Introduction

The introduction of the laparoscopic cholecystectomies has revolutionized general surgery. Faster recovery, shorter length of hospital stay and improved cosmetic results associated with the approach have made laparoscopic cholecystectomy the standard of care for the management of benign gallbladder diseases^1,2,3. But this has led to a rise in bile duct injuries (BDIs)⁴, resulting in an increase in the number of tests required to determine the best treatment, technique, and timing to address this issue. This has significant economic implications for the healthcare system, often leading to high rates of litigation and civil lawsuits ranging from USD250,000 to USD500,000⁵.

However, few studies have investigated the effects of BDIs and their subsequent repair on psychosocial and health-related quality of life (HRQL). Are the laboratory tests results and the assessment of symptoms by a physician more important than the assessment of HRQL? We present the first study evaluating HRQL in patients with BDIs managed by specialists in a referral center in Argentina.

The aim of the present study was to compare HRQL in a consecutive series of patients with BDIs before and after definitive treatment performed by specialists at a high-volume center.

Material and methods

We conducted a combined retrospective and prospective cohort study including patients referred to our center with a diagnosis of BDI between December 2015 and June 2019. The following variables were analyzed: sex, age, initial diagnosis, surgical procedure performed, attempts to repair the BDI before referral, number of procedures performed and time to definitive resolution. Bile duct injuries were categorized according to the Strasberg classification⁶. Complex injuries included those involving the hepatic duct confluence, injuries in which repair attempts have failed, any bile duct injury associated with a vascular injury, or any biliary injury in association with portal hypertension or secondary biliary cirrhosis⁷.

The 36-item Short Form Health Survey (SF36)⁸ was the instrument used to evaluate HRQL. The instrument measures 9 dimensions, with scores ranging from 0 to 100 (Appendix 1). The survey was answered either face-to-face or by telephone. An initial survey was conducted retrospectively, taking into account the patient’s condition 2 weeks before the BDI was solved; since 2018, it was conducted prospectively. The survey was repeated after the injury was definitively resolved in our center within a minimum waiting period of 2 months.

All the statistical calculations were performed using IBM SPSS Statistic 25 software package. The results were expressed as mean, median, range and 95% confidence interval. Categorical variables were analyzed with the chi square test. The SF-36 form was evaluated using the Student’s t test. The MannWhitney U test and the Kruskal-Wallis test were used to analyze the association between variables. A p value < 0.001 was considered statistically significant.

Results

A total of 48 patients with BDIs were referred to our center during the study period. Mean age was 40.5 years (range: 4-68) and 35 (72.9%) were women.

The diagnoses leading to the intervention in which the BDI occurred can be seen in Table 1. A total of 81.3% of the surgical interventions were scheduled procedures. In most of them, it is unknown if intraoperative cholangiography was performed, while it was performed in 27.1%. In 35% of cases, attempts were made to repair BDIs prior to referral to our center. The mean number of procedures performed before referral was 2.29 (range 0-26). Based on the Strasberg classification, more than 50% of BDIs were classified as type E1 or E2 (Table 2). Complex injuries occurred in 32 patients (66.7%); of these, 9 had associated vascular injury: 4 were only arterial injuries, 2 involved the hepatic artery and portal vein, and 3 involved only the portal vein. Forty-two patients (87.5%) received treatment at our hospital. Two patients are currently awaiting treatment: one will undergo endoscopic treatment and the other is on the liver transplant waiting list. One patient was lost to follow-up and 3 died while awaiting definitive treatment (2 on the transplant waiting list and one due to a complication of percutaneous treatment).

In 33 cases (78.5%), the definitive treatment was bilio-digestive bypass, which included hepaticojejunostomy, double hepaticojejunostomy, triple hepaticojejunostomy, or cholangiojejunostomy. In the remaining cases, definitive treatment was liver transplantation in 3 cases (7.1%), 3 (7.1%) were treated endoscopically, 1 (2.4%) underwent percutaneous treatment, 1 (2.4%) received combined percutaneousendoscopic management, and 1 (2.4%) only required laparoscopy and drainage.

The median time for BDI to definitively resolve was 264 days, with a range of 0 (intraoperative resolution) to 8055 days (secondary biliary cirrhosis). The overall mortality rate was 14.6% (7 patients). There was no correlation between mortality rate and complex injuries (p = 0.5). However, there was a correlation with vascular injury (p = 0.02) and with the type of treatment (p = 0.017).

Twenty-two patients (46%) completed the quality-of-life surveys (Table 3). Among the 26 patients who did not complete the survey, 15 patients were lost to follow-up, 7 had passed away, 2 were waiting for treatment, and 2 had resolved their BDI but did not comply with the minimum waiting period for the second survey. The statistical analysis demonstrated significant improvements (p < 0.001) in quality of life across all the domains: physical functioning (selfcare, walking, climbing stairs, bending, lifting weight, and moderate and vigorous activities), physical role functioning (interference with work or daily activities because of physical health), bodily pain, general health (present and future expectations), vitality (energy vs. fatigue), social functioning (how much health interferes with social interactions), emotional role functioning (limitations to work or daily activities because of emotional health), mental health (depression, anxiety, behavioral control, and emotional control), and health transition item (rating of current health compared to one year earlier) (Fig. 1). On univariate analysis, mental health was affected by the presence of a complex injury (p = 0.019). Physical and emotional role functioning before BDI repair were associated with the type of injury of the Strasberg classification (p = 0.001 and p = 0.032, respectively). An associated vascular injury had a negative correlation with physical functioning (p = 0.019), vitality (p = 0.033), mental health (p = 0.005), and pain (p = 0.026) prior to repair.

FIGURE 1 SF-36 assessment. Changes in quality of life before and after BDI repair in all domains of the SF-36 form 

Discussion

The SF-36 questionnaire is a validated tool widely used to assess quality of life following BDI^9,10,11,12. At present, the questionnaire is the most widely used worldwide; it has been translated into more than 20 languages and is considered the gold standard generic measure of health status¹³. Augustovski et al.¹⁴ demonstrated that the Argentine-Spanish version of the SF-36 (see Appendix 1) is a valid and reliable tool for outcome research in Argentina.

There is a limited amount of research on the quality of life of patients with BDI in the current literature, and even fewer studies have been conducted comparing quality of life before and after BDI repair.

In a meta-analysis by Landman et al.¹⁵, the authors concluded that BDI patients were more likely to have reduced mental but not physical HRQL compared with the general population. These findings illustrate the importance of addressing both technical and patient-reported outcomes such as HRQL in the immediate post-operative period and beyond.

Ejaz A. et al.¹⁶ reported their experience with 259 patients with BDI, with a rate response of 24%. Health-related quality of life was assessed before and after BDI repair. At the time of BDI, mental health appeared to be most affected, with nearly half of all patients reporting a depressed mood (49.2%) or low energy level (40.0%) “most” or “all the time” before BDI repair. These symptoms improved significantly after repair, as only 18.3% reported having a depressed mood and 18.0% having low energy “most” or “all the time”. Interestingly, limitations in physical activity and general health remained unchanged before and after surgical repair.

In our experience, after careful evaluation of both surveys, it is evident that the domains of emotional and physical role functioning experienced the most significant changes, with marked improvement in limitations to work or daily activities due to emotional and physical health. This difference was also evident when comparing the present health condition to that of the previous year.

The domain with the smallest difference, although also significant, was social functioning. Before treatment, 81.8% of patients reported feeling sad and discouraged ‘most’ or ‘all the time’, and 86.4% responded having low energy levels. These parameters varied dramatically after the definitive treatment: only 4.5% of patients reported feeling depressed while all patients answered their energy had improved and none reported low energy levels.

In a survey conducted on 168 patients with iatrogenic bile duct injury and a response rate of 64%, Rystedt et al.¹⁷ concluded that quality of life after BDI is comparable to uneventful cholecystectomy, if the injury is diagnosed intraoperatively. It is worth noting that their study had an exceptionally high proportion of BDIs detected intraoperatively (92%). Ninety percent of the patients with an intraoperative diagnosis of BDI were subject to an attempt to intraoperative repair of the injury. In 69% the repair was performed by the treating surgeon without assistance by a second senior surgeon. Patients with a postoperative/late diagnosis reported a reduced physical HRQL.

In our study of 48 patients with a response rate of 46%, equivalent to or greater than in other published studies, we observed that prior to definitive repair, patients’ health was dramatically affected in all domains included in the SF 36 survey (refer to Table 3). This may well be because a higher percentage of patients underwent late repair. Our center operates as a referral center, which can result in delays in the referral process. However, we have extensive experience in performing late repair procedures that are necessary for adequate control of sepsis, optimization of the clinical condition, and achieving optimal local conditions for performing the definitive repair.

Martinez-Lopez et al.¹⁸ evaluated a cohort of 63 patients with BDI and showed that a delayed referral was associated with a higher incidence of postoperative complications, requiring more invasive procedures and a longer recovery.

We have also observed that many patients referred to our center have undergone unsuccessful repair attempts by the treating surgeon despite several attempts to resolve the condition using different techniques, such as percutaneous drainage and endoscopic retrograde cholangiopancreatography (ERCP) in low-volume centers.

Stewart and Way¹⁹ reported that only 13% of all repair procedures performed by the initial surgeon with no experience in hepatobiliary and pancreatic (HPB) surgery were successful. Other studies have shown similar results, recommending that definitive treatment should be performed by a surgeon specializing in HBP surgery^20,21,22. According to Dageforde et al.²³, repairs performed by nonspecialist surgeons were associated with significantly higher costs due to low success rates and high complication rates. Modern studies report complication rates close to 80%.

In conclusion, based on the experience presented here, we can affirm that the definitive resolution of patients with BDI at a center specialized in HBP surgery resulted in a significant improvement of patients’ quality of life. Although our initial experience has been carried out on a small population, this is the first publication that includes a study on HRQL in patients with BDI in Argentina.