Patient-reported Outcome Measure (PROM) Rand-36-item Health Survey for Gallstone Disease Patients Five Years Following Surgery: A Prospective Randomized Study.

BACKGROUND/AIM: There are no studies assessing the long-term quality of life (QoL) following three-dimensional laparoscopy cholecystectomy (3D-LC) in patients with cholelithiasis (Chole). PATIENTS AND METHODS: A cohort of 200 patients with Chole were randomized into 3D-LC or minilaparotomy cholecystectomy (MC) groups. RAND-36 survey was performed before randomization, four weeks and five years postoperatively. RESULTS: Similar postoperative five years RAND-36 scores were reported in the 3D-LC and MC groups. The MC and 3D-LC groups combined analysis, social functioning (SF, p=0.007), mental health (MH, p=0.001), role physical (RP, p<0.001) and bodily pain (BP, p<0.001) domains increased significantly. In comparison to the Finnish reference RAND-36 (FRR) scores, the scores at five years increased significantly in the MH domain, while four RAND-36 domains; Physical functioning (PF), general health (GH), RP, BP remained significantly lower in comparison to the FRR scores. CONCLUSION: A relatively similar long-term outcome in the 3D-LC and MC patients is shown. Interestingly, five RAND-36 domains increased during five years follow-up, while four RAND-36 domains remained lower than FRR scores, which may indicate onset of possible new symptoms following cholecystectomy in long-term follow-up.

A Possible Role of Interleukin-18 Binding Protein in Immune Regulation of Postoperative Pain: A Prospective Randomized Clinical Trial.

BACKGROUND/AIM: A possible role of interleukin-18 binding protein (IL-18BP) in immune regulation of pain and analgesics following surgery is rarely studied. The aim of this study was to investigate serum IL-18BP values in a cohort of laparoscopic cholecystectomy (LC) and minilaparotomy cholecystectomy (MC) patients and to establish their relationship with other cytokines and number of analgesic doses (NAD) of LC and MC patients postoperatively. PATIENTS AND METHODS: Blood levels of IL-18BP, six other interleukins (IL-18, IL-1ra, IL-6, IL-10, IL-1ß, and IL-8) and high-sensitivity C-reactive protein were measured before operation (PRE), immediately after operation (POP1), and six hours after operation (POP2) in 114 patients with cholelithiasis. RESULTS: Following surgery, the mean serum IL-18BP values correlated significantly to numeric rating scale (NRS) pain scores at 24 hours (r=0.194, p=0.009). In addition, the mean serum IL-18BP values correlated significantly to NAD (r=0.254, p<0.001). CONCLUSION: IL-18BP, a soluble antagonist of IL-18, correlates to NRS and NAD in LC and MC patients, which may support a possible role of IL-18BP in immune regulation of postoperative pain.

First RAND-36-Item Health Survey in Three-dimensional Laparoscopy Cholecystectomy: A Prospective Randomized Study.

BACKGROUND/AIM: National healthcare organizers require feedback from patients to improve medical treatment methods. Three-dimensional laparoscopy cholecystectomy (3D-LC) is a modern technique in surgery. However, there are no studies with patient feedback from validated questionnaires assessing the postoperative treatment results in 3D-LC. PATIENTS AND METHODS: Initially 200 patients with symptomatic cholelithiasis were randomized into 3D-LC or mini-laparotomy cholecystectomy (MC) groups. RAND-36-Item Health Survey was performed preoperatively and 4 weeks following surgery relating the survey scores between the 3D-LC and MC groups. RESULTS: Similar postoperative RAND-36 scores were reported for both groups preoperatively and at 4 weeks following surgery, and no significant differences in RAND-36 domains were shown. When the patients in both study groups were combined, Mental Health (p<0.001), Bodily Pain (p=0.01) and General Health (p=0.016) domain scores were significantly higher, indicating a significantly positive change in quality of life 4 weeks postoperatively, while those for the Role-Physical domain were significantly lower, indicating reduced physical activity during the 4 weeks following surgery. In comparison to the Finnish reference RAND-36 scores, scores at 4 weeks were significantly higher for the Mental Health domain (MC group, p<0.001 and 3D-LC group, p=0.001) whilst scores were significantly lower in four other domains: Physical Functioning, Social Functioning, Bodily Pain and Role-Physical. CONCLUSION: This study shows, for the first time using the RAND-36-Item Health Survey, relatively similar short-term outcomes in patients 4 weeks following cholecystectomy by 3D-LC and MC. Although scores for three RAND-36 domains were significantly higher postoperatively, indicating a significantly positive change in quality of life, a longer follow-up after cholecystectomy is needed for final conclusions to be drawn.

Three-dimensional Laparoscopy (3D-LC) Versus Minilaparotomy (MC) in Cholecystectomy: A Prospective Randomized Study.

BACKGROUND/AIM: Three-dimensional laparoscopy (3D-Lap) is a recent innovation in surgery. The 3D-Lap is rarely used in cholecystectomy (3D-LC) and there are no prospective studies assessing advantages and disadvantages of 3D-LC versus minilaparotomy (MC) in cholecystectomy. PATIENTS AND METHODS: This was a prospective clinical study conducted in the Kuopio University Hospital, including 200 patients with symptomatic cholelithiasis who were randomized into 3D-LC (n=112) or MC (n=88) groups. The numeric rating scale (NRS) pain score and number of analgesic doses (NAD) following surgery were documented. RESULTS: Similar low postoperative pain scores were reported in the 3D-LC and MC groups during the first hours following surgery, although the 3D-LC patients reported lower NRS pain score (p<0.05) one hour postoperatively. Interestingly, the 3D-LC patients showed significantly less pain 24 hours following surgery, the mean of NRS of 0-10 score at rest being 1.2 in the 3D-LC group versus 2.2 in the MC group (p<0.001), and the pain at the quick movement/coughing, the mean NRS being 2.9 in the 3D-LC group versus 3.6 in the MC group (p=0.05). CONCLUSION: The 3D-LC patients reported significantly lower pain scores 24 hours postoperatively than MC patients. However, the patient experience of pain depends on many factors and our results suggest that both 3D-LC and MC are safe and efficient techniques for cholecystectomy.

Interleukin-18 (IL-18) Cytokine Serum Concentrations Correlate With Pain Scores and the Number of Analgesic Doses Following Surgery.

BACKGROUND/AIM: Anti- and proinflammatory cytokines and plasma high-sensitivity C-reactive protein (hs-CRP) are used to assess inflammatory stress response (ISR) following surgery. However, the serum IL-18 (interleukin-18) cytokine values versus numeric rating scale (NRS) pain score and number of analgesic doses (NAD) postoperatively are unknown. PATIENTS AND METHODS: Blood levels of six interleukins (IL-18, IL-1ra, IL-6, IL-10, IL-1ß, and IL-8) and hs-CRP were measured at three time points; before operation (PRE), immediately after operation (POP1), and six hours after operation (POP2) in 114 patients with cholelithiasis. RESULTS: Following surgery, the blood levels of hs-CRP and IL-1ra, IL-6, IL-10, and IL-1ß cytokines had a trend for increase (p<0.001 and p=0.014, respectively). The serum IL-18 concentrations inversely correlated to NRS and NAD during the first 24 h postoperatively. CONCLUSION: The correlation of IL-18 levels to NRS and NAD values supports the hypothesis that ISR and pain are related.

Plasma Concentration of the Lipid Peroxidation (LP) Biomarker 4-Ηydroxynonenal (4-HNE) in Benign and Cancer Patients.

BACKGROUND/AIM: The present study investigated the plasma concentration of the lipid peroxidation (LP) biomarker 4-hydroxynonenal (4-HNE) in benign and cancer patients having the rectus sheath block (RSB) analgesia after midline laparotomy. Plasma concentrations of catalase (CAT) and malondialdehyde (MDA) were used as a reference. PATIENTS AND METHODS: This study assessed three LP biomarkers; CAT, MDA and 4-HNE and compared the plasma levels to the patient satisfaction 24 h postoperatively (SFS24; 0=fully unsatisfied; 10=fully satisfied); the overall pain at rest (NRSr) and when pressing the wound at 20 Newton force (NRSp) were surveyed and filed on a 11-point numeric rating scale at 24 h following surgery (NRS; 0=no pain; 10=worst pain). There were 56 patients in the study, of whom 12 were excluded due to missing plasma samples. The final study cohort consisted of 15 patients with benign disease and 29 patients with cancer. RESULTS: The RSB analgesia enhanced significantly the SFS24 scores in the study groups (p=0.001). The plasma 4-HNE decreased immediately after operation (POP1) and the postoperative decrease between the preoperative and the POP1 values in the 4-HNE marker were statistically significant (p<0.001). The individual plasma 4-HNE and MDA concentration correlated significantly in benign and cancer patients (r=0.413, p<0.001). CONCLUSION: The present study confirms the applicability of the plasma biomarker 4-HNE to cast further light on the postoperative pain in midline laparotomy patients.

A Finnish Version of RAND-36-Item Health Survey Versus Structured Interview 8 Years Postoperatively.

BACKGROUND/AIM: The aim was to assess the 8-year health status after minicholecystectomy (MC) versus laparoscopic cholecystectomy (LC) for gallstone disease (GS) by using the RAND-36 Health Survey. PATIENTS AND METHODS: Initially, 88 patients with symptomatic GS disease were randomized to undergo either MC (n=44) or LC (n=44). RAND-36 survey was performed 8 years postoperatively. RESULTS: In three RAND-36 domains (social functioning, role physical, role emotional) MC procedure was significantly better than LC. In MC patients, the 8-year postoperative scores of social functioning (p<0.001), role physical (p=0.002) and role emotional (p<0.001) were significantly higher than the age- and gender -adjusted Finnish reference scores. CONCLUSION: The Finnish version of the RAND-36 survey can be used as a valid and reliable method for measuring the quality of life and long-term outcome of cholecystectomy patients following surgery.

The Induction of Antioxidant Catalase Enzyme With Decrease of Plasma Malonidialdehyde: An Important Reactive Oxidative Species Inhibiting Mechanism.

BACKGROUND/AIM: The simultaneous increase of antioxidant CAT (catalase) enzyme and plasma MDA (malonidialdehyde) concentrations versus the numeric rating scale (NRS) pain score following surgery is unknown. Patients and Methods: The study included 114 patients with gallstone disease and 29 patients in the cancer group. RESULTS: Following surgery, the plasma CAT concentrations increased and plasma MDA concentrations decreased in all patients and especially in cancer patients. The linear mixed model time-effect was statistically significant in CAT and MDA (p<0.001 and p=0.02, respectively). In addition, a significant correlation between NRS pain score values and plasma MDA median concentrations in cancer patients was identified (r=0.430, p<0.001). CONCLUSION: The plasma MDA concentrations decreased and CAT concentrations increased significantly in all patients and especially in cancer patients following surgery. The simultaneous increase of antioxidant CAT enzyme with the decrease of plasma MDA may be an important ROS inhibiting mechanism to help patients return to normal antioxidant-oxidant status.

The Rectus Sheath Block (RSB) Analgesia Following Laparotomy Could Affect Malonidialdehyde (MDA) Concentrations in Benign Disease and Cancer.

BACKGROUND/AIM: The aim of the study was to compare the MDA (malonidialdehyde) plasma concentrations versus CAT (catalase)/NT (nitrotyrosine) plasma concentrations, patient satisfaction and pain score at rest/pressure to the wound area in laparotomy patients with rectus sheath block (RSB) analgesia. PATIENTS AND METHODS: Initially, 56 patients were randomized to four groups; control group (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) RSB analgesia groups. The plasma concentrations of CAT, NT and MDA markers were measured just before, immediately after and 24 h after operation. RESULTS: The RSB analgesia enhanced significantly patient satisfaction (p=0.001). The plasma MDA decreased immediately after operation (POP1) and the postoperative decrease between the preoperative and the POP1 values in the MDA marker were statistically significant (p<0.001). In linear mixed model, the time effect in both the single group and in the benign group in plasma NT biomarker was statistically significant (p=0.001, p=0.013, respectively). The median plasma MDA concentrations (ng/ml) following surgery were significantly lower in patients with cancer versus patients with benign disease (589 vs. 852, p=0.021). Jitterplots of the individual plasma NT versus plasma MDA showed that there was significant correlation in benign and cancer patients (r=0.347, p<0.001). CONCLUSION: Plasma MDA decreased significantly after operation in all patients and cancer patients had significantly lower MDA concentrations following surgery than patients with benign disease.

Brief Pain Inventory (BPI) Health Survey After Midline Laparotomy With the Rectus Sheath Block (RSB) Analgesia: A Randomised Trial of Patients With Cancer and Benign Disease.

BACKGROUND/AIM: Our original hypothesis was that the rectus sheath block (RSB) analgesia could enhance patient satisfaction and decrease pain following midline laparotomy. PATIENTS AND METHODS: Initially, 56 patients were randomized into four groups; control group (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) RSB analgesia groups. The BPI (Brief Pain Inventory) survey was conducted preoperatively and at one and four weeks and 12 months postoperatively. The patients pain 24 h postoperatively and satisfaction 48 h postoperatively was filled on an 11-point numeric rating scale (NRS). RESULTS: The repeated-dose group had lower BPI severity score (p=0.045) and BPI interference score (p=0.043) mean values postoperatively compared to the three other groups separately. Also, the time effect on the linear mixed model in BPI interference score mean values was statistically significant (p=0.008), which means that in the repeated dose group preoperative BPI severity score [2.7 (3.9)] and interference score [4.3 (4.2)] mean (SD) values were significantly higher than the BPI severity score [1.3 (0.8)] and interference score [1.5 (1.8)] mean (SD) values following surgery. CONCLUSION: The higher elevation in BPI severity score and decrease in interference score values in the repeated dose group and also the time effect in a linear mixed model in BPI interference score were statistically significant.

RAND-36-Item Health Survey: A Comprehensive Test for Long-term Outcome and Health Status Following Surgery.

BACKGROUND/AIM: The aim of this study was to assess the 3-year health status of cholecystectomy patients by the RAND-36 Survey. PATIENTS AND METHODS: Initially, 110 patients with symptomatic gallstone disease were randomized to undergo either minicholecystectomy (MC) (n=58) or laparoscopic cholecystectomy (LC) (n=52). RAND-36 survey was performed preoperatively, 4 weeks, 6 months and 3 years following surgery. RESULTS: RAND-36 scores improved in several RAND-36 domains in MC and LC groups with a similar postoperative course over the 3-year study period. In addition, at the 3-year follow-up telephone interview, no significant differences in patient-reported outcome measures between MC and LC patients were shown. The linear mixed effect model was used to test the overall significance of the RAND-36 survey during a 36-month follow-up period and the overall p-values were statistically significant in vitality, mental health (0.03), role physical and bodily pain domains. CONCLUSION: During the three years following cholecystectomy, four RAND-36 domains remained significantly higher, indicating a significant positive change in quality of life. RAND-36-Item Health Survey is a comprehensive test for analyzing long-term outcome and health status after cholecystectomy.

Rectus Sheath Block (RSB) Analgesia Could Enhance Significantly the Patient Satisfaction Following Midline Laparotomy in Benign Disease and in Cancer: A Prospective Study With Special Reference to Nitrosative Stress Marker Nitrotyrosine (NT) Plasma Concentrations.

BACKGROUND/AIM: Our hypothesis was that rectus sheath block (RSB) analgesia could enhance satisfaction following midline laparotomy in patients with benign disease and cancer patients. PATIENTS AND METHODS: Initially, 56 patients were randomized into four groups; control group (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) RSB analgesia groups. The plasma concentrations of the NT marker were measured just before, immediately after and 24 h after operation. Patient satisfaction at 24 h postoperatively was filed on a 11-point numeric rating scale (SFS24; 0=fully unsatisfied; 10=fully satisfied). RESULTS: The RSB analgesia significantly enhanced the SFS24 scores in the study groups (p=0.001). The median plasma NT concentrations (pg/ml) following surgery (POP1) were significantly lower in patients with cancer versus patients with benign disease (5.3 vs. 7.6, p=0.008). Jitter plots of the individual SFS24 values versus plasma NT concentrations were significantly correlated in benign and cancer patients (r=-0.284, p=0.028). CONCLUSION: The RSB analgesia could significantly enhance patient satisfaction following midline laparotomy. Plasma NT concentrations versus patient satisfaction following surgery are significantly correlated in benign disease and cancer.

Nitrotyrosine (NT), a Nitrosative Stress Biomarker, Plasma Concentrations in Gallstone Disease and Cancer Patients.

BACKGROUND/AIM: The aim of this study was to assess the plasma concentration of the nitrosative stress biomarker nitrotyrosine (NT) in gallstone disease and cancer patients. MATERIALS AND METHODS: Initially, 114 patients with symptomatic gallstone disease were randomized into the laparoscopic cholecystectomy (LC) (n=54) and the minicholecystectomy (MC) (n=60) groups. The plasma concentrations of NT were measured just before, immediately after (POP1) and 6 h after operation (POP2). The cancer patients of this study included ten patients with gastrointestinal cancer and 19 patients with gynecological cancer. RESULTS: There was a statistically significant correlation in the median plasma NT concentrations versus plasma catalase (CAT) concentrations in cholecystectomy patients (r=0.169, p=0.001). Interestingly, there was a statistically significant inverse correlation between the individual values of the pain assessed and filed using a 11-point numeric rating scale 8 h postoperatively (NAD8) and plasma NT median values in cholecystectomy patients (r=-0.337, p=0.004). CONCLUSION: Patients with high plasma concentrations of NT appeared to have significantly lower pain scores 8 h postoperatively.

Plasma Catalase in Relation to Pain Following Midline Laparotomy: A Prospective Study of Patients with Benign Diseases and Patients with Cancer.

BACKGROUND/AIM: The relationship of plasma concentrations of the oxidative stress biomarker catalase with pain on numeric rating scale at rest (NRSr) and under wound pressure 24 hours postoperatively (NRSp) in midline laparotomy patients with rectus sheath block (RSB) analgesia are unknown. Our original hypothesis was that RSB analgesia might reduce postoperative pain. PATIENTS AND METHODS: Initially, 56 patients were randomized to four groups: control group (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) RSB analgesia groups. The plasma concentrations of catalase were measured immediately before, immediately after and 24 hours after surgery. The pain at rest and under pressure were scored on an 11-point numeric rating scale 24 hours postoperatively (NRSr and NRSp; 0: no pain; 10: worst pain). RESULTS: The median plasma concentration of catalase increased immediately after surgery (p=0.007), but then decreased 24 hours postoperatively compared with immediately after surgery (p<0.001). The control group and the RSB groups did not differ in individual NRSr and NRSp values following surgery. Scatter plots of the plasma catalase versus superoxide dismutase concentrations were positively correlated in the patients (r=0.314, p<0.001). In addition, scatter plots of the individual NRSr and NRSp values versus plasma values of catalase were inversely correlated in patients (r=-0.221, p=0.03 and r=-0.238, p=0.02, respectively). CONCLUSION: The RSB analgesia does not reduce postoperative pain. Plasma catalase levels and pain following surgery are significantly correlated in patients regardless of disease type.

Cholecystectomy Patients with High Plasma Level of Catalase Have Significantly Lower Analgesia Requirement: A Prospective Study of Two Different Cholecystectomy Techniques with Special Reference to Patients with Cancer.

BACKGROUND/AIM: The plasma level of the oxidative stress biomarker catalase in patients with gallstone disease has not been previously compared with that of patients with cancer. Moreover, the number of analgesic doses required during the first 24 h postoperatively (NAD24) after laparoscopic cholecystectomy (LC) or mini-cholecystectomy (MC) in patients with gallstones is unreported. The aim of the present study was to determine the correlation between the plasma catalase level in patients with gallstones according to cholecystectomy technique versus patients with cancer. PATIENTS AND METHODS: Initially, 114 patients with symptomatic gallstone disease were randomized into LC (n=54) or MC (n=60) groups. The plasma level of catalase was measured immediately before, immediately after and 6 hours after operation. RESULTS: The median plasma catalase levels preoperatively and following surgery in the LC and MC patients versus those with cancer did not differ statistically significantly. The median plasma level of catalase increased immediately after operation, but the alteration was statistically insignificant (p=0.132). Interestingly, there was a statistically significant weak inverse correlation between the individual NAD24 and median plasma catalase values postoperatively in patients with gallstone disease (r=-0.283, p=0.042). CONCLUSION: The plasma catalase levels preoperatively and following surgery in the LC and MC patients versus those with cancer were quite similar. Cholecystectomy patients with high plasma levels of catalase appeared to require significantly fewer analgesic doses during the first 24 hours postoperatively (NAD24), suggesting that better oxidative balance following surgery could have a protective role against postoperative pain.

Gallstone Patients with Enhanced Oxidative Stress Biomarker Superoxide Dismutase (SOD1) Plasma Levels Have Significantly Lower Number of Postoperative Analgesic Oxycodone Doses: A Prospective Study with Special Reference to Cancer Patients.

BACKGROUND/AIM: Oxidative stress biomarker superoxide dismutase (SOD1) plasma levels in operated gallstone patients versus cancer patients are unknown. In addition, the number of analgesic doses during the first 24 h postoperatively (NAD24) in gallstone patients operated with laparoscopic cholecystectomy (LC) or minicholecystectomy (MC) is unreported. The aim of the study was to determine a correlation between the plasma SOD1 levels in the LC and MC patients versus cancer patients. PATIENTS AND METHODS: Initially, 114 patients with symptomatic gallstone disease were randomized into LC (n=54) or MC (n=60) groups. The plasma levels of the SOD1 marker were measured just before, immediately after (POP1) and 6 h after the operation (POP2). RESULTS: The median plasma SOD1 levels preoperatively and following surgery in the LC and MC patients versus cancer patients were statistically insignificant (p=0.90, p=0.88, p=0.21, respectively). The median plasma levels of SOD1 increased immediately after operation (POP1) and the postoperative elevation between the preoperative (PRE) and the POP1 values in the SOD1 marker were statistically significant (p=0.027). Then the median plasma levels of SOD1 marker decreased 6 h postoperatively (POP2) and the decrease between the POP1 and POP2 values in the SOD1 marker were statistically highly significant (p<0.001). There is a highly significant inverse correlation between the individual values of the NAD24 and plasma SOD1 values postoperatively in LC and MC patients (r=-0.335, p=0.011). CONCLUSION: The plasma SOD1 levels preoperatively and following surgery in the LC and MC patients versus cancer patients were quite similar. Cholecystectomy patients with enhanced levels of SOD1 appeared to have significantly lower number of analgesic oxycodone doses during the first 24 h postoperatively (NAD24).