Laparoscopic Cholecystectomy: Evaluating a Protocol for Acute Complex Stone Cholecystitis

Laparoscopic cholecystectomy (LC) for acute cholecystitis has evolved over the past 3 decades. Acute cholecystitis was once considered a contraindication for LC [1,2]. Unfavorable factors such as edema, necrosis, and hypervascularization often led to complications and/or conversion to open cholecystectomy. Greater comfort with laparoscopy, technological advances, and better quality ancillary patient care have led experts to recommend early LC for the treatment of acute gallstone cholecystitis (ALC) [2,3].

Standardization of surgical techniques, meticulous dissection to achieve critical vision safety (VCS), and the use of blunt dissection have all been reported to minimize complications as well as the conversion rate [4,5] . However, even today, nihilism and fear of complications in CAL deter many surgeons from intervening early. There is a tendency to wait for resolution of inflammation/open cholecystectomy in favor of performing an initial LC.

The authors of this work work in a tertiary reference center for medical and surgical specialties. They diagnose and classify the severity of CAL according to the Tokyo Guidelines, where the mild form (Grade 1) refers to acute cholecystitis in healthy patients, with mild inflammatory changes in the gallbladder (BV), fever and/or or elevated white blood cell (RGB) count, and no organ dysfunction; moderate (Grade 2) to cholecystitis associated with high GBR (> 18,000/mm3), painful palpable mass in the right hypochondrium, discomfort > 72 hours, or signs of marked inflammation (gangrenous or emphysematous cholecystitis, pericholecystitis or liver abscess, peritonitis biliary) and severe (Grade 3) to cholecystitis with concomitant systemic organic dysfunction [6,7].

They designed a protocol consisting of 7 intraoperative safety steps for CAL. Moderate and severe CAL were considered together as “complex CAL” (CALC). It is well known that these patients present special technical challenges in management, due to the severity of the local inflammation, or the associated organ dysfunction [3,8].

The authors designed an observational and prospective study to evaluate the usefulness and safety of an established protocol and intraoperative steps, regardless of the time of intervention, to achieve SVC, minimize the incidence of subtotal cholecystectomy, bile duct injury , and conversion to open surgery, during LC for CALC.

The recruitment period of the study lasted from 2008 to 2018. Permission was obtained from the Institutional Ethics Committee prior to data collection and analysis (JH/5/15/Surg/Edi/2008).

Patients were diagnosed with CAL based on clinical examination (e.g., fever accompanied by right upper quadrant pain, Murphy sign), laboratory tests (elevated RGB and C-reactive protein), and radiological findings (e.g., GB with thickened wall, pericholecystic fluid, overdistended GB with stone impacted in the neck, gap in the continuity of the gallbladder wall or presence of subdiaphragmatic collection suggestive of gangrenous cholecystitis).

All patients with CAL were stratified according to the Tokyo Guidelines (2007/2013) into: Grade I (mild), Grade II (moderate) or Grade III (severe) cholecystitis. Only those with moderate and severe CAL were included in this study. Mild CAL, BV mucocele, acalculous cholecystitis, and BV malignancy were excluded.

After segregation, patients eligible for surgical intervention were offered an initial LC, regardless of the time of symptom onset. Patients with hypotension, sepsis, altered liver or kidney function parameters, and altered sensorium were first stabilized in the intensive care unit (ICU).

Patients with any contraindication to surgery, such as a recent cardiovascular event (e.g., acute coronary event, recent stroke), and/or poorly controlled comorbidities (e.g., acute kidney injury), were offered first, as be it drainage by percutaneous cholecystostomy (PCD), or medical management.

The criteria for PCD were a tense, overdistended BV and/or sealed local perforation, with clinical signs such as persistent fever, inability to tolerate fluids, elevated counts and C-reactive protein (predicting a poor response to medical management). That was followed by a CL after a period of 4-6 weeks. The PCD was removed at the time of LC. The time of the intervention was calculated from the beginning of symptoms and not from the moment the patients presented at the healthcare center.

LCs were, therefore, classified as early (performed immediately or within 1 week of symptom onset), intermediate (within 4-5 weeks of symptom onset), and late (≥6 weeks of symptom onset). of symptoms). Informed consents were obtained from all patients or their legal representatives, and possible complications and conversion to open cholecystectomy were explained to them. All surgeries were performed by the same surgeon, with two fellow assistants and operating room nurses.

A high-definition camera with 3 integrated circuits and xenon light source, a 10 mm 30º laparoscope, and a 23/26 inch medical grade monitor were used to obtain good visibility to ensure safe dissection in the cases. difficult

The following 7 safety steps were adopted to perform LC, based on the guidelines of the Society of American Gastrointestinal and Endoscopic Surgeons [9] and those of Tokyo [3,10,11] for the management of acute cholecystitis, and on the experience of the operating surgeon to overcome the difficulties encountered in achieving SVC in complex CALs. Those steps were not used in any particular order. Additionally, not all steps were required in all surgeries.

1.  Panoramic vision alternating with close vision of the laparoscope: intermittent withdrawal of the laparoscope was performed to evaluate the distance vision and precisely determine the anatomical relationships. The upper border of the duodenum was kept under vision to prevent inadvertent injury to the common bile duct, duodenum, and transverse colon.

2.  Clockwise and counterclockwise dissection: Starting from the inferior edge of the firmly grasped VB, the “flag technique” was used in a clockwise (posterior) and counterclockwise (anterior) direction to open Calot’s triangle. The goal was to stay above the Rouviere sulcus with the dissection and achieve SVC.

The impacted stone in the neck, if any, was milked upward and minimal lateral traction was used, to avoid misinterpretation of the common bile duct as a cystic duct. At least one-third of the gallbladder was dissected and lifted from the fossa before clipping or ligating the cystic duct. Retrograde dissection was adopted in selected cases with frozen Calot’s triangle.

3.  Ultrasonic dissection of the fibroadipose tissue: ultrasonic scissors were used for the dissection of the fibroadipose tissue to expose the cholecystohepatic fossa, thus minimizing the exudate of the inflamed and hypervascularized tissues, thus preventing – in this way – thermal injury of the intestine and the common bile duct.

4.  Use of a 5 mm suction cannula for controlled hydrodissection: Blunt hydrodissection, with minimal suction pressure, was performed with the tip of a 5 mm suction cannula, during anterior and posterior dissection. Intermittent irrigation not only opened the planes but also maintained clear vision during dissection.

5.  Early use of the fifth port: An additional fifth port was placed in the epigastrium, to the left of the midline, to retract the colon/duodenum in cases of BV bulge (pie formation). That port was also useful for using intermittent suction to keep the field clean for safe dissection.

6.  Needle decompression of a tense VB: the overdistended VB, with thickened walls, was aspirated, and the material sent for culture. Controlled decompression of the BV facilitates the traction and retraction movements of the BV, thereby aiding in the dissection of Calot’s triangle.

7.  Identification and control of the dominant posterior cystic artery: The dominant posterior cystic artery, if possible, was identified preventively and controlled during the posterior window dissection, thus minimizing bleeding and maintaining vision.

No intraoperative cholangiography was performed in any patient. A simple additional measure used in case of bleeding during dissection was firm compression with radiopaque gauze. This is simple and helps save time to switch to better energy devices.

In patients with gangrenous or perforated cholecystitis with generalized peritonitis, extensive lavage with saline solution was performed followed by placement of drains. The BV specimen and spilled stones, if any, were placed in a retrieval bag and removed through the umbilical port. The umbilical port was closed with a polypropylene/polydioxanone 1 suture, and the accuracy of closure was evaluated by introducing the laparoscope through the epigastric port.

Postoperatively, depending on the clinical status, patients were transferred to the ICU or the general surgery room. Patients were discharged once they were pain-free, ambulatory, and able to tolerate liquid diet. The abdominal drains were removed once their output was insignificant. All patients were advised to come for follow-up in case of fever, jaundice, and abdominal pain, or routinely on the 10th day and at 6 weeks, 3 months, and 1 year after surgery.

>  Data collection and analysis

The number of patients categorized as moderate and severe CAL (Tokyo Guidelines), their demographic data, diagnosis, timing of CL (early, intermediate or late), incidence of PCD, frequency of use of individual safety steps ( e.g., use of the 5th port, BV decompression, ultrasonic scissors, retrograde dissection), incidence of subtotal cholecystectomy, conversion to open surgery, duration of surgery, length of hospital stay, and postoperative complications, including those that required readmission for management.

The number and percentage of patients with moderate and severe CAL, and those who underwent early, intermediate, and late CL, were summarized. Patient age was summarized using mean and standard deviation, and compared using an unpaired t test between moderate and severe CAL.

Categorical data (gender, frequency of symptoms, abnormal laboratory results, comorbidities, diagnoses, use of safety steps, conversion to open surgery) were summarized using frequency (n) and percentage (%). Intraoperative diagnoses and use of safety steps were compared between moderate and severe CAL, using the Chi-square or Fisher’s exact test and, if necessary, between early, intermediate, and late CL. Duration of surgery and hospital stay were summarized using median, minimum, and maximum values, and compared using the Mann-Whitney U test . Postoperative complications were classified using the Clavien-Dindo classification [12].

All tests were 2-sided and a p value < 0.05 was considered significant. All statistical analyzes were carried out using the GraphInStat program (v3.1).

A total of 487 patients with CAL underwent LC between January 2008 and January 2018. Of them, 145 were categorized as CALC; 108 patients as moderate CAL (Grade II), and 37 as severe (Grade III).

The mean age of patients with CALC was 60 years. The mean age was significantly higher ( p = 0.0006) in patients with severe CAL. Fifty-seven patients (39.3%) were > 65 years old, of which 14 (9.7%) were ≥ 80 years old.

An overall preponderance of men was observed in the study (male:female ratio 2.53), with significantly more men than women in the severe CAL group. An independent observation was that 102 patients (70.3%) presented CAL as the first episode of symptomatic BV disease.

One hundred and eighteen patients (81.4%) were considered suitable for LC. It was carried out during the same hospital stay as the first time they attended the healthcare center, regardless of the time of presentation. Seventeen patients (11.7%) were considered unfit and received medical management, followed by CL ≥ 6 weeks after symptom onset (late CL). Ten (6.9%) (1 patient with moderate CAL and 9 with severe CAL) underwent PCD followed by delayed LC.

In general, empyema and acute inflammation were predominant in patients with moderate CAL, and gangrene and perforation of the BV were more commonly found in patients with severe CAL ( p = 0.0355).

Regarding the use of the 7 safety steps, panoramic vision, hydrodissection, and attempt to identify the posterior cystic artery were performed in all patients. The 5th additional port was required in 31.5% of patients (34/108) with moderate CAL, and in 51.3% (19/37) of patients with severe CAL.

Needle decompression and aspiration of the BV was performed in 34% of patients (37/108) with moderate CAL, and in 13% (5/37) with severe CAL. Using the standard 7 steps, VCS was achieved in all but 4 patients: 3 (2.8%) with moderate CAL and 1 (2.7%) with severe CAL.

All 4 patients underwent a restorative type of subtotal cholecystectomy, with equal distribution in early and late LC. Preventive conversion to open surgery was necessary in 2 elderly patients (1 [0.9%] with moderate CAL, and 1 [2.7%] with severe CAL), due to failure to progress the dissection.

The patient with moderate CAL had severe dense adhesions between the BV and the colon, limiting the safe plane of dissection; However, she had an uneventful postoperative recovery.

The other patient, with severe CAL, had multiple comorbidities in addition to BV empyema. Persistent oozing and a left subhepatic hemorrhage due to thrombocytopenia led to early conversion. On the 5th postoperative day, the patient died from cardiopulmonary arrest. The histopathological report revealed the presence of xanthogranulomatous cholecystitis.

Intraoperative visceral injury (transverse colon), during primary umbilical port insertion, occurred in 1 patient (0.9%) with moderate CAL and gangrenous BV. However, LC could be performed safely, and the perforation was sutured primarily by bringing the colon out through an enlarged umbilical port. The patient had an uneventful postoperative recovery.

Overall, the duration of surgery was 92 minutes, ranging from a minimum of 50 min to a maximum of 180 min, and was significantly longer in patients with severe CAL ( p = 0.0200) (median 90 min in CAL moderate and 100 min in severe CAL).

However, the duration of surgery did not differ significantly ( p = 0.1898) with the time of intervention (median 90 min in early LC, 93 min in intermediate, and 90 min in late).

Blood loss was minimal in most patients, except in 2 (1.4%) (1 patient with moderate CAL and another with severe CAL), who required transfusion of 1 unit of packed red blood cells each.

The histopathological findings were: suppurative BV in 54 patients (37.2%), gangrenous BV in 53 (36.6%), exacerbation of chronic cholecystitis in 24 (16.6%), chronic cholecystitis in 11 (7.6%). %), and xanthogranulomatous cholecystitis in 3 patients (2.1%). No malignancy was reported in any of the patients.

The mean length of hospital stay was 7 days, ranging from a minimum of 3 days to a maximum of 42 days, and was significantly longer in patients with severe CAL ( p < 0.0001) (median 5 days [ range: 3 to 42 days] in moderate CAL, and median of 8 days [range: 4 to 29 days] in severe CAL).

Overall, the incidence of surgical complications was low. There were 11 postoperative complications: surgical site infection (4); bile leak due to opening of the cystic duct stump (2); subcapsular abscess (2); port site hernia (1); subhepatic hematoma (1); and death due to acute myocardial infarction and cardiorespiratory arrest. Major postoperative complications requiring intervention were observed in 6 patients (4.1%). There was no bile duct injury.

The CAL has diverse presentations and results in the different healthcare centers. The classification of complex CAL based on the Tokyo Guidelines helps to prepare and follow an algorithmic treatment plan.

Adopting safety steps presented by experts in the field, and the surgical team, helped intervene regardless of the time of presentation. Although early cholecystectomy has been the preferred treatment in moderate CAL, for severe CAL, early drainage of BV and medical management, followed by cholecystectomy after an interval, has been the preferred approach [3,10].

In the series by the authors of this work, 62.2% of patients with severe CAL underwent initial LC. The decision to intervene early was based on the clinical and metabolic status of the patient. The Tokyo Guidelines recently published in 2018 support early LC, even in severe CAL, in the hands of experienced surgeons, in centers that have an ICU [11].

Forty-one of the patients [28.3%) presented in the intervening period of 2-5 weeks after the primary onset of symptoms. These patients had been treated elsewhere and presented with incomplete resolution of symptoms.

Labeling them as CALC helped to offer them an initial CL instead of the conservative approach. According to the literature, 30% to 40% of patients experience recurrent attacks in the intervening period [13,14]. Being in a tertiary referral healthcare center, the authors experience a similar scenario. In that group there was no significant difference in morbidity and mortality compared with patients who underwent early or late LC.

Retrograde dissection was used in 11.4%, and the 5th port in 43.2% of these patients. However, since the number is small, larger series are required to confirm the morbidity and outcomes of surgery in that group.

The proportion of patients (18.6%) who underwent late CL was greater in severe CAL, compared to moderate CAL. This was due to the time required for preoperative optimization of comorbid conditions, or the insertion of a PCD to ward off the crisis, and is consistent with literature findings, where severe acute cholecystitis has frequently resulted in greater delays to surgery. [15,16].

The 7 safety steps allowed successful manipulation of the surgical field, both in moderate and severe CAL. The incidence of LC-related complications in CALs is reported to be between 8.0% and 22.0% [15-17]. Bile duct injury is the most feared complication of LC in CAL (incidence between 0.2% and 7%) [16,18-20].

Although the present series had 2 cases (1.4%) of postoperative bile leak after partial cholecystectomy, there were no bile duct injuries. The incidence of bile leakage is comparable to that reported in the literature (0.6% to 2.0%) [15,17,21].

The rate of major postoperative complications requiring intervention was 4.1%, and comparable in moderate and severe CAL, as well as in early, intermediate and late LC. A mortality rate as high as 4% has been reported in acute cholecystitis, and is associated with advanced age, presence of comorbidities, and preoperative organ dysfunction [15,21].

In the present series, a single death (0.7%) occurred on the 5th postoperative day in a similar scenario. The 5th (additional) port, ultrasonic scissors, and retrograde dissection were used more frequently in patients with severe CAL, while needle decompression and aspiration of the BV were performed more frequently in moderate CAL. The 7 intraoperative safety steps helped minimize complications.

Several studies have identified advanced age (≥ 60 years), male sex, and presence of diabetes mellitus or cardiovascular disease as independent risk factors for severe and complicated cholecystitis [15,22,23].

In the present prospective study, of the 145 patients, 39.3% were > 65 years of age. A general preponderance (71.7%) of the male sex was observed. The number of male patients and the mean age were significantly higher in severe CAL. More than 80% of patients had one or more comorbidities. The possibility of offering initial surgery to this population, saving recurrent rehospitalizations, may be prudent.

An additional observation noted during the study period was that 70.3% of patients with moderate or severe CAL reported that it was their first episode of symptomatic BV disease, which is a higher percentage than that reported in the study. literature (47.0% to 67.0% of patients with acute cholecystitis or lithiasis in the common bile duct have warning episodes of biliary colic) [15]. That may be representative of a tendency to underreport symptoms, which frequently occurs in India.

Subtotal cholecystectomy is recommended in the acute setting with frozen Calot’s triangle, as a rescue method to prevent bile duct injury [11]. Recent CAL literature reports increased use of laparoscopic subtotal cholecystectomy, as well as residual stones in the remaining BV, leading to recurrent cholecystitis (up to 13.3%) [24].

In the present CALC series, the incidence of subtotal cholecystectomy was low compared to that reported in the literature (up to 6.7% [17]). Due to the systematic 7-step approach and unhurried dissection, partial/subtotal cholecystectomy was required in only 4 patients, in whom SVC was not achieved, out of 141 patients.

The incidence of subtotal cholecystectomy was comparable between moderate and severe CAL. Therefore, the authors recommend partial or subtotal cholecystectomy only in selected cases, when persistent and judicious dissection fails to demonstrate the SVC and Calot’s triangle.

Duration of surgery and conversion to open cholecystectomy are used as indicators of surgical difficulty [11,25]. Advanced age, male gender, acute cholecystitis, high body mass index, common bile duct dilation, and thickened BV wall are the few factors that are associated with prolonged surgical time, as well as conversion to open surgery. [11,26].

Most patients in this series had >1 of the aforementioned criteria, and operative time was significantly longer in patients with severe CAL. However, the duration of surgery decreased over time due to the experience of the surgical team in handling complex cases.

Conversion rates are known to range from 3.0% to 30.0% in moderate and severe CAL [27-29]. In fact, open cholecystectomy has been recommended to ensure patient safety. Failure to achieve SVC, even after 1 hour, led to conversion to open cholecystectomy in 2 patients. The low conversion rate (1.4%) in the present series highlights the importance of strict adherence to the operative protocol to achieve SVC.

Overall, the results document that initial LC is feasible and safe in CALC regardless of the time of presentation. Surgery may be deferred in the case of patients who have medical contraindications to surgery.

Confirmation of the clinical diagnosis by radiological and laboratory findings, recognition of the complexity of the disease by the preoperative classification of CAL, anticipation of difficulties, the decision to intervene early (either with initial surgery or by DCP), The use of standardized surgical techniques, and perseverance by the entire surgical team to achieve VCS, help reduce the incidence of subtotal cholecystectomy, conversion to open surgery, and complications of LC in CALC. The 7 safety steps are reproducible and can be adopted by surgeons performing LC in CAL.