Real Benefits of the Laparoscopic Approach


N. 1

Evidence-based guidelines
 
N. 1

Meta-analysis of retrospective case-control or case-series study

LoE 4

N. 7

Randomized controlled trial

N.2: LoE 3a N.5: LoE 2

N. 10

Nonrandomized prospective cohort/observational study

LoE 3

N. 8

Case-control study

LoE 4

N. 2

Case series

LE 4


aEvidence Level was downgraded from 2 to 3 because the study population is small



Level of evidence of these selected papers was graded according to Oxford Centre for Evidence-Based Medicine 2011.



9.3 Considerations


An effective way to investigate the factors that may influence QoL outcomes after LC would be to measure the pre- and postsurgery satisfaction rate (QoL assessment is generally suggested at the 1st and 6th months after surgery) administrating SF-36 as generic instrument in conjunction with GIQLI as disease-specific instrument. If time and resources are limited, the GIQLI may be used alone because it incorporates all domains of a QoL assessment.

We pointed our attention to the QoL considering the following main topics:

(a)

Effectiveness of LC

 

(b)

Comparison to OC

 

(c)

Comparison to small-incision laparotomic cholecystectomy (SC)

 

(d)

Impact of iatrogenic bile duct injury (BDI)

 


9.3.1 QoL After LC: Is the Operation Effective?


From our systematic review of the literature, after exclusion of duplicates, we found only three prospective cohort studies concerning QoL after LC [13] [LE 3] (Table 9.2).


Table 9.2
QoL after LC in 3 prospective nonrandomized study (410 patients)



































Author

Test

Questionnaire delivered

Response rate (%)

Finan KR [LoE 3] [1]

SF-36

Median follow-up 17.1 months (range 2–32)

64

GISS (gastrointestinal symptom survey)

Lien HH [LoE 3] [2]

SF-36

12 months

100

GIQLI (Taiwan version)

Hon-Yi [LoE 3] [3]

SF-36

3, 6, 12, and 24 months

72.5

GIQLI (Chinese version)

Finan et al. designed a study to determine gastrointestinal symptoms and QoL after cholecystectomy for better measurement of the change in QoL after surgery [1] [LoE 3]. This is a prospective cohort of consecutive patients with a small population (55 subjects) at a mean time to follow-up of 17.1 months; indeed only 64 % of patients involved in the study returned the filled questionnaire. In this study, SF-36 was employed along with a symptom survey that was designed to include both classic symptoms of biliary disease and other benign gastrointestinal (GI) diseases. Their results showed that LC significantly improved GI symptoms as well as QoL in subjects with symptomatic gallstone disease; nevertheless symptoms associated with reflux (food or stomach contents in the throat, belching, feeling full after small meals, and pressure in the chest), irritable bowel syndrome (flatulence, constipation, and diarrhea), and chronic pain (pain all the time) did not show significant improvement. These results support the effectiveness of LC for elective biliary disease, with particular attention in regard to appropriate selection of patients, especially in terms of discrimination between biliary disease-related symptoms and other GI disorders.

Lien et al. reported the results of a prospective nonrandomized follow-up study on a cohort of 99 consecutive patients evaluated preoperatively and 12 months after surgery with SF-36 and GIQLI [2] [LoE 3]. The preoperative SF-36 scores from gallstone patients were significantly inferior to an age- and sex-matched control population; LC effectively reduced gastrointestinal symptoms, confirmed by the improvement in GIQLI total, physical well-being, mental well-being, gastrointestinal digestion, and defecation subscale scores; particularly patients with worse preoperative health condition are shown to benefit from greater QoL improvements following LC surgery. Yet some patients did not regain full GIQLI scores after surgery, deducing that some residual gastrointestinal discomfort remained 12 months after surgery.

Shy et al. reported the scores of SF-36 and GIQLI before surgery and then at 3, 6, 12, and 24 months after surgery in a prospective cohort study that includes 353 consecutive patients [3] [LoE 4]. Only 72.5 % of them returned the questionnaire after 24 months of follow-up, so the study consisted of 256 patients. All the LC patients had significantly improved GIQLI and SF-36 subscale scores at the 6-month follow-up survey. Interestingly most dimensions of the GIQLI and the SF-36 improved remarkably not only until the first year after surgery but also thereafter. In each GIQLI dimension, the fastest improvement occurred immediately after surgery and then reached a plateau after approximately 2 years. In particular, among eight SF-36 subscales, physical functioning, role physical, and role emotional showed the best improvement by the second year after surgery. HRQoL improvement after LC was inversely related to age, and according to Lien HH, the best predictors of postoperative HRQoL were preoperative functional status scores. The authors suggested that direct interventions to reduce role limitations due to physical and emotional problems may enhance physical functioning of patients after LC, increasing HRQoL in all dimensions.

We found only one paper in which the impact on QoL of a perioperative intervention after LC was investigated [4] [LoE 3]. The study was a randomized single-blinded trial, in which a population of 60 patients was followed up and analyzed. Those in the intervention group attended a standardized 45 min relaxation session with a health psychologist and were given relaxation exercise compact disk to take home; the control group did not have the intervention. Both groups had similar fatigue at baseline measured using the identity-consequence fatigue scale. The results of the trial demonstrated a reduction of fatigue on postoperative day 30 in the intervention group, allowing faster return to normal functions and activities.

From the above it could be deduced that:



  • LC significantly improved either GI symptoms or QoL in subjects with symptomatic gallstone disease.


  • Best results may be achieved by an appropriate selection of patients, in terms of discrimination between biliary disease-related symptoms and other GI disorders.


  • Patients with worse preoperative health condition are shown to benefit from greater QoL improvements following LC surgery.


  • Preoperative functional status scores are the best predictors of postoperative HRQoL.


9.3.2 QoL After LC Versus OC


EAES evidence-based guidelines on the evaluation of QoL after laparoscopic surgery published in 2004 focused on comparison of QoL after LC and OC [5]. Two randomized and eight nonrandomized trials were analyzed [615] [LoE 2]. The authors reported that LC improves QoL faster than OC and that long-term results after LC are slightly better or not different compared to OC. However, the authors included in the study publications that compare LC with classical OC together with publications that compare LC with SC. In particular there were no randomized controlled trials (RCT) in which QoL after LC was compared with QoL after classical OC: four prospective nonrandomized longitudinal studies and four retrospective case–control or population studies were cited in EAES guidelines about this topic [815] [LoE 3].

Sanabria et al., using an ad hoc questionnaire over an 8-week period after laparoscopic or open cholecystectomy, studied all patients who underwent elective cholecystectomy during three consecutive periods; there were 121 patients in each period [8] [LoE 4]. In the first period all patients underwent OC, in the second period 58 % underwent LC, and in the last period almost all patients underwent LC. A significantly shorter hospital stay and shorter recovery period in favor of LC was found, but at the final evaluation, the patients’ answer did not differ between groups regarding their postoperative QoL.

Eypash et al. evaluated a cohort of 179 patients (21 OC versus 158 LC) with GIQLI and VAS score 2 and 6 weeks after surgery; QoL score was then compared with 70 healthy persons [9] [LoE 4]. LC resulted in immediate postoperative improvement of QoL; at both time points, there was a trend toward better QoL in the laparoscopic group.

Ludwig et al. used GIQLI in a prospective nonrandomized comparative study including 103 patients (29 OC and 74 LC) with 35 days of follow-up. The authors reported a quicker convalescence after LC with an earlier return to work [10] [LoE 3].

Plaisier et al. prospectively studied the course of QoL and gastrointestinal symptoms after laparoscopic and open cholecystectomy, demonstrating that LC improved QoL and symptomatology at an earlier stage than OC, yet the population of the study was very small including 31 patients only (14 LC and 17 OC) [11] [LoE 3].

Similarly Chen et al. confirmed in their prospective nonrandomized trial, in which GIQLI was used preoperatively and then 2, 5,10, and 16 weeks after surgery, that LC can improve the QoL better and more rapidly than OC [12] [LoE 3]. Even for this paper the population of the study was small (51 patients).

Kane et al. retrospectively evaluated consecutive cases of elective cholecystectomy from 35 hospitals sending an ad hoc questionnaire about symptoms and functional status 6 months postoperatively [13] [LoE 4]. The questionnaire was returned in 76 % of cases; the population studied consisted of 2.481 patients: no difference in pain, symptoms, or general health was noted after LC or OC, but the mean time to return to work and to perform usual activities was significantly shorter for LC.

Topcu et al. performed a retrospective comparative study on 200 patients (100 LC and 100 OC) using the SF-36 questionnaire with a mean administration time of more than 40 months [14] [LE 4]. Both groups were comparable prior to surgery for demographic data, but no data about preoperative QoL were reported. The gastrointestinal clinical symptoms were similar in the two groups during the long-term follow-up evaluation, but LC was found to be significantly superior to OC with respect to the QoL over the long term. Authors reported a statistically significant difference in the scores of all eight domains of SF-36 in favor of LC; it would be understandable if the social aspect of QoL were impacted due to worse cosmesis after OC, but it is surprising that other aspects of QoL still showed significant differences as long as more than 3 years after the operation. Because preoperative QoL is not reported, these differences could simply reflect preexisting pretreatment differences; moreover, QoL data were not periodically collected, and the protracted period of more than 3 years that elapsed between the operation and the data collection casts more doubt on the reliability of the findings.

Quintana et al. conducted a prospective observational study of consecutive patients using GIQLI and SF-36 questionnaires [15] [LE 3]. 77.6 % patients (688 subjects) completed the questionnaires both before and 3 months after the intervention. HRQoL improvement at 3 months was relevant and similar for both surgical techniques, although the health transition perception was worse for those who underwent open surgery. Yet it must be noted that these results may depend by significant differences of the groups for sociodemographic and preoperative clinical variables. Patients who underwent OC had indeed symptomatic lithiasis with complications more frequently than those who underwent LC, mean age was older, and there were more patients with comorbidities and high surgical risk, measured by the ASA (American Society of Anesthesiologists) score, in the group treated with OC.

From our systematic review of the literature, we identified three papers comparing QoL after LC or OC: there are no randomized controlled trials [1618] [LoE 3].

Velanovich et al. prospectively assessed the health status outcomes of 100 patients who underwent different types of laparoscopic and open procedures using SF-36 questionnaire before and 6 weeks after surgery [16] [LoE 3]. LC had better QoL outcomes than OC, but in the paper three other procedures are mixed with cholecystectomy, and the population who underwent cholecystectomy in the study is very small.

Hsueh et al. reported a large-scale prospective cohort study in which GQLI and SF-36 were used preoperatively and then 3 and 6 months after the procedure in 297 patients (38 OC and 259 LC) [17] [LoE 3]. They reported that HRQoL of patients who underwent cholecystectomy was significantly improved at 3rd and 6th months after surgery. At 3rd month postsurgery, HRQoL was significantly larger in LC than in OC patients. Additionally, after controlling for related variables, preoperative health status was significantly and positively associated with each subscale of the GQLI and SF-36 throughout the 6 months.

At last in the study of Matovic et al., 59 and 61 patients respectively treated with LC and OC were prospectively studied using GLQI before surgery and then at 2-, 5-, and 10-week intervals after surgery [18] [LE 3]. Patients’ QoL at 2 and 5 weeks was significantly better in laparoscopic method group versus open method group in all four domains of GLQI, but after 10 weeks there were no differences in QoL total and domain score between two groups.

In conclusion, as a general agreement, postoperative QoL depends on preoperative clinical status: patients with worse preoperative health condition may benefit from better QoL improvements following LC surgery. There are no RCT or high-evidence-level studies that compare QoL after LC or OC. Based on the studies available, even though LC improves QoL faster than open surgery, long-term results are only slightly better or show no difference compared to OC (Table 9.3); at the same time, these data should be considered as a mean and might be limited to study design (e.g., small sample size, biased and confounding variables, low response rate to questionnaires).


Table 9.3
QoL: LC versus OC data from E.A.E.S. Evidence-based guidelines 2004 (4,096 patients) and 3 prospective non-randomized studies (447 patients)












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Mar 29, 2017 | Posted by in GASTROENTEROLOGY | Comments Off on Real Benefits of the Laparoscopic Approach

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