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Intraumbilical versus periumbilical incision in laparoscopic cholecystectomy: A randomized controlled trial
Accepted Manuscript Intraumbilical Versus Periumbilical Incision in Laparoscopic Cholecystectomy: A Randomised Controlled Trial Jun Suh Lee, Tae Ho Hong PII:
S1743-9191(16)30280-1
DOI:
10.1016/j.ijsu.2016.07.071
Reference:
IJSU 2960
To appear in:
International Journal of Surgery
Received Date: 31 March 2016 Revised Date:
25 June 2016
Accepted Date: 30 July 2016
Please cite this article as: Lee JS, Hong TH, Intraumbilical Versus Periumbilical Incision in Laparoscopic Cholecystectomy: A Randomised Controlled Trial, International Journal of Surgery (2016), doi: 10.1016/ j.ijsu.2016.07.071. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Intraumbilical Versus Periumbilical Incision in Laparoscopic
A Randomised Controlled Trial
Department of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic
University of Korea, Incheon, Korea 2
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Jun Suh Lee1, Tae Ho Hong2
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Cholecystectomy:
Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic
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University of Korea, Seoul, Korea
Corresponding author: Tae Ho Hong
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Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
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Tel: +82-2-2258-2876, Fax: +82-2-595-2992 e-mail: [email protected]
Running head: Initial incision in laparoscopic cholecystectomy
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Abstract Introduction: An important issue in laparoscopic surgery is initial peritoneal access. An
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intraumbilical (IU) incision may be easier and faster to place, but due to concerns about wound complications, the periumbilical (PU) incision is still often used. A prospective randomized controlled study was performed to investigate the outcomes of the IU incision
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and PU incision in laparoscopic cholecystectomy.
Methods: Study subjects were patients who received laparoscopic cholecystectomy for acute
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or chronic cholecystitis, gallbladder polyp or adenomyomatosis, or porcelain gallbladder from June 2014 to January 2015. Enrolled subjects were randomly allocated to the IU incision group or the PU incision group. Demographic data, perioperative outcomes, and the results of a cosmetic satisfaction questionnaire were analyzed.
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Results: A total of 130 subjects were analyzed (64 in the IU group, 66 in the PU group). There were no differences in patient demographics. The operation time was significantly shorter in the IU group (34.2 ± 14.6 vs 41.7 ± 21.3, P = 0.020). The cosmetic survey score
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was significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001). There was no difference in the complication rates of the two groups.
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Conclusions: The IU incision is a safe, feasible method of initial intraperitoneal access that can reduce the operation time and offer superior cosmetic effects to the patient.
Keywords: Laparoscopy; Cholecystectomy, Laparoscopic; Umbilicus
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Introduction Laparoscopic surgery is being performed widely in many different fields. The
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advantage of laparoscopic surgery has been proven for procedures such as appendectomy, cholecystectomy, hernia repair, etc.[1-3] Current issues under debate are various methods of laparoscopy, rather than the issue of open versus laparoscopic surgery. Single incision surgery,
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a type of surgery performed through a single incision that is usually placed in the umbilicus, is method being used in many fields of surgery.[4-6] Another method that has been studied is
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reduced port surgery, in which a reduced number of ports are used compared to the conventional method. Although more than one port is used, advocates of this method claim that this method can reduce complications, with comparable operative outcomes.[7, 8] There is also mini-laparoscopic surgery, in which laparoscopic instruments of a smaller caliber are used. Although the same number of ports is used, due to the smaller incisions required,
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further minimized access can be achieved.[9, 10]
The methods described above are only several of the many methods being researched today. An issue that is important in all aspects of laparoscopic surgery is initial peritoneal
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access. The first incision used by a majority of surgeons is usually a vertical incision made inside the umbilicus, or a U shaped incision made beneath or above the umbilicus. Since the
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layers of the abdominal wall converge at the umbilicus, the intraumbilical (IU) incision may be relatively easier and faster to place, and also to close. But it seems many surgeons prefer the periumbilical (PU) incision, possibly due to concerns about complications such as wound infection or umbilical hernia. The authors have reported a retrospective study comparing the outcomes of the IU 2
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incision and PU incision in laparoscopic appendectomy.[11] There were no differences in wound infection or umbilical hernia. This study was designed as a prospective randomized controlled study, studying patients on whom laparoscopic cholecystectomy was performed.
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Compared to laparoscopic appendectomy, when laparoscopic cholecystectomy is performed, the specimen sometimes requires extension of the umbilical wound. On one hand there may be less contamination of the wound, but more wound extension and manipulation may be
Materials and Methods Study design
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required. We present the methods and the results of our study.
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This prospective randomized controlled study was approved by the Institutional Review Board (IRB) of Seoul St. Mary’s Hospital (IRB protocol number: KC14EISI0149). The allocation ratio was 1:1. Randomization was performed using a random number table, in
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blocks of 5. JS Lee was in charge of generating the random allocation sequence, participant enrollment, and intervention assignment. The study period was June 2014 to January 2015.
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Study subjects were patients who received laparoscopic cholecystectomy for acute or chronic cholecystitis, gallbladder polyp or adenomyomatosis, or porcelain gallbladder during the study period. Patients who requested single port transumbilical surgery, patients in whom cooperation of other organs were performed, immunosuppressed patients, patients with a history of upper abdominal surgery, and patients converted to open surgery were excluded.
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No changes were made in the criteria after trial commencement. The primary endpoint of this study was the wound complication rate of the umbilical
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incision. The secondary endpoint was the cosmetic satisfaction score. The hypothesis was that the IU incision would not be inferior to the PU incision in terms of wound complications. There was no change in endpoint after trial commencement.
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The study was explained to the patients in detail. Written informed consent was obtained for every subject. Each patient was allocated to either the IU group or the PU group, using a
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random number table. The patients were blinded to the allocated group, and the surgeon was also blinded to the allocated group until beginning of the operation. Data collection and analysis was performed by an independent researcher.
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Outcome measurement
Demographic data such as age, sex, body mass index (BMI), comorbidity, gallbladder pathology, and cholecystitis severity were collected. The Tokyo guidelines for the
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management of acute cholecystitis (TG13) were used to assess the severity of cholecystitis.[12] Perioperative data such as operation time, estimated blood loss,
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postoperative complications, pain score, pain control medication requirement, return to diet, and postoperative hospital stay were collected. At the outpatient clinic visit scheduled one week after discharge, each patient was asked
to fill out a body image questionnaire (BIQ). The BIQ was devised by Dunker et al.[13] , and has been used to assess the patient satisfaction of the cosmetic effect of surgery. It consists of 4
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a total of ten items, asking a range of questions such as the patients’ perception of their own body, the patients’ satisfaction with the surgical scar, and the patients’ self-confidence before and after surgery. The BIQ score ranges from 0 to 44, and a higher score corresponds to a
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higher body image.
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Surgical technique
After general anesthesia, the umbilicus was prepared by removing all debris using gauze,
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cotton swabs, and alcohol. Either an IU incision or a PU incision was placed for initial intraperitoneal access, using a method described previously.[11] A 10 mm trocar was inserted, and pneumoperitoneum was achieved by carbon dioxide (CO2) insufflation, up to a pressure of 12 mmHg. The epigastric trocar was placed about 5 cm below the xiphoid process, and the
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lateral trocar was placed in the anterior axillary line, at a level slightly above the umbilicus. A grasper was inserted through the lateral trocar, the infundibulum of the gallbladder was retracted to expose the Calot’s triangle, and a working instrument inserted through the epigastric trocar was used to dissect the cystic duct and artery. After identification of the
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cystic duct and artery, the structures were ligated with clips and divided with endoscissors.
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The gallbladder was dissected off the liver bed, and placed inside a vinyl bag. The bag was removed through the initial incision. After removal of the gallbladder, the incisions were closed. In case of the IU incision, only a single full layer suture was required for closure. Skin closure or subcutaneous fat layer closure were unnecessary. Closure of the PU incision was performed in a layer-by-layer fashion.
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Statistical analysis
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Data analysis was performed using SPSS statistical package software version 20.0 for Windows (SPSS Inc., Chicago, IL, USA). Comparison of categorical variables were performed with the chi-square test of Fisher’s exact test. Comparisons of continuous
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variables were performed using Student’s t-test. All tests were two-sided, and a P value ≤
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0.05 was regarded as significant.
Results
A total of 140 patients were enrolled in the study. Seventy-one patients were allocated to the IU incision group (IU group), and 69 patients were allocated to the PU incision group (PU
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group). In the IU group, 7 patients were excluded, and 64 patients were analyzed. Among the 7 excluded patients, 5 patients were excluded due to previous upper abdominal surgery, and 2 patients were excluded due to the patient requesting single incision surgery. In the PU group,
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3 patients were excluded, and 66 patients were analyzed. All 3 patients were excluded due to
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previous upper abdominal surgery. Table 1 shows the patient demographics. There were no significant differences in age,
gender, BMI, comorbidities, pathologic findings, or cholecystitis severity between the two groups. Mean age was 52.1 ± 14.5 in the IU group, and 55.7 ± 17.4 in the PU group. The number of male subjects were 29 (45.3%) in the IU group and 36 (54.5%) in the PU group. Surgical outcomes are shown in Table 2. The operation time was significantly shorter in 6
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the IU group (34.2 ± 14.6 vs 41.7 ± 21.3, P = 0.020). There were no significant differences in estimated blood loss, start of diet, length of postoperative hospital stay, Visual Analogue Scale (VAS) score during convalescence, or required analgesic dosage. The cosmetic survey
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score was significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001).
There was no difference in the complication rates of the two groups, and there were no mortalities in any group. There were no important harms or unintended effects in any
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participants.
Discussion
Although the initial peritoneal access is an important factor in laparoscopic surgery, methods vary widely according to surgeon. Both the IU incision and the PU incision are
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being used. Most reports of single incision surgery use the IU incision.[5, 14] Not only is the IU incision easier to perform single incision surgery, but a truly ‘scarless surgery’ can be performed. Figure 1 shows the IU incision and PU incision both immediately after surgery
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and 2 weeks after surgery. The scar is less visible in the IU incision. But due to concerns over complications such as wound infection or umbilical hernia, the PU incision is still being used.
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With the advent and standardization of surgical technique, many investigators have
reported on the cosmetic effects of various kinds of surgery.[15-17] In types of surgery where the complication rate has been reduced to an acceptable rate, the cosmetic effect and the subjective satisfaction of the patient are now an important factors that is being actively researched.
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The purpose of this study was to compare the two different methods of the umbilical incision. The authors have reported a retrospective study comparing the IU and PU incisions, with no difference in complication rates. As opposed to the previous study, in which the
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subjects were treated for perforated appendicitis, the subjects of the present study were patients being treated for gallbladder disease. The reason for selecting these patients was the size of the specimen. Compared to laparoscopic appendectomy or laparoscopic hernia repair,
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the specimen being removed from the umbilicus is relatively large. Thickened gallbladder walls and large stones may result in large specimens that require extension of the wound. The
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hypothesis was that in these situations, the impact of choosing the IU or PU incision may affect the operation time, and the umbilical hernia rate.
The results of this study show a significantly shorter operation time in the IU group, compared to the PU group. (34.2 ± 14.6 min vs 41.7 ± 21.3, P = 0.020) Separate
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measurements of wound opening time or wound closing time were not measured in this study, so it is difficult to conclude that this difference is solely due to the difference in incision method. However, the most important operation time related factor in laparoscopic
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cholecystectomy is the difficulty of dissection at the Calot’s triangle. In this study, the severity of cholecystitis as measured by the Tokyo guidelines did not differ between the two
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groups. Furthermore, the majority of cases in both groups had pathologic findings of chronic cholecystitis (78.1% in the IU group, 86.4% in the PU group). In chronic cholecystitis cases, in which the surgical technique is relatively easier, the variation in operation time may be lesser. Also, surgeon expertise is an important variable. In our study, all cases were performed by a single highly-experienced surgeon (HTH). Considering these findings, the faster opening and closing time of the IU incision may have contributed to this difference. The walls of the 8
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abdominal wall converge at the umbilicus. When the incision is placed inside the umbilicus, opening the skin and the fascia directly underneath allows intraperitoneal access. Using a method we have described previously,[11] the IU incision can be closed with a single full
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layer suture. In contrast, the PU incision requires opening the skin, subcutaneous fat, and the fascia. Closing the PU incision is also more cumbersome, since the respective layers need to be closed in a layer by layer fashion. In cases where the wound needs to be extended to allow
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delivery of a large specimen, extending the PU incision can be even more difficult.
Another factor that needs to be considered is obesity. In this study, the average BMI was
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about 24 to 25. (IU group 24.4 ± 3.4 vs PU group 24.7 ± 4.0, P = 0.736) This is decidedly lower than the average BMI of the western population. But since the subjects were patients with gallbladder disease, a considerable percentage of the patients were obese. In these patients, the advantage of the IU incision was emphasized, since dissection of a thick layer of
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subcutaneous fat was unnecessary. Whereas when the PU incision was used, the skin incision often needed to be extended just to reach the fascia. An important endpoint in this study was the subjective cosmetic satisfaction of the
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patient. A BIQ devised by Dunker et al.[13] was used. This questionnaire has been used to evaluate the cosmetic effect of various procedures.[18, 19] In this study, the BIQ score was
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significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001). The discrepancy in subjective satisfaction may have been emphasized in patients with poorer wound healing, such as patients prone to keloid scars. There were no differences in the complication rates between the two groups. (4.7% vs 7.6%, P = 0.718) The incidences of the two most feared complications of the IU incision, 9
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wound infection and umbilical hernia, did not differ between the two groups. In the case of wound infection, none occurred in the IU group, and 2 cases of wound infection in the PU group were treated with conservative care in the outpatient clinic. There was no statistical
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significance. (0% vs 3.0%, P = 0.496) There were no umbilical hernias in the two groups. Antoniou et al.[20] reported that when single port totally extraperitoneal is performed through a transumbilical incision, the risk of hernia may increase. However, these findings
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may be limited to transumbilical single incision surgery, since it requires a relatively longer incision in the umbilicus. When a conventional 10 mm incision is placed in the umbilicus,
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even with occasional extension of the wound, the risk of umbilical hernia seems to be insignificant. However, regarding the umbilical hernia rate, this study has two limitations. First of all, the follow up period is relatively short. Unlike the wound infection rate, to completely rule out the occurrence of hernia, a longer follow up period would be necessary. Secondly, in some cases, the wound was extended to allow for specimen delivery. This may
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have influenced occurrence of hernia, but the wound extension rate was not documented. In conclusion, when compared to the PU incision, the IU incision is a safe, feasible
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method of initial intraperitoneal access that can reduce the operation time and offer superior
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cosmetic effects to the patient.
Disclosure Statement There was no funding for this study, and no competing financial interests exist.
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TABLE 1. Patient Demographics Demographics
IU Group
(n =
PU Group
P value
64)
(n = 66)
Age (years)
52.1 ± 14.5
55.7 ± 17.4
Male (n, %)
29 (45.3)
36 (54.5)
0.380
Body mass index (kg/m2)
24.4 ± 3.4
24.7 ± 4.0
0.736
Diabetes
8 (12.5)
12 (18.2)
0.468
Hypertension
16 (25.0)
15 (22.7)
0.838
0 (0)
0.116
Pathologic findings (n, %) Chronic cholecystitis Acute gangrenous Acute suppurative
3 (4.7)
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Coronary artery disease
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Comorbidities (n, %)
50 (78.1)
57 (86.4)
8 (12.5)
8 (12.1)
6 (9.4)
1 (1.5)
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Grade II
0.152
0.643
*Cholecystitis severity (n, %)
Grade I
0.199
3 (21.4)
11 (78.6)
3 (33.3)
6 (66.7)
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* Cholecystitis severity was classified according to the Tokyo guidelines (TG13 diagnostic
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criteria and severity grading of acute cholecystitis). IU, intraumbilical; PU, periumbilical.
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TABLE 2. Perioperative Data IU Group
PU Group
(n = 64)
(n = 66)
Operation time (min)
34.2 ± 14.6
41.7 ± 21.3
Estimated blood loss (ml)
19.3 ± 20.8
32.1 ± 61.1
0.112
Start of diet (days)
1.1 ± 0.8
1.0 ± 0.1
0.330
Hospital stay (days)
2.1 ± 0.9
2.1 ± 0.4
0.599
3.8 ± 2.0
POD#1
1.9 ± 2.0
0.020*
4.0 ± 2.2
0.615
1.6 ± 1.4
0.278
0.6 ± 0.9
0.8 ± 1.0
0.411
0.6 ± 0.8
0.8 ± 0.8
0.344
0.4 ± 0.8
0.3 ± 0.6
0.228
0.0 ± 0.1
0.1 ± 0.3
0.255
36.8 ± 5.2
33.2 ± 5.2
<0.001*
3 (4.7)
5 (7.6)
0.718
0 (0)
2 (3.0)
0.496
0 (0)
0 (0)
1.000
2 (3.1)
1 (1.5)
0.616
1 (1.6)
1 (1.5)
1.000
Hemorrhage
0 (0)
1 (1.5)
1.000
Mortality (n, %)
0 (0)
0 (0)
1.000
POD#2 Analgesic dosage required Operation day
POD#2 Cosmetic survey score Complications (n, %)
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Wound infection
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POD#1
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Operation day
P value
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VAS score
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Outcomes
Umbilical hernia
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PONV
Paralytic ileus
IU, intraumbilical; PU, periumbilical; VAS, visual analogue scale; POD, postoperative day; PONV, postoperative nausea and vomiting. 14
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Highlights
The operative results and patient satisfaction questionnaire results of the intraumbilical
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(IU) incision placed inside the umbilicus and the periumbilical (PU) incision placed below the umbilicus were analyzed.
130 patients who received laparoscopic cholecystectomy were randomly allocated in to
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either the IU or PU groups.
In the IU group, the operation time was shorter and the cosmetic survey score was higher than the PU group.
There was no difference in complication rates between the two groups.
The IU incision is a safe, feasible method that can reduce operation time.
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S1743-9191(16)30280-1
DOI:
10.1016/j.ijsu.2016.07.071
Reference:
IJSU 2960
To appear in:
International Journal of Surgery
Received Date: 31 March 2016 Revised Date:
25 June 2016
Accepted Date: 30 July 2016
Please cite this article as: Lee JS, Hong TH, Intraumbilical Versus Periumbilical Incision in Laparoscopic Cholecystectomy: A Randomised Controlled Trial, International Journal of Surgery (2016), doi: 10.1016/ j.ijsu.2016.07.071. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Intraumbilical Versus Periumbilical Incision in Laparoscopic
A Randomised Controlled Trial
Department of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic
University of Korea, Incheon, Korea 2
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1
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Jun Suh Lee1, Tae Ho Hong2
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Cholecystectomy:
Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic
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University of Korea, Seoul, Korea
Corresponding author: Tae Ho Hong
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Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
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Tel: +82-2-2258-2876, Fax: +82-2-595-2992 e-mail: [email protected]
Running head: Initial incision in laparoscopic cholecystectomy
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Abstract Introduction: An important issue in laparoscopic surgery is initial peritoneal access. An
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intraumbilical (IU) incision may be easier and faster to place, but due to concerns about wound complications, the periumbilical (PU) incision is still often used. A prospective randomized controlled study was performed to investigate the outcomes of the IU incision
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and PU incision in laparoscopic cholecystectomy.
Methods: Study subjects were patients who received laparoscopic cholecystectomy for acute
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or chronic cholecystitis, gallbladder polyp or adenomyomatosis, or porcelain gallbladder from June 2014 to January 2015. Enrolled subjects were randomly allocated to the IU incision group or the PU incision group. Demographic data, perioperative outcomes, and the results of a cosmetic satisfaction questionnaire were analyzed.
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Results: A total of 130 subjects were analyzed (64 in the IU group, 66 in the PU group). There were no differences in patient demographics. The operation time was significantly shorter in the IU group (34.2 ± 14.6 vs 41.7 ± 21.3, P = 0.020). The cosmetic survey score
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was significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001). There was no difference in the complication rates of the two groups.
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Conclusions: The IU incision is a safe, feasible method of initial intraperitoneal access that can reduce the operation time and offer superior cosmetic effects to the patient.
Keywords: Laparoscopy; Cholecystectomy, Laparoscopic; Umbilicus
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Introduction Laparoscopic surgery is being performed widely in many different fields. The
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advantage of laparoscopic surgery has been proven for procedures such as appendectomy, cholecystectomy, hernia repair, etc.[1-3] Current issues under debate are various methods of laparoscopy, rather than the issue of open versus laparoscopic surgery. Single incision surgery,
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a type of surgery performed through a single incision that is usually placed in the umbilicus, is method being used in many fields of surgery.[4-6] Another method that has been studied is
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reduced port surgery, in which a reduced number of ports are used compared to the conventional method. Although more than one port is used, advocates of this method claim that this method can reduce complications, with comparable operative outcomes.[7, 8] There is also mini-laparoscopic surgery, in which laparoscopic instruments of a smaller caliber are used. Although the same number of ports is used, due to the smaller incisions required,
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further minimized access can be achieved.[9, 10]
The methods described above are only several of the many methods being researched today. An issue that is important in all aspects of laparoscopic surgery is initial peritoneal
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access. The first incision used by a majority of surgeons is usually a vertical incision made inside the umbilicus, or a U shaped incision made beneath or above the umbilicus. Since the
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layers of the abdominal wall converge at the umbilicus, the intraumbilical (IU) incision may be relatively easier and faster to place, and also to close. But it seems many surgeons prefer the periumbilical (PU) incision, possibly due to concerns about complications such as wound infection or umbilical hernia. The authors have reported a retrospective study comparing the outcomes of the IU 2
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incision and PU incision in laparoscopic appendectomy.[11] There were no differences in wound infection or umbilical hernia. This study was designed as a prospective randomized controlled study, studying patients on whom laparoscopic cholecystectomy was performed.
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Compared to laparoscopic appendectomy, when laparoscopic cholecystectomy is performed, the specimen sometimes requires extension of the umbilical wound. On one hand there may be less contamination of the wound, but more wound extension and manipulation may be
Materials and Methods Study design
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required. We present the methods and the results of our study.
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This prospective randomized controlled study was approved by the Institutional Review Board (IRB) of Seoul St. Mary’s Hospital (IRB protocol number: KC14EISI0149). The allocation ratio was 1:1. Randomization was performed using a random number table, in
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blocks of 5. JS Lee was in charge of generating the random allocation sequence, participant enrollment, and intervention assignment. The study period was June 2014 to January 2015.
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Study subjects were patients who received laparoscopic cholecystectomy for acute or chronic cholecystitis, gallbladder polyp or adenomyomatosis, or porcelain gallbladder during the study period. Patients who requested single port transumbilical surgery, patients in whom cooperation of other organs were performed, immunosuppressed patients, patients with a history of upper abdominal surgery, and patients converted to open surgery were excluded.
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No changes were made in the criteria after trial commencement. The primary endpoint of this study was the wound complication rate of the umbilical
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incision. The secondary endpoint was the cosmetic satisfaction score. The hypothesis was that the IU incision would not be inferior to the PU incision in terms of wound complications. There was no change in endpoint after trial commencement.
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The study was explained to the patients in detail. Written informed consent was obtained for every subject. Each patient was allocated to either the IU group or the PU group, using a
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random number table. The patients were blinded to the allocated group, and the surgeon was also blinded to the allocated group until beginning of the operation. Data collection and analysis was performed by an independent researcher.
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Outcome measurement
Demographic data such as age, sex, body mass index (BMI), comorbidity, gallbladder pathology, and cholecystitis severity were collected. The Tokyo guidelines for the
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management of acute cholecystitis (TG13) were used to assess the severity of cholecystitis.[12] Perioperative data such as operation time, estimated blood loss,
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postoperative complications, pain score, pain control medication requirement, return to diet, and postoperative hospital stay were collected. At the outpatient clinic visit scheduled one week after discharge, each patient was asked
to fill out a body image questionnaire (BIQ). The BIQ was devised by Dunker et al.[13] , and has been used to assess the patient satisfaction of the cosmetic effect of surgery. It consists of 4
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a total of ten items, asking a range of questions such as the patients’ perception of their own body, the patients’ satisfaction with the surgical scar, and the patients’ self-confidence before and after surgery. The BIQ score ranges from 0 to 44, and a higher score corresponds to a
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higher body image.
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Surgical technique
After general anesthesia, the umbilicus was prepared by removing all debris using gauze,
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cotton swabs, and alcohol. Either an IU incision or a PU incision was placed for initial intraperitoneal access, using a method described previously.[11] A 10 mm trocar was inserted, and pneumoperitoneum was achieved by carbon dioxide (CO2) insufflation, up to a pressure of 12 mmHg. The epigastric trocar was placed about 5 cm below the xiphoid process, and the
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lateral trocar was placed in the anterior axillary line, at a level slightly above the umbilicus. A grasper was inserted through the lateral trocar, the infundibulum of the gallbladder was retracted to expose the Calot’s triangle, and a working instrument inserted through the epigastric trocar was used to dissect the cystic duct and artery. After identification of the
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cystic duct and artery, the structures were ligated with clips and divided with endoscissors.
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The gallbladder was dissected off the liver bed, and placed inside a vinyl bag. The bag was removed through the initial incision. After removal of the gallbladder, the incisions were closed. In case of the IU incision, only a single full layer suture was required for closure. Skin closure or subcutaneous fat layer closure were unnecessary. Closure of the PU incision was performed in a layer-by-layer fashion.
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Statistical analysis
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Data analysis was performed using SPSS statistical package software version 20.0 for Windows (SPSS Inc., Chicago, IL, USA). Comparison of categorical variables were performed with the chi-square test of Fisher’s exact test. Comparisons of continuous
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variables were performed using Student’s t-test. All tests were two-sided, and a P value ≤
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0.05 was regarded as significant.
Results
A total of 140 patients were enrolled in the study. Seventy-one patients were allocated to the IU incision group (IU group), and 69 patients were allocated to the PU incision group (PU
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group). In the IU group, 7 patients were excluded, and 64 patients were analyzed. Among the 7 excluded patients, 5 patients were excluded due to previous upper abdominal surgery, and 2 patients were excluded due to the patient requesting single incision surgery. In the PU group,
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3 patients were excluded, and 66 patients were analyzed. All 3 patients were excluded due to
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previous upper abdominal surgery. Table 1 shows the patient demographics. There were no significant differences in age,
gender, BMI, comorbidities, pathologic findings, or cholecystitis severity between the two groups. Mean age was 52.1 ± 14.5 in the IU group, and 55.7 ± 17.4 in the PU group. The number of male subjects were 29 (45.3%) in the IU group and 36 (54.5%) in the PU group. Surgical outcomes are shown in Table 2. The operation time was significantly shorter in 6
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the IU group (34.2 ± 14.6 vs 41.7 ± 21.3, P = 0.020). There were no significant differences in estimated blood loss, start of diet, length of postoperative hospital stay, Visual Analogue Scale (VAS) score during convalescence, or required analgesic dosage. The cosmetic survey
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score was significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001).
There was no difference in the complication rates of the two groups, and there were no mortalities in any group. There were no important harms or unintended effects in any
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participants.
Discussion
Although the initial peritoneal access is an important factor in laparoscopic surgery, methods vary widely according to surgeon. Both the IU incision and the PU incision are
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being used. Most reports of single incision surgery use the IU incision.[5, 14] Not only is the IU incision easier to perform single incision surgery, but a truly ‘scarless surgery’ can be performed. Figure 1 shows the IU incision and PU incision both immediately after surgery
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and 2 weeks after surgery. The scar is less visible in the IU incision. But due to concerns over complications such as wound infection or umbilical hernia, the PU incision is still being used.
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With the advent and standardization of surgical technique, many investigators have
reported on the cosmetic effects of various kinds of surgery.[15-17] In types of surgery where the complication rate has been reduced to an acceptable rate, the cosmetic effect and the subjective satisfaction of the patient are now an important factors that is being actively researched.
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The purpose of this study was to compare the two different methods of the umbilical incision. The authors have reported a retrospective study comparing the IU and PU incisions, with no difference in complication rates. As opposed to the previous study, in which the
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subjects were treated for perforated appendicitis, the subjects of the present study were patients being treated for gallbladder disease. The reason for selecting these patients was the size of the specimen. Compared to laparoscopic appendectomy or laparoscopic hernia repair,
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the specimen being removed from the umbilicus is relatively large. Thickened gallbladder walls and large stones may result in large specimens that require extension of the wound. The
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hypothesis was that in these situations, the impact of choosing the IU or PU incision may affect the operation time, and the umbilical hernia rate.
The results of this study show a significantly shorter operation time in the IU group, compared to the PU group. (34.2 ± 14.6 min vs 41.7 ± 21.3, P = 0.020) Separate
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measurements of wound opening time or wound closing time were not measured in this study, so it is difficult to conclude that this difference is solely due to the difference in incision method. However, the most important operation time related factor in laparoscopic
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cholecystectomy is the difficulty of dissection at the Calot’s triangle. In this study, the severity of cholecystitis as measured by the Tokyo guidelines did not differ between the two
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groups. Furthermore, the majority of cases in both groups had pathologic findings of chronic cholecystitis (78.1% in the IU group, 86.4% in the PU group). In chronic cholecystitis cases, in which the surgical technique is relatively easier, the variation in operation time may be lesser. Also, surgeon expertise is an important variable. In our study, all cases were performed by a single highly-experienced surgeon (HTH). Considering these findings, the faster opening and closing time of the IU incision may have contributed to this difference. The walls of the 8
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abdominal wall converge at the umbilicus. When the incision is placed inside the umbilicus, opening the skin and the fascia directly underneath allows intraperitoneal access. Using a method we have described previously,[11] the IU incision can be closed with a single full
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layer suture. In contrast, the PU incision requires opening the skin, subcutaneous fat, and the fascia. Closing the PU incision is also more cumbersome, since the respective layers need to be closed in a layer by layer fashion. In cases where the wound needs to be extended to allow
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delivery of a large specimen, extending the PU incision can be even more difficult.
Another factor that needs to be considered is obesity. In this study, the average BMI was
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about 24 to 25. (IU group 24.4 ± 3.4 vs PU group 24.7 ± 4.0, P = 0.736) This is decidedly lower than the average BMI of the western population. But since the subjects were patients with gallbladder disease, a considerable percentage of the patients were obese. In these patients, the advantage of the IU incision was emphasized, since dissection of a thick layer of
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subcutaneous fat was unnecessary. Whereas when the PU incision was used, the skin incision often needed to be extended just to reach the fascia. An important endpoint in this study was the subjective cosmetic satisfaction of the
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patient. A BIQ devised by Dunker et al.[13] was used. This questionnaire has been used to evaluate the cosmetic effect of various procedures.[18, 19] In this study, the BIQ score was
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significantly higher in the IU group (36.8 ± 5.2 vs 33.2 ± 5.2, P < 0.001). The discrepancy in subjective satisfaction may have been emphasized in patients with poorer wound healing, such as patients prone to keloid scars. There were no differences in the complication rates between the two groups. (4.7% vs 7.6%, P = 0.718) The incidences of the two most feared complications of the IU incision, 9
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wound infection and umbilical hernia, did not differ between the two groups. In the case of wound infection, none occurred in the IU group, and 2 cases of wound infection in the PU group were treated with conservative care in the outpatient clinic. There was no statistical
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significance. (0% vs 3.0%, P = 0.496) There were no umbilical hernias in the two groups. Antoniou et al.[20] reported that when single port totally extraperitoneal is performed through a transumbilical incision, the risk of hernia may increase. However, these findings
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may be limited to transumbilical single incision surgery, since it requires a relatively longer incision in the umbilicus. When a conventional 10 mm incision is placed in the umbilicus,
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even with occasional extension of the wound, the risk of umbilical hernia seems to be insignificant. However, regarding the umbilical hernia rate, this study has two limitations. First of all, the follow up period is relatively short. Unlike the wound infection rate, to completely rule out the occurrence of hernia, a longer follow up period would be necessary. Secondly, in some cases, the wound was extended to allow for specimen delivery. This may
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have influenced occurrence of hernia, but the wound extension rate was not documented. In conclusion, when compared to the PU incision, the IU incision is a safe, feasible
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method of initial intraperitoneal access that can reduce the operation time and offer superior
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cosmetic effects to the patient.
Disclosure Statement There was no funding for this study, and no competing financial interests exist.
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TABLE 1. Patient Demographics Demographics
IU Group
(n =
PU Group
P value
64)
(n = 66)
Age (years)
52.1 ± 14.5
55.7 ± 17.4
Male (n, %)
29 (45.3)
36 (54.5)
0.380
Body mass index (kg/m2)
24.4 ± 3.4
24.7 ± 4.0
0.736
Diabetes
8 (12.5)
12 (18.2)
0.468
Hypertension
16 (25.0)
15 (22.7)
0.838
0 (0)
0.116
Pathologic findings (n, %) Chronic cholecystitis Acute gangrenous Acute suppurative
3 (4.7)
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Coronary artery disease
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Comorbidities (n, %)
50 (78.1)
57 (86.4)
8 (12.5)
8 (12.1)
6 (9.4)
1 (1.5)
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Grade II
0.152
0.643
*Cholecystitis severity (n, %)
Grade I
0.199
3 (21.4)
11 (78.6)
3 (33.3)
6 (66.7)
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* Cholecystitis severity was classified according to the Tokyo guidelines (TG13 diagnostic
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criteria and severity grading of acute cholecystitis). IU, intraumbilical; PU, periumbilical.
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TABLE 2. Perioperative Data IU Group
PU Group
(n = 64)
(n = 66)
Operation time (min)
34.2 ± 14.6
41.7 ± 21.3
Estimated blood loss (ml)
19.3 ± 20.8
32.1 ± 61.1
0.112
Start of diet (days)
1.1 ± 0.8
1.0 ± 0.1
0.330
Hospital stay (days)
2.1 ± 0.9
2.1 ± 0.4
0.599
3.8 ± 2.0
POD#1
1.9 ± 2.0
0.020*
4.0 ± 2.2
0.615
1.6 ± 1.4
0.278
0.6 ± 0.9
0.8 ± 1.0
0.411
0.6 ± 0.8
0.8 ± 0.8
0.344
0.4 ± 0.8
0.3 ± 0.6
0.228
0.0 ± 0.1
0.1 ± 0.3
0.255
36.8 ± 5.2
33.2 ± 5.2
<0.001*
3 (4.7)
5 (7.6)
0.718
0 (0)
2 (3.0)
0.496
0 (0)
0 (0)
1.000
2 (3.1)
1 (1.5)
0.616
1 (1.6)
1 (1.5)
1.000
Hemorrhage
0 (0)
1 (1.5)
1.000
Mortality (n, %)
0 (0)
0 (0)
1.000
POD#2 Analgesic dosage required Operation day
POD#2 Cosmetic survey score Complications (n, %)
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Wound infection
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POD#1
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Operation day
P value
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VAS score
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Outcomes
Umbilical hernia
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PONV
Paralytic ileus
IU, intraumbilical; PU, periumbilical; VAS, visual analogue scale; POD, postoperative day; PONV, postoperative nausea and vomiting. 14
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Highlights
The operative results and patient satisfaction questionnaire results of the intraumbilical
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(IU) incision placed inside the umbilicus and the periumbilical (PU) incision placed below the umbilicus were analyzed.
130 patients who received laparoscopic cholecystectomy were randomly allocated in to
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either the IU or PU groups.
In the IU group, the operation time was shorter and the cosmetic survey score was higher than the PU group.
There was no difference in complication rates between the two groups.
The IU incision is a safe, feasible method that can reduce operation time.
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