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.

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.

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.

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).

Patients with Increased Levels of the Oxidative Stress Biomarker SOD1 Appear to Have Diminished Postoperative Pain After Midline Laparotomy: A Randomised Trial with Special Reference to Postoperative Pain Score (NRS).

BACKGROUND/AIM: The levels of the oxidative stress biomarker superoxide dismutase (SOD1) in plasma in relation to pain at rest 24 hours after (NRS24) midline laparotomy in patients with rectus sheath block (RSB) analgesia is unknown. PATIENTS AND METHODS: Initially, 56 patients (39 with cancer), each with an intravenous oxycodone pump as patient-controlled analgesia, were randomized to four groups: control group, no RSB (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) of RSB analgesia. The plasma levels of SOD1 were measured directly before, immediately after and 24 hours after surgery. Pain at rest was scored on an 11-point numeric rating scale 24 hours postoperatively (NRS24: 0=no pain to 10=worst pain). RESULTS: The median plasma level of SOD1 increased immediately after operation and this was statistically highly significant (p=0.007). The median plasma level of SOD1 then decreased 24 hours postoperatively and this postoperative decrease was also statistically highly significant (p<0.001). The median plasma levels of SOD1 did not differ significantly between patients with benign disease and those with cancer, preoperatively and after surgery. There was highly significant positive correlation between SOD1 and glutathione peroxidase (GPX1) values postoperatively (r=0.67, p<0.001) and a trend for an inverse correlation between the individual values of the NRS24 and plasma SOD1 values postoperatively in patients with benign disease and those with cancer (r=-0.30, p=0.09). CONCLUSION: Midline laparotomy significantly alters the level of oxidative stress marker SOD1 immediately after surgery, but the level normalizes 24 hours following surgery. Interestingly, patients with increased levels of SOD1 appeared to have diminished postoperative pain after midline laparotomy.

Plasma Glutathione Peroxidase (GPX1) Levels and Oxidative Stress in Gallstone Patients Operated with Two Different Cholecystectomy Techniques: A Randomized Study with Special Reference to Cancer Patients.

BACKGROUND/AIM: The plasma glutathione peroxidase (GPX1) levels in gallstone patients operated with laparoscopic cholecystectomy (LC) or minicholecystectomy (MC) versus cancer patients is unknown. PATIENTS AND METHODS: Initially, 114 patients with symptomatic gallstone disease were randomized into LC (n=53) or MC (n=61) groups. Plasma levels of C-reactive protein (hs-CRP) and the oxidative stress marker GPX1 were measured at three time points; before (PRE), immediately after (POP1) and 6 hours after operation (POP2). The end-point of our study was to determine a correlation between the plasma hs-CRP and GPX1 levels in the LC and MC patients versus cancer patients. RESULTS: The plasma GPX1 levels preoperatively and following surgery in the LC and MC patients versus cancer patients were quite similar (p=0.509, p=0.578, p=0.882, respectively). The patients with inflammation of the gallbladder wall (IGW) versus no-IGW had significantly higher plasma GPX median (interquartile range) levels preoperatively (11.5; 6.2-17.4 vs. 8.0; 5.6-14.5, p=0.033) and the GPX values following surgery (POP1, 11.4; 7.8-14.7 versus 7.3; 4.4-11.0, p=0.019 and POP2, 11.5; 7.1-16.2 versus 9.4; 4.2-13.1, p=0.027). The IGW in patients with LC and MC groups combined, correlated significantly to the plasma CRP levels preoperatively (r=0.280, p=0.005) and the CRP values following surgery (POP1, r=0.295, p=0.003 and POP2, r=0.338, p=0.001) and the GPX1 values postoperatively (POP1, r=0.319, p=0.001 and POP2, r=0.243, p=0.026) and to the length of the skin incision (r=0.248, p=0.009). CONCLUSION: The plasma GPX1 levels preoperatively and following surgery in the LC and MC patients versus cancer patients were quite similar. However, the inflammation of the gallbladder wall (IGW) correlated significantly with plasma GPX1 and hs-CRP values suggesting that inflammation and oxidative stress are related.

Does Rectus Sheath Block Analgesia Alter Levels of the Oxidative Stress Biomarker Glutathione Peroxidase: A Randomised Trial of Patients with Cancer and Benign Disease.

AIM: To evaluate whether the overall satisfaction, as measured by numeric rating scale (NRS), regarding rectus sheath block (RSB) analgesia is associated with the plasma glutathione peroxidase (GPX1) level. The second end-point of the study was to evaluate the differences in GPX1 levels in patients with and without RSB analgesia, with special emphasis on benign or malign disease status. PATIENTS AND METHODS: Initially, 56 patients were randomized to the placebo group (n=12) and to one of three active RSB analgesia groups: single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) groups. The plasma level of GPX1 was measured at three time points: just before, immediately after and 24 h after surgery. The overall satisfaction and an opinion on the success of the analgesic procedure were surveyed using an 11-point numeric rating scale 24 h postoperatively (NRS from 0, completely dissatisfied, to 10, fully satisfied). RESULTS: The placebo group and the three active groups were similar in terms of their perioperative data. The plasma level of GPX1 decreased postoperatively in all four groups. No differences were detected in the GPX1 values between the placebo and the three active groups combined preoperatively and immediately after operation. However, the patients in the single-dose group had a significantly lower median GPX1 values 24 h after surgery compared to the three other groups separately (p=0.032). The median (interquartile range) plasma level of GPX1 differed significantly between patients with benign disease and those with cancer preoperatively (18.0, 12.5-22.0 versus 10.0, 6.3-18.8 pg/ml, p=0.006) and cancer diagnosis was correlated with lower individual plasma GPX1 values (r=-0.42, p=0.004). CONCLUSION: The placement of RSB analgesia does not significantly affect the level of oxidative stress biomarker GPX1 in patients with benign disease or cancer. A new finding with possible clinical relevance is that patients with cancer appeared to have a trend for lower plasma GPX1 values.

Improvement in the quality of life following cholecystectomy: a randomized multicenter study of health status (RAND-36) in patients with laparoscopic cholecystectomy versus minilaparotomy cholecystectomy.

PURPOSE: The assessment of the quality of life (QoL) in minilaparotomy cholecystectomy (MC) versus laparoscopic cholecystectomy (LC) with the ultrasonic dissection in both groups has not been addressed earlier. METHODS: Initially, 109 patients with non-complicated symptomatic gallstone disease were randomized to undergo either MC (n = 59) or LC (n = 50). RAND-36 survey was conducted preoperatively and at 4 weeks and 6 months postoperatively. The end point of our study was to determine differences in health status in MC versus LC groups. RESULTS: QoL improved significantly in both groups, and the recovery was similar in the two groups, except from the higher score in 'health change' subscale at 4 weeks in MC group [MC score 75.0 (25.0) vs. LC score 56.5 (23.2), p = 0.008]. The MC and LC groups combined, RAND-36 scores increased significantly in 'physical functioning' [combined mean (SD) preoperative score 80.5 (23.9) vs. 6-month postoperative score 86.5 (21.7), p = 0.015], 'vitality' [64.5 (19.2) vs. 73.5 (18.3), p = 0.001], 'health change' [43.0 (21.6) vs. 74.6 (25.4), p = 0.0001] and 'bodily pain' scores [57.7 (26.3) vs. 75.5 (25.5), p = 0.001], respectively. Four RAND-36 domains indicated statistically significant health status differences in comparing the preoperative and postoperative RAND-36 scores in LC and MC groups combined. CONCLUSIONS: Four RAND-36 domains indicated a significant positive change in QoL after cholecystectomy.