Incisional Hernia Rate May Increase After Single-Port Cholecystectomy

Introduction

Since its introduction in surgical practice, laparoscopic cholecystectomy has become the gold standard, and now it is one of the safest procedures of general surgery. Although laparoscopic cholecystectomy has a strong acceptance, many surgeons have attempted to improve cosmetic results and postoperative recovery further through reductions in the size and number of incisions.

Single-incision laparoscopic surgery was initially described as early as 1992 by Pelosi and Pelosi, ¹ who performed a laparoscopic appendectomy. Single-incision laparoscopic cholecystectomy was one of the first single-incision laparoscopic procedures. Although studies have shown the single-incision laparoscopic cholecystectomy to be feasible and safe,^2–7 there were potential pitfalls including higher cost and complications, especially port-site hernia (PSH), associated with the single-incision techniques.^8,9 The larger fascial incision for a single-port laparoscopic device may lead to an increased herniation risk. ¹⁰ The PSH is a serious complication in single-incision laparoscopic cholecystectomy because of the requirement of further surgery. Up to now, only a few cases of incisional hernia after single-incision laparoscopic cholecystectomy have been reported,^8,11,12 but in a recently published study, the umbilical hernia rate was reported as 2.4% after single-incision surgery. ¹³ The questions to be answered are “What is the risk of single-port cholecystectomy?” and “What is the impact of single-port cholecystectomy on hospital costs?” We attempt to answer these questions in this retrospective study, where we evaluated single-port cholecystectomy and traditional four-port cholecystectomy with respect to perioperative outcomes, hospital costs, and postoperative complications.

Patients and Methods

Consecutive patients who underwent single-port cholecystectomy or traditional four-port laparoscopic cholecystectomy between January 2010 to March 2011 were retrospectively evaluated. Management of patients with symptomatic gallbladder disease was performed according to institutional guidelines. Preoperatively, all patients with symptomatic gallbladder disease were examined by an expert radiologist with ultrasonography. Patients without signs of cholestasis underwent cholecystectomy. Patients with suspected common bile duct stones were candidates for magnetic resonance imaging-cholangiography. Patients with common bile duct stones were treated by endoscopic retrograde cholangiopancreatography prior to surgery. Intraoperative laparoscopic ultrasonography by using the BK Pro Focus Type 2202^® (B-K Medical, Herlev, Denmark) was our preferred technique for the evaluation of the common bile duct. The type of cholecystectomy to be performed was primarily selected according to patient demand. If the patient did not have a request, the surgeons decided the type of cholecystectomy, and no preference criterion was used for the surgical procedure to be undertaken. The decision was based on personal experience and subjective estimation of the responsible surgeon.

After institutional review board approval, the institution's database was used to screen for patients. Patients' data were obtained from hospital charts, clinic charts, and operative reports. Additional data were obtained from the hospital billing and admission–discharge databases. The data included demographics, American Society of Anesthesiologists (ASA) class, body mass index (BMI), diagnostic data, and operative information such as operative time (defined as the time from after placement of the port or trocars to removal of the gallbladder from the abdomen), rate of conversion to open procedure, and addition of more ports in single-port cholecystectomy cases. Outcomes such as complications, postoperative hospital stay (defined as the time from the postanesthesia care unit until discharge from the hospital), and the hospital costs also were obtained. Hospital costs were calculated from the start of the surgical procedure through discharge. Prior to discharge, each patient was required to tolerate liquids with adequate pain control with oral medication. Discharge was determined by the responsible surgeon following first morning rounds on postoperative Day 1. Patients were re-examined at 2 and 4 weeks postoperatively. All patients underwent a thorough physical examination at the follow-up visits. After the first month, patients were contacted by phone at 2-month intervals and asked whether they had any problems. Finally, all patients were interviewed by phone in January 2012. Patients who complained of a bulging or discomfort at the trocar or port site during the phone interview were re-examined at the outpatient department. All patients underwent a thorough physical examination, but examination of the trocar or port site with ultrasonography was only performed in the presence of suspected herniation.

The standard nondisposable hand instruments and a suction irrigator device were used for both types of cases. The disposable instruments opened for the laparoscopic cholecystectomy were two 5-mm ports and two 11-mm ports. The disposable instruments opened for the single-port cholecystectomy were a SILS™ Port (Covidien) and a roticulating grasper.

We had already performed single-incision laparoscopic surgery including cholecystectomy before January 2010. However, these patients were not enrolled in this study because different port devices (ASC Triport™; Advanced Surgical Concepts) and different access techniques (transumbilical multiport puncture) were used.

For single-port cholecystectomy, patients were placed in the “French position,” with the surgeon positioned between the patients' legs and the surgeon guiding the camera on the left site and the monitor at the right shoulder. Skin and subcutaneous tissues were passed with a 2.0-cm transverse incision from the umblicus. The fascia was slinged with notched clamps, and the abdomen was entered with a transverse fascia incision. A SILS Port was placed in the incision, and pneumoperitoneum was established. The abdomen was entered above the specific port with two 5-mm and one 10-mm trocars. A 5-mm 30° optic was used. The infundibulum was retracted laterally, a critical view of safety was achieved, and then dissection of the triangle of Calot was performed. Based on our experience, the use of a 30° laparoscope with an experienced camera operator makes visualization of Calot's triangle possible. The artery and cystic duct were clipped with a medium clip. The gallbladder was excised by hook cautery and removed from the incision line. The fascial defect was closed with a Prolene™ (Ethicon) loop. The skin is sutured with a Vicryl™ (Ethicon) rapid intradermic suture that does not require removal.

For traditional laparoscopic cholecystectomy, the surgeon was positioned to the left of the patient, with the surgeon guiding the camera on the left site and the monitor at the right shoulder. Laparoscopic cholecystectomy was performed using a four-trocar technique. Pneumoperitoneum was established either by puncture in the Veress technique or in the setting of previous abdominal surgery by the open Hasson approach. A 10-mm 30° optic was used. The critical view was achieved by cephelad fundal and lateral infundibular retraction. The triangle of Calot was dissected before ligation of the cystic duct and artery. The artery and cystic duct were clipped with a medium clip from a 11-mm trocar. The gallbladder was excised by hook cautery and removed from the subxiphoidal incision. At the subumbilical port site, the fascia was not routinely closed.

Results

During the study period, 163 patients underwent cholecystectomy. Of the 163 patients, 111 underwent laparoscopic cholecystectomy, and 52 underwent single-port cholecystectomy. The mean follow-up period was 17.8±4.9 months for patients who underwent laparoscopic cholecystectomy and 15.9±4.7 months for patients who underwent single-port cholecystectomy (P=.494). Demographic and preoperative characteristics of the patient are shown in Table 1. There was a statistically significant difference between the two patient groups regarding age: the mean age of the patients was 55.8±13.8 years in the laparoscopic cholecystectomy group and 48.7±12.7 years in the single-port cholecystectomy group (P=.002). There was no statistically significant difference in BMI or gender distribution between the two groups. Also, the two groups did not different significantly in terms of previous abdominal surgeries, ASA class, and preoperative diagnosis.

The operative features of the two groups are shown in Table 2. None of the patients received intraoperative cholangiography. There were no differences in operative time, postoperative hospital stay, and conversion to open surgery. The mean operative time was 26±14 minutes in the laparoscopic cholecystectomy group and 31±13 minutes in the single-port cholecystectomy group (P=.112). The postoperative hospital stay was not different between the two groups (1.7±1 day in laparoscopic cholecystectomy versus 1.6±1.1 day in single-port cholecystectomy, P=.416). Conversion to open surgery was comparable between the two groups (P=.921). In 1 patient with acute cholecystitis, the single-port cholecystectomy procedure was converted to laparoscopic cholecystectomy and subsequently to open cholecystectomy. In 2 patients, laparoscopic cholecystectomy was converted to open surgery because of the impossibility of performing laparoscopic dissection: 1 of these patients had acute cholecystitis, and the other had a gallbladder-duodenal fistula. The hospital costs were significantly different between the laparoscopic cholecystectomy and single-port cholecystectomy patients. The mean hospital cost of the patients was 1537±462 Turkish liras for the laparoscopic cholecystectomy group and 2372±366 Turkish liras for the single-port cholecystectomy group (P=.001); therefore the relative cost is 1.54.

We observed no major complication such as bile leak or bile duct injury during the study period. The frequency and severity of wound infection were similar in the single-port cholecystectomy (2 cases) and laparoscopic cholecystectomy (4 cases) groups. The patients who experienced wound infection required oral antibiotic treatment. In the laparoscopic cholecystectomy group, there was one urinary tract infection, which was treated with a course of oral antibiotics. In another patient undergoing laparoscopic cholecystectomy who presented with a slight elevation of liver enzymes, a common bile duct stone was diagnosed postoperatively; the stone was removed by endoscopic papillotomy without further complications. Two patients (1.8%) in the laparoscopic cholecystectomy group experienced trocar-site hernia (TSH), and 3 patients (5.8%) in the single-port cholecystectomy group experienced PSH (Table 3).

Both TSHs were located in the umbilicus area, where the 11-mm trocar was placed. One of the patients was a 65-year-old, obese, diabetic man. He underwent laparoscopic cholecystectomy and experienced wound infection at the umbilical trocar entrance. The skin suture was removed because of infection, the wound was left to heal open, and the patient was treated with a course of oral antibiotics. The second TSH in the laparoscopic cholecystectomy group occurred in a 27-year-old female patient with no significant risk factor.

All three of the PSHs in the single-port cholecystectomy group occurred in female patients and were located in the umbilicus area. Of these patients, a 61-year-old woman had chronic obstructive pulmonary disease; the remaining 2 patients had no risk factor for development of PSH. The time that elapsed between operation and herniation was less than 6 months in both groups (Table 4). All of our patients with TSH or PSH presented a bulging at the trocar or port site. The diagnosis of a hernia was confirmed by ultrasound, and patients underwent elective hernia repair (Fig. 1).

OPEN IN VIEWER

FIG. 1.

Port-site hernia after single-port cholecystectomy in a 61-year-old female patient: (A) incision scar of previous operation; (B) the sac of the hernia containing omentum; and (C) the hernia was repaired using mesh.

Discussion

The principal findings of this study are that single-port cholecystectomy is associated with high hospital cost and high PSH rate when compared with traditional laparoscopic cholecystectomy.

Surgeons should understand and verify the risks and benefits associated with new procedures so as not to lead to an unnecessary increase in hospital costs. New surgical techniques must be supported by strong evidence to demonstrate their risk and benefits to the patient. The differences in operative time, length of hospital stay, and pain control between single-incision laparoscopic cholecystectomy and laparoscopic cholecystectomy are well investigated by previous studies.^4–7,9,14 The reduced risk for wound infection, faster recovery, less postoperative pain, and improved cosmesis were proposed clinical benefits of single-port cholecystectomy. However, most of them have not been supported by clinical trials.^9–11,15

In this study, we have attempted to evaluate single-port cholecystectomy and traditional four-port cholecystectomy with respect to perioperative outcomes, hospital cost, and postoperative complications. But, there are several limitations of this study. There was the risk of bias because the study was retrospective. The study groups were not randomized. The choice of surgical technique to be used was based on subjective estimation of the responsible surgeon and patients' demands. These limitations should be kept in mind while interpreting study results.

Analysis of patient demographic characteristics demonstrated that patients undergoing laparoscopic cholecystectomy were significantly older than patients undergoing single-port cholecystectomy. Among younger people, patients may demand single-port cholecystectomy because of cosmetic concerns. The two groups were not different significantly in terms of BMI, gender distribution, previous abdominal surgeries, ASA class, and preoperative diagnosis. Although mean BMI was 28.4±5.8 kg/m², single-port cholecystectomy was performed successfully in patients with BMIs ranging from 21 to 43 kg/m². We think obesity is not a contraindication to this technique. The placement of the port device may be time consuming in obese patients. In this study, operative time was defined as the time from after placement of the port to removal of the gallbladder out of the abdomen; thus the mean operative time was not affected. Also, 25% of the patients in the single-port cholecystectomy group had undergone previous abdominal surgery; this finding indicates that previous abdominal surgery is not a contraindication to single-port cholecystectomy.

There were no differences between the two groups in term of conversion to open surgery, postoperative hospital stay, and operative time. A review and meta-analysis of seven randomized controlled studies comparing the two techniques showed that the length of hospital stay was not different between the groups. ¹⁵ The majority of the literature reported a lengthy operative time for single-incision laparoscopic cholecystectomy,^4–7,15 but the reported operative time is similar to that for conventional laparoscopy in a small number of studies.^16,17 Studies have demonstrated that as surgeons gain more experience with single-incision surgical procedures, the operating time decreases.^5,6,18 According to Qiu et al., ¹⁹ the learning curve in single-incision laparoscopic cholecystectomy is short, and after the first 20 cases, the training phase was almost complete. Our study surgeons are experienced in single-incision laparoscopic surgery. Therefore, operative times of the two groups were found to be similar in our study.

Postoperative complications occurred in both surgical groups. Although we did not observe major complications such as bile leak or bile duct injury, the result of this study is inadequate to detect significant differences in rare complications. In the laparoscopic cholecystectomy group, there were 4 (3.6%) cases of wound infection, 1 (0.9%) retained bile duct stone requiring endoscopic retrograde cholangiopancreatography extraction, and 1 (0.9%) case of urinary tract infection. Postoperative complications in the single-port cholecystectomy group included 2 (3.8%) cases of wound infection.

All available literature has concluded that single-incision laparoscopic cholecystectomy is a safe operation^2–7,9,12 but to not forget that the umbilical incision is bigger than the laparoscopic cholecystectomy incision to accommodate the special port device. Essentially a larger transumbilical incision is more likely to increase the incidence of incisional hernias.^10,12,20 The letter to the editor of Navarra et al. ²¹ suggests that the single large umbilical incision may lead a higher incidence of umbilical hernias.

After review of 29 studies, which included a total of 1166 single-incision laparoscopic cholecystectomy procedures, the incisional hernia rate was reported as 0.09% (in 1 of the 1166 patients). ⁷ The robustness of this conclusion remains open to debate. Follow-up is poorly reported in many studies, and for conclusive evaluation of herniation, current follow-up of patients who underwent single-incision laparoscopic surgery is limited, and an increasing incidence after every year of follow-up might be observed. In studies with accumulated data and experience of many years, the incidence of TSH was 0.2%–5.2% for laparoscopic cholecystectomy.^22,23 That the incidence of incisional hernia after single-port cholecystectomy would be much less than after laparoscopic cholecystectomy is not plausible.

To date, only a few cases of incisional hernia after single-incision laparoscopic cholecystectomy have been published.^8,11,12 One patient experienced an incarcerated Richter's hernia after single-incision laparoscopic cholecystectomy in the series of Romanelli et al. ¹² The second reported PSH after single-incision laparoscopic cholecystectomy occurred in a patient with ascites. ¹¹ Recently, Krajinovic et al. ⁸ reported a case of PSH after single-port cholecystectomy in a patient who had no significant risk factor. Finally, the umbilical hernia rate was reported as 2.4% in women who underwent single-incision surgery for a gynecologic indication. ¹³

In our series, the incidence of incisional hernia was higher in the single-port cholecystectomy group. Two patients (1.8%) in the laparoscopic cholecystectomy group experienced TSH. The herniation rate after laparoscopic cholecystectomy is comparable to others reported in the literature.^10,22 Three patients (5.8%) in the single-port cholecystectomy group experienced PSH. To our knowledge, this is the highest rate reported in the literature.

Azurin et al. ²⁴ reported that 95% of TSHs occurred in patients with co-morbidities such as diabetes mellitus and obesity. In our single-port cholecystectomy group, one of the patients who experienced PSH had chronic obstructive pulmonary disease; the remaining 2 patients had no risk factor for herniation. The only factor that may be responsible for herniation is inherent risk of incision to accommodate the single-port device. The extension of the umbilical fascial defect for removing the gallbladder from the abdomen is the factor predisposing the development of a hernia. ²⁵ The single-port device already necessitates a larger fascial incision for insertion.

Up to now, a few studies comparing cost for single-incision laparoscopic cholecystectomy and traditional laparoscopic cholecystectomy have been reported in the literature. Joseph et al. ⁴ compared these two technique in a retrospective study. The single-incision multipuncture technique was performed by using conventional laparoscopic instrumentation and inexpensive low-profile trocars in their study. They did not observe any difference in hospital costs. Bower and Love ²⁶ also performed the single-incision multipuncture technique. Nondisposable and disposable instruments that were used at the operations are clearly defined in their study. They stated that the cost is not significantly different between two techniques when standard materials are used. Chang et al. ⁹ performed single-port cholecystectomy by using the SILS Port; they showed that the cost of single-port cholecystectomy is higher than that of laparoscopic cholecystectomy because of use of the special umbilical port. We have shown that the cost for single-port cholecystectomy is significantly higher than that of laparoscopic cholecystectomy. We have used equal instruments in patients undergoing operation with the same surgical technique. The operative time and length of hospital stay were not different between the two groups. Therefore, we think that usage of the special umbilical port and roticulating grasper leads to the difference of costs. But, special umbilical ports have become indispensable when single-incision surgery is performed because single-incision laparoscopic surgery is associated with significant technical difficulties, including poor ergonomics, lack of triangulation, and multiple collisions. According to our experience, these technical difficulties is more prominent in the multipuncture technique. Additionally, maintaining the pneumoperitoneum is difficult because of proximity of the trocars. Special umbilical port devices and the roticulating grasper help to maximize the surgeon's ability to manipulate instruments and to provide triangulation.

This retrospective study comparing single-port cholecystectomy and traditional laparoscopic cholecystectomy did not demonstrate any statistically significant difference in operative time, length of hospital stay, and conversion to open surgery. Improved cosmesis and patient satisfaction were the proven benefits of single-incision laparoscopic cholecystectomy, which have been demonstrated by the literature. Single-port cholecystectomy is not as revolutionary a concept as traditional laparoscopic cholecystectomy. If we remember what happened in the past, we recognize that the transition from open cholecystectomy to laparoscopic cholecystectomy was associated with significant patient-related benefits.

The main findings of this study are the following: (1) Although single-port cholecystectomy seems to be a feasible surgical technique, it is not superior over the traditional laparoscopic cholecystectomy. (2) Single-port cholecystectomy has a higher cost than laparoscopic cholecystectomy. (3) Incisional hernia after single-port cholecystectomy is more frequent than reported in the current literature.