concerns regarding surgical site infection and incisional hernia, particularly when a transumbilical incision is used. Although transumbilical access offers shorter operative time and superior cosmetic outcomes, its safety remains debated as standard preoperative skin preparation may not adequately eliminate umbilical microflora. Evidence regarding the effectiveness of additional umbilical care in reducing complications associated with transumbilical access is limited.

AIM

To compare operative time, surgical site infection, length of hospital stay, postoperative cosmetic satisfaction, scar healing, and incisional hernia rates in LC patients receiving either transumbilical incision with additional umbilical care or a periumbilical incision with standard preoperative care.

METHODS

This prospective randomized controlled study was conducted at a tertiary-level university hospital. Patients aged ≥ 18 years who were scheduled for elective LC and met the inclusion criteria were enrolled. In total, 88 patients were assessed, and 80 patients who completed follow-up were randomized into two equal groups. In the intervention group, preoperative umbilical care with chlorhexidine gluconate was applied twice (once 6 hours before surgery and once immediately before skin preparation); trocar entry was performed via a transumbilical incision. In the control group, standard skin preparation was applied, and trocar entry was achieved through a periumbilical incision. The operative time, surgical site infection, the length of hospital stay, cosmetic satisfaction, scar healing, and incisional hernia were evaluated. Cosmetic satisfaction was assessed using a visual analog scale and scar quality using the patient and observer scar assessment scale. Patients were followed during hospitalization and reassessed at the first postoperative month.

RESULTS

Baseline demographic and clinical characteristics were similar between the two groups. No significant differences were observed in surgical site infection rates, the length of hospital stay, or incisional hernia occurrence between groups. Operative time was significantly shorter in the transumbilical incision group. Postoperative cosmetic satisfaction scores were significantly higher in patients who had a transumbilical incision. Patient- and observer-reported scar assessment scores demonstrated significantly better scar healing outcomes in the transumbilical incision group.

CONCLUSION

Transumbilical access combined with appropriate preoperative umbilical care can be safely used in LC. This approach offers complication rates comparable to the periumbilical technique, with the advantages of shorter operative time, improved scar quality, and higher postoperative cosmetic satisfaction.

Key Words: Cosmetic outcome; Laparoscopic cholecystectomy; Periumbilical incision; Scar healing; Surgical site infection; Transumbilical incision; Umbilical care

Core Tip: Port-site selection and preoperative umbilical preparation are crucial but insufficiently addressed determinants of laparoscopic cholecystectomy outcomes. In this prospective randomized study, transumbilical access combined with targeted umbilical care using chlorhexidine gluconate shortened operative time while improving postoperative cosmetic satisfaction and scar healing. This approach did not increase the rates of surgical site infection or incisional hernia compared with standard periumbilical access. These findings indicate that meticulous umbilical care enables safe transumbilical entry and offers a simple, low-cost strategy to enhance surgical efficiency and patient-centered outcomes in routine laparoscopic cholecystectomy.

INTRODUCTION

With the advancement of minimally invasive surgical techniques, laparoscopic approaches have become widely used across various surgical procedures[1-4]. In recent years, developments in laparoscopic cholecystectomy (LC) have focused on reducing invasiveness through fewer port entries, smaller abdominal incisions, or natural orifice approaches, such as transvaginal and transgastric access, to improve cosmetic outcomes[2,3]. However, these techniques require advanced surgical expertise and are associated with a prolonged learning curve[2-6].

A critical step in laparoscopic surgery is initial access to the peritoneal cavity, which is achieved via the periumbilical route[7-10]. Although less frequently used, transumbilical access has been successfully applied in several procedures, including Roux-en-Y gastric bypass, appendectomy, cholecystectomy, and colorectal surgery[9-11]. Transumbilical entry does not require additional experience compared with the periumbilical approach for creating a pneumoperitoneum[7].

In periumbilical access, transverse or U-shaped incisions are made above or below the umbilicus, while transumbilical access involves a vertical or transverse incision along the entire length of the umbilicus[7-10]. Although transumbilical access provides several advantages (e.g., fewer tissue layers being incised, easier fascial closure with a single suture, reduced operative time, and improved cosmetic outcomes), concerns regarding bacterial colonization of the umbilicus and the potential risks of surgical site infection and incisional hernia have limited its widespread adoption[4,7,12]. Previous studies have found that standard preoperative antiseptic skin preparation may not completely eliminate umbilical microflora, and current guidelines do not provide specific recommendations for preoperative skin preparation in naturally contaminated anatomical regions[13-15]. Consequently, evidence regarding the safety of transumbilical access following adequate preventive measures remains limited[4,7,9,10]. The present study aimed to compare early postoperative outcomes between LC patients receiving transumbilical incision with additional umbilical care and those receiving periumbilical incision with standard care.

MATERIALS AND METHODS

Study design and setting

This prospective randomized controlled study was conducted at a tertiary-level university hospital between January 1 and May 1, 2022. Patients scheduled for elective LC with American Society of Anesthesiologists physical status I-II and no cognitive impairment and who voluntarily agreed to participate were included in the study.

Ethical approval

The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants for the surgical procedures and publication. Ethical approval was obtained from the Clinical Trials Ethics Committee, No. 0160. The study was not registered in a public clinical trial registry.

Inclusion criteria

Patients aged ≥ 18 years who were scheduled to undergo elective LC at our hospital and who volunteered to participate in the study were included.

Exclusion criteria

Patients were excluded if they were older than 80 years, had an acute infection, experienced major intraoperative complications, had gallbladder perforation and bile spillage, and refused preoperative umbilical care or participation in the study.

Patient selection and randomization

Eighty-eight patients were assessed for eligibility. After excluding patients who declined participation or were lost to follow-up, data from 80 patients were analyzed. Randomization was conducted using a computer-generated randomization scheme (http://www.randomization.com), and patients were grouped into two. Figure 1 presents the workflow chart detailing patient selection and randomization into study groups.

Figure 1 Research flow diagram based on CONSORT statement 2010.

Surgical procedure

All patients received prophylactic antibiotic treatment with 1 g of intravenous cefazolin administered within 30 minutes before skin incision. All procedures were performed using a standardized four-port technique under general anesthesia. Pneumoperitoneum was established using a Veress needle, with a maximum insufflation pressure of 12 mmHg. Two 5 mm and two 11 mm trocars were used. Two 5 mm trocars were placed in the right subcostal area, one 11 mm trocar was inserted in the epigastric region, and the gallbladder was extracted through the epigastric trocar using an endoscopic retrieval bag in all cases. In both groups, the fascia was closed using nonabsorbable sutures. All procedures were performed by the same experienced hepatobiliary surgeon, and the study included only patients undergoing elective LC. The differences between the two study groups were the site and preparation of the initial trocar entry.

In the umbilical care and transumbilical incision (UCTI) (intervention) group (n = 40), trocar entry was achieved through a transumbilical incision during surgery (Figure 2A). Umbilical care with chlorhexidine gluconate was applied twice: Once 6 hours before surgery and once immediately before skin preparation. Umbilical care was conducted by a surgical nurse. Chlorhexidine gluconate was instilled into the umbilicus, a sterile swab was wrapped around a sterile forceps, and the forceps was inserted into the umbilicus and rotated three times. This procedure was repeated three times during each umbilical care session. In the standard care and periumbilical incision (SCPI) (control) group (n = 40), standard preoperative skin preparation was performed, and trocar entry was achieved via a periumbilical incision.

Figure 2 Transumbilical thoracar placement and postoperative cosmetic result. A: Placement of the thoracar via transumbilical incision; B: Cosmetic outcome of the transumbilical incision site at 1 month postoperatively.

Patient follow-up

Patients were followed during hospitalization and reassessed at the postoperative 1-month outpatient visit for surgical site infection, incisional hernia, cosmetic satisfaction, and scar healing. Surgical site infections were classified as superficial incisional, deep incisional, or organ/space infections based on the Centers for Disease Control and Prevention criteria[16]. If multiple primary incisions developed infection in the same patient, only one surgical site infection was recorded.

Outcome measures

The primary outcomes were operative time, surgical site infection, length of hospital stay, postoperative cosmetic satisfaction, scar healing, and incisional hernia. Early postoperative outcomes were considered for evaluating incisional hernia.

Data collection tools

Cosmetic satisfaction: Postoperative cosmetic satisfaction was assessed using a visual analog scale ranging from 0 (not satisfied at all) to 10 (extremely satisfied).

Scar assessment: Postoperative wound healing and scar status were evaluated using the patient and observer scar assessment scale (OSAS), which was developed by Draaijers et al[17] in 2004. The validity and reliability of this scale was determined by Kabuk et al[18]. The patient scar assessment scale (PSAS; α = 0.992) and OSAS (α = 0.993) were found to be valid and reliable for use in Turkish populations[19,20]. In both scales, the first six items have a Likert-type scoring between 1 and 10:1 indicates normal skin, and 10 indicates the worst scar evaluation. Scale scores range from 6 (normal skin) to 60 (worst scar imaginable); in both subscales, the scale score is calculated based on the first six items. Item 7, which assesses scarring, is scored between 1 and 10, with 1 indicating normal skin and 10 the worst scar[19]. After the scores of the first six items of the PSAS and OSAS were evaluated, item 7 was assessed and scored separately. Accordingly, four distinct scores were calculated for each patient: PSAS, PSAS item 7, OSAS, and OSAS item 7. Observer assessments were performed by trained physicians and nurses using the validated patient and OSAS. To assess interobserver agreement, kappa values were obtained based on the scores assigned by each observer during the evaluation of the first 10 patients. The calculated kappa values were 0.674 for OSAS and 0.759 for OSAS item 7. Based on these results, a moderate level of interobserver agreement was noted. Figure 2B shows the cosmetic outcome of the transumbilical incision site at 1 month postoperatively.

Incisional hernia: Incisional hernia was assessed by physical examination and confirmed by ultrasonography when clinically suspected.

Statistical analysis

Statistical analyses were performed using IBM SPSS Statistics for Windows. Descriptive statistics were expressed as n (%), mean ± SD, or median (minimum-maximum). Normality of distribution was assessed using histogram curves, skewness and kurtosis values, and the Shapiro-Wilk test. Categorical variables were compared using the χ² test. Additionally, continuous variables were compared using Student’s t-test for normally distributed data and the Mann-Whitney U test for non-normally distributed data. Results were evaluated at a 95% confidence interval, and P < 0.05 was considered statistically significant.

Post hoc power analysis

No a priori sample size calculation was performed. All patients presenting during the study period were enrolled in accordance with the predefined inclusion and exclusion criteria. Therefore, a post hoc power analysis was conducted after completion of the study to assess whether the sample size was adequate. Based on the PSAS score, the power analysis demonstrated a study power of 0.988. Accordingly, this high-powered study was considered to have a sufficient sample size, with 40 patients in each group and a total of 80 patients.

RESULTS

Among the patients included in the study, 55% were female, and the mean age was 48.67 ± 10.40 years (Table 1). Pneumoperitoneum was established using a Veress needle, with a maximum of two attempts in all patients. No access-related complications were observed. No significant differences were found between the two groups in terms of body mass index, age, sex, presence of chronic disease, American Society of Anesthesiologists score, smoking status, alcohol consumption, or history of previous abdominal surgery (P > 0.05). Operative time was significantly longer in the SCPI group (116.87 ± 24.22 minutes) than in the UCTI group (105.75 ± 22.40 minutes) (P = 0.036). No significant differences were observed between the groups regarding length of hospital stay (P > 0.05; Table 2).

Table 1 Characteristics of patients (n = 80), n (%)/mean ± SD.

Characteristics		Results
BMI		24.71 ± 2.8
Age		48.67 ± 10.40
Gender	Female	44 (55)
	Male	36 (45)
Number of comorbid disease	0	21 (26.2)
	1	39 (48.8)
	2 or more	20 (25)
ASA score	ASA 1	21 (26.3)
	ASA 2	59 (71.8)
Smoker	No	57 (71.3)
	Yes	23 (28.2)
Alcohol use	No	52 (65)
	Yes	28 (35)
Previous abdominal surgery	No	69 (86.2)
	Yes	11 (13.8)
Total		80 (100)

BMI: Body mass index; ASA: American Society of Anesthesiologists.

Table 2 Comparison of general characteristics of patients between intervention and control groups (n = 80), n (%)/mean ± SD.

		Intervention group, UCTI (n = 40)	Control group, SCPI (n = 40)	P value
BMI		24.6 ± 3.05	24.7 ± 2.74	0.911
Age		49.65 ± 9.3	47.70 ± 11.42	0.401
Gender	Female	20 (50)	24 (60)	0.362
	Male	20 (50)	16 (40)
Number of comorbid disease	0	9 (22.5)	12 (30)	0.652
	1	21 (52.5)	18 (45)
	2 or more	10 (25)	10 (25)
ASA score	ASA 1	9 (22.5)	12 (30)	0.442
	ASA 2	31 (77.5)	28 (70)
Smoker	No	26 (65)	31 (77.5)	0.212
	Yes	14 (35)	9 (22.5)
Alcohol use	No	27 (67.5)	25 (62.5)	0.632
	Yes	13 (32.5)	15 (37.5)
Previous abdominal surgery	No	33 (82.5)	36 (90.0)	0.332
	Yes	7 (17.5)	4 (10.0)
Total		40 (50)	40 (50)

¹Independent sample t test.

²χ² test.

BMI: Body mass index; ASA: American Society of Anesthesiologists; UCTI: Umbilical care and transumbilical incision; SCPI: Standard care and periumbilical incision.

Within the first postoperative month, superficial incisional infection in the umbilical area was observed in three patients (3.8%): Two in the SCPI group and one in the UCTI group. No significant difference was noted between the groups in terms of surgical site infection (P > 0.05). One patient (1.2%) in the SCPI group developed an incisional hernia during the first postoperative month. No significant difference was observed between the groups regarding overall complication rates (P > 0.05). At the postoperative 1-month follow-up, cosmetic satisfaction scores were significantly higher in the UCTI group (median: 9; range: 7-10) than in the SCPI group (median: 7; range: 5-9) (P < 0.001).

PSAS scores were significantly higher (indicating worse scar quality) in the SCPI group (median: 35) than in the UCTI group (median: 25) (P = 0.001). Similarly, OSAS scores were significantly higher in the SCPI group (median: 28.5) than in the UCTI group (median: 16.5) (P < 0.001). Both patients and observers rated scar outcomes as worse in the SCPI group (Table 3).

Table 3 Comparison of the distribution of operative time, surgical site infection, length of hospital stay, incisional hernia development, and cosmetic satisfaction levels between the groups, n (%)/mean ± SD/median (minimum-maximum).

Variable		Intervention group, UCTI (n = 40)	Control group, SCPI (n = 40)	P value
Operative time (minutes)		105.75 ± 22.40	116.87 ± 24.22	0.0361
Length of hospital stay (days)		1 (1-3)	1 (1-4)	0.0773
Complication (incisional hernia, SSI within 1 month)	Yes	3 (3.8)	1 (1.2)	0.6152
	No	37 (46.3)	39 (48.8)
SSI	Yes	1 (1.2)	2 (2.5)	1.0002
	No	39 (48.8)	38 (47.5)
Cosmetic satisfaction level (VAS)		9 (7-10)	7 (5-9)	< 0.0011
PSAS score		25 (15-46)	35 (15-60)	0.0013
PSAS item 7 score (patients’ overall opinion of the scar)		3 (1-5)	6 (4-8)	< 0.0013
OSAS score		16.5 (6-39)	28.5 (20-53)	< 0.0013
OSAS item 7 score (observer’s overall opinion of the scar)		3 (1-6)	5.5 (2-8)	< 0.0013

¹Independent sample t test.

²Fisher’s exact test.

³Mann Whitney U test.

SSI: Surgical site infection; VAS: Visual analog scale; PSAS: Patient scar assessment scale; OSAS: Observer scar assessment scale; UCTI: Umbilical care and transumbilical incision; SCPI: Standard care and periumbilical incision.

DISCUSSION

Periumbilical access remains the most commonly used approach for initial peritoneal entry in LC[8,12,21,22]. However, the umbilicus is considered a naturally contaminated area due to its anatomical structure and favorable conditions for bacterial colonization. Standard preoperative skin preparation may not completely eliminate umbilical microflora, raising concerns regarding infection risk when transumbilical incisions are used[12-15].

Some studies have shown that the transumbilical approach does not differ from the periumbilical approach in terms of the risk of surgical site infection[12,21]. A study comparing surgical site infection rates after transumbilical and supraumbilical incisions in laparoscopic colon surgery reported no difference between the two groups[12]. Another study demonstrated that the use of a small transverse transumbilical incision in laparoscopic colorectal surgery is unlikely to lead to surgical site infection, despite the umbilicus harboring a high bacterial load, provided that adequate infection control measures are implemented[21]. In contrast, Sharples et al[22] reported that surgical site infection developed in 28.4% of patients after laparoscopic colorectal surgery, with 82% of these infections occurring at the umbilical site. Furthermore, they noted that when the incision was made through a previously used umbilical site, combined with additional preoperative umbilical care and circumferential isolation of the umbilicus, the infection rate decreased to 11.6%. The main difference between this study and similar studies in the literature is the inclusion of only patients undergoing clean surgery, in whom contamination or other surgery-related sources of infection were not expected (patients undergoing LC with perforated, ruptured, or infected gallbladders were excluded). Therefore, if an infection occurred, the likelihood that it was related to the transumbilical approach is strengthened. In this study, within 1 month postoperatively, superficial surgical site infection at the umbilical area developed in one patient in the UCTI group and in two patients in the SCPI group. No significant difference was observed in surgical site infection rates between the two groups.

Laparoscopic surgery aims to reduce wound-related complications and improve cosmetic satisfaction[4,7,23]. As the umbilical region is a visible area, the development of an asymmetrical scar around the umbilicus due to an incision may lead to cosmetic dissatisfaction among patients[7]. In this study, patients in the UCTI group rated their scar appearance more favorably than those in the SCPI group. Similarly, at postoperative month 1, the surgeon’s assessment of scar healing was worse in patients in the SCPI group than those in the UCTI group. Moreover, patients’ overall perception of their scar was better in the UCTI group than in the SCPI group. Consistently, the overall assessment of the scar by objective evaluators (surgeon and nurse) was more favorable in the UCTI group than in the SCPI group.

In the postoperative period following a transumbilical approach, the scar located within the depth of the umbilicus becomes almost invisible[4,7,23]. Lee and Hong[7] reported that patients who underwent transumbilical incision for initial access to the peritoneal cavity in laparoscopic surgery demonstrated higher satisfaction levels than those who underwent a periumbilical approach. Consistent with the literature, the present study found that patient satisfaction was significantly higher in the UCTI group than in the SCPI group. The near invisibility of the scar after a transumbilical approach (Figure 2A) appears to be more cosmetically satisfactory for patients.

In a meta-analysis comparing transumbilical and periumbilical incisions, the transumbilical approach was recommended for initial peritoneal access in laparoscopic abdominal surgery because it provides a significant decrease in operative time[8]. Furthermore, Lee and Hong[7] reported shorter operative times in patients undergoing transumbilical incision than in those undergoing periumbilical access. Consistent with these findings, the operative time was significantly shorter in the UCTI group than in the SCPI group in the present study. All procedures were performed by an experienced hepatobiliary surgeon, indicating that operative time was unlikely to vary due to surgeon-related factors; therefore, shorter operative time may be attributed to the ease of transumbilical access and fascial closure. In this study, no significant difference was observed between the two groups in terms of length of hospital stay. Similarly, a meta-analysis reported comparable hospital stay durations following transumbilical and periumbilical approaches[8].

Data in the literature regarding the incidence of port-site hernia following laparoscopic procedures are limited and inconsistent[24-26]. Incisional hernias are among the most common long-term complications of abdominal surgery. Although incisional hernias occur less frequently after laparoscopic surgery compared with open surgery, this problem has not been completely eliminated. In a systematic review including 12 studies (n = 922), the incidence of incisional hernia after laparoscopic surgery was 0.8%[24]. In a retrospective analysis of 272 patients who underwent laparoscopic colorectal surgery, port-site hernia developed in 23.5% of patients, and 10.9% of these patients required hernia repair[26]. In the present study, incisional hernia developed within the first postoperative month in one patient (1.2%) in the SCPI group. When complication rates were compared, no significant difference was observed between the groups.

This study has some limitations, including its single-center design and the relatively small sample size, which may have influenced the results. Operative time was recorded as the total duration of LC. As all cases involved elective procedures performed by the same experienced surgeon using a standardized technique, the total operative time was considered a clinically relevant outcome reflecting overall surgical efficiency. Another limitation is the relatively short follow-up period for the assessment of incisional hernia, which was limited to 30 days and may not capture late-onset hernias.

CONCLUSION

In multiport LC, transumbilical access following appropriate umbilical care can be safely preferred over periumbilical access. Despite similar complication rates, the transumbilical approach offers shorter operative time, improved scar quality, and higher cosmetic satisfaction.