RETRACTED ARTICLE: Reduction of postoperative nausea, vomiting, and analgesic requirement with dexamethasone for patients undergoing laparoscopic cholecystectomy

Background

Dexamethasone has antiemetic and analgesic effects for various types of surgery. The efficacy of dexamethasone for reducing postoperative nausea and vomiting (PONV) and analgesic requirement has never been evaluated for patients undergoing laparoscopic cholecystectomy (LC).

Methods

In a prospective, randomized, double-blind, placebo-controlled study, patients intravenously received placebo, dexamethasone 4 mg, or dexamethasone 8 mg immediately before induction of anesthesia. A standard anesthetic technique, including sevoflurane and air in oxygen, was used. Postoperatively, emetic symptoms (nausea, retching, and vomiting) and analgesic requirement were evaluated by an investigator.

Results

The study enrolled 90 patients (38 men and 52 nonpregnant women), with each treatment group comprising 30 patients. The rate of patients experiencing PONV 0–24 h after anesthesia was 60% for the dexamethasone 4 mg group (p = 0.294) and 33% for the dexamethasone 8 mg group (p = 0.01), compared with 70% for the placebo group. The need for indomethacin to relieve intolerable pain was less in the dexamethasone 8 mg group than in the placebo group (p = 0.008) or the dexamethasone 4 mg group (p = 0.029). No difference in analgesic requirement was found between the dexamethasone 4 mg group and the placebo group (p = 0.395). No clinically important adverse effects due to the study drug were observed in any group.

Conclusions

Prophylactic therapy with dexamethasone 8 mg is effective in reducing PONV and analgesic requirement for patients undergoing LC.     

The efficacy of single-dose postoperative intravenous dexamethasone for pain relief after endoscopic submucosal dissection for gastric neoplasm

Background

Endoscopic submucosal dissection (ESD) is the gold standard technique for en bloc resection of large superficial tumors in the upper and lower gastrointestinal tract. Little is known about the management of epigastric pain after ESD of gastric neoplasms. This study investigated the utility and safety of single-dose, perioperative, intravenous dexamethasone for epigastric pain relief following ESD.

Methods

The efficacy of intravenous dexamethasone 0.15 mg/kg (DEXA group) compared with saline-only placebo (placebo) for epigastric pain after ESD of early gastric neoplasms was assessed in a double-blinded, placebo-controlled trial. Patients completed a questionnaire about present pain intensity (PPI) and short-form McGill pain (SF-MP) categories for immediate and 6-, 12-, and 24-h postoperative periods. The primary outcome variable was PPI at 6 h following ESD. Secondary outcome variables included pain medication, SF-MP scores, complications, second-look endoscopic findings, and length of stay.

Results

A total of 36 patients participated in the study. The mean 6-h PPI value was lower (p < 0.001) in the DEXA group (1.61 ± 0.21) than in the placebo group (2.66 ± 0.19). The total 6-h SF-MP score, especially the sensory domain, was higher (p = 0.054) in the placebo group (11.56 ± 0.75) than in the DEXA group (8.89 ± 0.75). Tramadol for epigastric pain relief was more frequent (p = 0.026) in the placebo group (44.4 %) than in the DEXA group (11.1 %). No differences were noted between groups in length of stay or complications, including acute or delayed bleeding. The distribution of artificial ulcer patterns at 48-h post-ESD as determined by second-look endoscopy was similar in both groups.

Conclusion

Single-dose perioperative intravenous dexamethasone after ESD effectively relieved epigastric pain 6 h postoperatively.     

Proper preparation to reduce endoscopic reexamination due to food residue after distal gastrectomy for gastric cancer

Background

Reducing food residue by proper preparation methods before endoscopy after distal gastrectomy can increase the quality of examination and decrease patient discomfort. We evaluated the risk factors for food residue and proper methods of preparation for endoscopy after distal gastrectomy.

Methods

Follow-up endoscopy with questionnaires was performed on 1,001 patients who underwent distal gastrectomy at Asan Medical Center between December 2010 and July 2011.

Results

Endoscopic examination failed in 94 patients (9.4 %) as a result of large amounts of food residue. Rates of failure were significantly higher in patients who ate a regular diet rather than a soft diet at last dinner before examination (13.9 vs. 6.1 %, p = 0.050), and in those who ate lunch rather than not eating lunch on the day before examination (14.6 vs. 7.7 %, p = 0.020). Multivariate analysis showed that the rate of failed examination was lower in patients who had a history of abdominal surgery (p = 0.011), those who ate a soft (p < 0.001) or liquid (p = 0.003) diet as a last meal rather than a regular diet, those who underwent Billroth I rather than Billroth II reconstruction (p = 0.035), patients with longer fasting time (p = 0.009), and those with a longer gastrectomy-to-endoscopy time interval (p < 0.001).

Conclusions

Patients who undergo follow-up endoscopy after surgery should fast more than 18 h and ingest a soft or liquid diet on the day before examination.     

A prospective, randomized, double-blind study to compare the efficacy of lidocaine + metoclopramide and lidocaine + ketamine combinations in preventing pain on propofol injection

Purpose

Propofol injection is known to cause distressing pain, and various methods have been used to decrease this pain. We investigated the efficacy of the lidocaine + metoclopramide and lidocaine + ketamine combinations on modulating propofol injection pain.

Methods

Ninety ASA I/II patients aged 20–60 years were randomly assigned to three groups to receive lidocaine 20 mg (group L), lidocaine 20 mg + metoclopramide 10 mg (group LM), or lidocaine 20 mg + ketamine 5 mg (group LK), respectively, with venous occlusion for 1 min using a forearm tourniquet. Propofol 0.5 mg/kg was subsequently administered into a dorsal hand vein, and pain was assessed during its injection using a verbal rating score. The results were analyzed statistically with analysis of variance, the chi-square test, and the Wilcoxon rank sum test, where appropriate. The significance level was set at p < 0.05.

Results

The incidence of pain was rated to be significantly less in patients in groups LM (40 %) and LK (6.7 %) than in those in group L (83.3 %) (p = 0.001 and p < 0.001, respectively). The pain score [median (range)] was also significantly less in patients in groups LM [0 (0–3)] and LK [0 (0–2)] than in those in group L [2 (0–3)] (p = 0.001 for both groups).

Conclusion

The lidocaine–ketamine combination is most effective for decreasing the pain on propofol injection.     

Urodynamic effects of the combination of tamsulosin and daily tadalafil in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, placebo-controlled clinical trial

Objectives

To evaluate the effect of association of tamsulosin/tadalafil taken daily compared with tamsulosin/placebo in the lower urinary tract with urodynamic study (UDS).

Methods

All patients underwent baseline UDS before randomization to tamsulosin 0.4 mg/tadalafil 5 mg (Group 1; n = 20) or tamsulosin 0.4 mg/placebo (Group 2; n = 20) once daily for 30 days. End-of-study UDS were performed on completion of the treatment period. The primary end point was to demonstrate changes in urodynamic variables in the voiding phase, detrusor pressure at maximum flow (PdetQmax), and maximum flow rate (Qmax), from baseline to week four.

Results

The primary outcome measure of this clinical trial, PdetQmax, showed a significant reduction in tamsulosin/tadalafil group (13 ± 17.0) compared to tamsulosin/placebo (?1.2 ± 14.35) group (P = 0.03). Qmax increased in both groups, tamsulosin/tadalafil (1.0 ± 2.4) and tamsulosin/placebo (1.4 ± 2.4), but the difference was not significant between treatment groups (P = 0.65). Total IPSS, storage, and voiding sub-score improved significantly in tamsulosin/tadalafil compared with tamsulosin/placebo group.

Conclusions

The association of tamsulosin/tadalafil reduces detrusor pressure at maximum flow without changing the maximum flow rate during micturition and significantly improves lower urinary tract symptoms compared with the isolated use of tamsulosin.     

Efficacy of Cholestyramine Ointment in Reduction of Postoperative Pain and Pain during Defecation after Open Hemorrhoidectomy: Results of a Prospective, Single-center, Randomized, Double-blind, Placebo-controlled Trial

Background

The aim of the present study was to evaluate the efficacy of cholestyramine ointment (15 %) in reducing postoperative pain at rest and during defecation after open hemorrhoidectomy.

Methods

A total of 91 patients with third and fourth degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either cholestyramine ointment or placebo immediately after surgery, 12 h after surgery, and then every 8 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of tramadol consumption.

Results

The cholestyramine group had less postoperative pain than the placebo group at the 24th hour (1.84 ± 2.54 vs. 4.07 ± 3.35; P = 0.001) and 48th hour (0.18 ± 0.88 vs. 3.57 ± 3.45; P < 0.001) and less pain during defecation starting at the 48th hour (2.28 ± 2.96 vs. 4.77 ± 4.09; P = 0.001). Similarly, the average tramadol consumption at hours 24 and 48 was significantly lower for the cholestyramine group (5.32 ± 21.45 vs. 43.18 ± 61.56 mg at 24 h, and 4.48 ± 16.65 vs. 57.63 ± 65.47 mg at 48 h; P < 0.001). The only adverse event was pruritus, which had a lower frequency in the cholestyramine group but the difference was not significant until postoperative week 4 (P < 0.001).

Conclusions

Compared with placebo, cholestyramine ointment (15 %) reduced postoperative pain at rest and on defecation, and consequently lowered the analgesic requirement after open hemorrhoidectomy.     

Different factors predict CentraLoc and Intrafix fixation of quadruple hamstring allografts in low density cadaveric tibiae

Background

When using a quadruple semitendinosus–gracilis (STG) graft for ACL reconstruction tibial fixation is often the weak link. This study attempted to determine the relationship between perceived quadruple STG graft-tibial tunnel fixation quality using either a CentraLoc or an Intrafix device in cadaveric tibiae and biomechanical test performance. Within group perceived fixation quality relationships with bone mineral density (BMD), allograft diameter, and device insertion torque were also evaluated.

Methods

Using a 0–10 point modified visual analog scale a senior orthopedic surgery resident rated perceived fixation quality following specimen preparation. Constructs then underwent 500 cycles between 50 and 250 N prior to load to failure testing (20 mm/min).

Results

Only the CentraLoc device group withstood mean forces comparable to those experienced by the ACL during routine activities of daily living without failing (448.4 ± 171 N vs. 338.4 ± 119 N, P = 0.04). Perceived fixation quality using the CentraLoc device correlated strongly with tibial BMD (r ² = 0.91), but insignificantly with insertion torque or allograft diameter. CentraLoc device fixation quality prediction accuracy was fair for displacement during cyclic (r ² = 0.68) and load to failure (r ² = 0.65) biomechanical test performance. The Intrafix device displayed fair perceived fixation quality relationships with insertion torque (r ² = 0.76) and allograft diameter (r ² = 0.70) but not with tibial BMD. Intrafix device fixation quality prediction accuracy was fair for load to failure (r ² = 0.63), but insignificant for displacement during cyclic biomechanical test performance.

Conclusions

In cadaveric tibiae with poor cancellous trabecular bone density, the CentraLoc device provided more predictable and better quadruple STG allograft fixation than the Intrafix device.     

Comparison of the effects of dexmedetomidine, ketamine, and placebo on emergence agitation after strabismus surgery in children

Background

Children undergoing strabismus surgery under sevoflurane anesthesia often experience emergence agitation (EA) and postoperative vomiting (POV). This study compared the effects of intraoperative dexmedetomidine, ketamine, and placebo on postoperative EA and POV.

Methods

Eighty-four children (aged two to seven years) undergoing elective strabismus surgery under sevoflurane anesthesia were randomly assigned to one of three groups (n = 28 each). Intraoperatively, the placebo, dexmedetomidine, and ketamine groups received normal saline, dexmedetomidine 1 μg·kg^?1 iv plus a 1 μg·kg^?1·hr^?1 infusion, and ketamine 1 mg·kg^?1 iv plus a 1 mg·kg^?1·hr^?1 infusion, respectively. Agitation scores (Pediatric Anesthesia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU) and for 24 hr on the ward. Pain scores and times to laryngeal mask airway (LMA?) removal, resumption of mental orientation, and discharge from the PACU were also assessed.

Results

Seventy-eight children completed the study. Peak PAED scores for EA were lower in the dexmedetomidine (P < 0.001) and ketamine (P = 0.002) groups than in the placebo group. Incidence of POV was lower in the dexmedetomidine group (15%) than in the ketamine (44%; P = 0.02) or placebo (45.8%; P = 0.02) groups. Pain scores on the ward were lower in the dexmedetomidine (P < 0.001) and ketamine (P < 0.001) groups than in the placebo group. Time to LMA removal was similar in all groups. Time for resumption of mental orientation and time to discharge from PACU were longer in the dexmedetomidine and ketamine groups than in the placebo group.

Conclusions

Dexmedetomidine and ketamine appear to prevent postoperative agitation and pain after sevoflurane anesthesia for pediatric strabismus surgery. Dexmedetomidine also prevents POV.     

Strontium ranelate prevents quality of life impairment in post-menopausal women with established vertebral osteoporosis

Summary

Strontium ranelate reduces the risk of fracture in post-menopausal osteoporotic women with prevalent fractures for whom quality of life is severely impaired. The SOTI study, which used the SF-36® questionnaire and disease-specific QUALIOST® module, demonstrated that treatment with strontium ranelate improved osteoporotic women’s quality of life compared with placebo.

Introduction

The Spinal Osteoporosis Therapeutic Intervention (SOTI) study demonstrated the effect of orally administered strontium ranelate versus placebo on the incidence of new vertebral fractures and compared impact on quality of life (QoL).

Methods

QoL was assessed 6 monthly over 3 years using the QUALIOST® and SF-36® questionnaires in post-menopausal osteoporotic women with prevalent fracture taking strontium ranelate or placebo 2 g/day. A total of 1,240 women were included (strontium ranelate: n?=?618 and placebo: n?= 622).

Results

The QUALIOST® total score decreased in the strontium ranelate group, indicating preserved QoL compared with a deterioration in the placebo group (P?=?0.016). Strontium ranelate patients had reduced QUALIOST® emotional and physical dimension scores (P?=?0.019 and 0.032, respectively, versus placebo), indicating beneficial effects on emotional and physical functioning. There was a trend towards better SF-36® scores in the strontium ranelate group, although there were no significant between-group differences. More strontium ranelate patients (+ 31%) were free from back pain over 3 years versus placebo (P?=?0.005), with a significant effect from the first year of treatment (P?=?0.023).

Conclusion

Strontium ranelate has beneficial effects on QoL in women with post-menopausal osteoporosis compared with placebo.     

Efficacy of antibiotic prophylaxis in patients undergoing cystoscopy: a randomized clinical trial

Objective

To establish the efficacy of antibiotic prophylaxis prior to cystoscopy in outpatients in decreasing the incidence of post-procedure urinary tract infection.

Study design and setting

A randomized clinical trial in patients (men and women) older than 18 who underwent cystoscopy for any non-urgent indication. The intervention was Levofloxacin 500 mg single dose, and the control was placebo 500 mg single dose made with similar characteristics. The primary outcome was urinary tract infection (UTI) measured 3–10 days after the procedure. It was performed as per protocol analysis.

Results

Hundred and thirty-eight patients in each study arm completed the trial. The incidence of UTI in the intervention group was 0.7 % and in the placebo group was 3 % (p = 0.17), and no significant differences were found. The incidence of asymptomatic bacteriuria in the intervention group was 5.8 % and in the control group was 14.5 % (p = 0.01).

Conclusions

No significant differences were found in the use of prophylactic antibiotic compared to placebo to reduce the incidence of UTI in patients who undergo cystoscopy as an outpatient procedure with sterile urine demonstrated by urine culture.     

A comparative study on the use of tamsulosin versus alfuzosin in spontaneous micturition recovery after transurethral catheter removal in patients with benign prostatic growth

Purpose

To compare the efficacy and safety of tamsulosin and alfuzosin in patients with acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH).

Methods

Ninety men with AUR due to BPH underwent urinary catheterization and were randomly assigned to treatment groups with tamsulosin 0.4 mg (37 patients), alfuzosin 10 mg (34 patients), and placebo (19 patients). After 4 days of the drug treatment, the catheters were removed, and the patients underwent trial without catheter (TWOC). A TWOC was considered successful if the patient had a voided volume >100 ml and post-void residual urine <200 ml.

Results

TWOC was successful in 16 patients (43.2 %) in the tamsulosin group, 12 patients (35.2 %) in the alfuzosin group, and 5 patients (26.3 %) in the placebo group. Logistic regression analysis showed that both drugs were equally effective and that the type of alpha-blocker was not a predictive factor for TWOC success (OR 1.137, 95 % CI 0.639–2.022) (p = 0.662).

Conclusion

Even though there were no statistically significant differences when comparing the three groups, tamsulosin showed a tendency to be more effective in a successful catheter removal. The lack of objective criteria in the definition of successful micturition leads us to believe that the effectiveness of both drugs reported in the literature is overestimated.     

Risk factors of residual or recurrent tumor in patients with a tumor-positive resection margin after endoscopic resection of early gastric cancer

Background

In cases with a tumor-positive resection margin after endoscopic resection of early gastric cancer (EGC), not all patients are found to have residual or recurrent tumor. The aim of this study was to identify risk factors associated with residual/recurrent tumor in patients with incomplete endoscopic resection of EGC.

Methods

A retrospective analysis was performed on consecutive patients who underwent endoscopic resection of EGC at a single institution in South Korea. Patients with a tumor-positive resection margin in the specimen were divided into two groups, with and without residual/recurrent tumor, and the clinicopathologic characteristics were compared.

Results

A total of 102 patients with a tumor-positive lateral or vertical resection margin after endoscopic mucosal resection (n = 10) or submucosal dissection (n = 92) were enrolled. Overall, the rate of residual/recurrent tumor was 33.3 % (34/102): 17 residual tumors in 46 patients who immediately underwent additional endoscopic or surgical resection, and 17 recurrent tumors in 56 patients who were initially followed up with regular endoscopy during a median period of 17 (range = 2–70) months. Univariate analysis showed that the presence of ulcer, the direction of the tumor-positive resection margin, and length of lateral resection margin involvement by the tumor were associated with the incidence of residual/recurrent tumor. In multivariate analysis, total length (cm) of lateral resection margin involvement was the only independent risk factor for residual/recurrent tumor (OR 2.05; 95 % CI 1.22–3.44, p = 0.006).

Conclusions

Patients with extensive tumor involvement of a lateral resection margin after endoscopic resection of EGC should consider additional endoscopic or surgical resection due to a high risk of residual/recurrent tumor.     

Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective,double-blind,placebo-controlled study

Purpose

Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally immunostimulating agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

Methods

Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo.

Results

Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p = 0.59; PPS: p = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa.

Conclusions

This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated.

EudraCT

2007-004609-85.     

Efficacy and safety of SBR759, a novel calcium-free,iron (III)-based phosphate binder,versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy

Background

SBR759, an iron (III)-based oral phosphate binder, was developed for the treatment of hyperphosphataemia in chronic kidney disease stage V patients receiving maintenance renal replacement therapy (RRT). Serum phosphate-lowering efficacy and dose response of SBR759 (3-, 6-, 9- and 12-g/day doses) were compared with placebo.

Methods

Japanese patients with hyperphosphataemia (P ≥ 5.5 mg/dL [≥1.78 mmol/L]) receiving maintenance RRT (N = 63) were randomised to receive either SBR759 (3-, 6-, 9-, 12-g/day dose) or placebo (12-g/day dose) for 4 weeks. The primary endpoint was change from baseline in 72-h post-dialysis serum phosphate levels at week 4 for different doses of SBR759 versus placebo. Secondary endpoints were change from baseline in serum phosphate levels and dose-dependent efficacy of SBR759 during the 4-week treatment period.

Results

SBR759 showed significant reduction in serum phosphate levels compared with placebo at week 4, demonstrating a significant linear dose response (P < 0.001). Incidence of adverse events was comparable between the SBR759 treatment groups (7/13 and 5/12 in the 3- and 12-g/day groups, respectively, and 8/13 in the 6- and 9-g/day groups) and was 6/12 in the placebo group. Discoloured faeces and diarrhoea were the most frequently reported adverse events. Two serious adverse events were reported—one in the SBR759 3-g/day group (1/13, skin ulcer) and one in the SBR759 12-g/day group (1/12, arthralgia).

Conclusions

SBR759 showed significant phosphate-lowering efficacy and dose-dependent response compared with placebo in patients with chronic kidney disease receiving RRT.     

A phase II dose-ranging study of mirabegron in patients with overactive bladder

Introduction and hypothesis

Mirabegron is a potent and selective β₃-adrenoceptor agonist that may represent an alternative treatment option in place of antimuscarinics for patients with overactive bladder.

Methods

Patients completed a single-blinded, 2-week placebo run-in period followed by 12 weeks of randomized (n?=?928) double-blinded treatment with mirabegron oral controlled absorption system (OCAS) 25, 50, 100, or 200 mg once-daily (QD), placebo or tolterodine extended release (ER) 4 mg QD. The primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes/24 h. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes/24 h; severity of urgency; nocturia; and quality of life measures. Safety parameters included vital signs, adverse events, laboratory tests, electrocardiogram measurements and post-void residual volume.

Results

Mirabegron 25, 50, 100, and 200 mg resulted in dose-dependent reductions (improvements) from baseline to end-of-treatment in micturition frequency of 1.9, 2.1, 2.1, and 2.2 micturitions/24 h respectively, versus 1.4 micturitions/24 h with placebo (p?≤?0.05 for the mirabegron 50-, 100-, and 200-mg comparisons). There was a statistically significant improvement with mirabegron compared with placebo for most secondary endpoints including quality of life variables. While there was a significant (p?<?0.05) increase from baseline in pulse rate in the mirabegron 100-mg and 200-mg groups, this was not associated with an increased incidence of cardiovascular adverse events.

Conclusions

The favorable efficacy and tolerability of mirabegron in this phase II dose-finding study has led to its successful advancement into a phase III clinical development program.     

Timing and Pattern of Recurrence in Ovarian Cancer Patients with High Tumor Dissemination Treated with Primary Debulking Surgery Versus Neoadjuvant Chemotherapy

Purpose

To compare the timing and pattern of recurrence in patients with advanced ovarian cancer (AOC) receiving primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS).

Methods

We retrospectively evaluated a consecutive series of 175 stage IIIC–IV epithelial ovarian cancer patients, with diffuse peritoneal carcinomatosis documented at initial surgical exploration. Forty patients received complete PDS, and the remaining 135 were treated with NACT followed by IDS with absent residual tumor after surgery.

Results

No differences were observed in the distribution of clinical pathological characteristics at the time of diagnosis between the two groups. The median follow-up was 31 months (range 9–150 months). We observed 20 (50.0 %) recurrences in the PDS group compared to 103 (76.3 %) in the IDS group (p = 0.001). Duration of primary platinum-free interval (PFI) was shorter in IDS compared to PDS group (13 vs. 21 months, respectively; p = 0.014). A significantly higher percentage of patients in the IDS group experienced platinum-resistant recurrences (35.9 vs. 5.0 %; p = 0.006) and carcinomatosis at the time of relapse (57.3 vs. 20.0 %; p = 0.0021). Finally, in women with platinum-sensitive recurrence, we observed a shorter secondary PFI in the IDS compared to PDS group (p = 0.006).

Conclusions

We documented a better behavior of recurrent disease in AOC patients with diffuse peritoneal carcinomatosis treated with complete PDS compared to women submitted to NACT followed by IDS with no residual tumor after surgery.     

A Randomized, Prospective, Double-blind, Placebo-Controlled Trial of the Effect of Diltiazem Gel on Pain After Hemorrhoidectomy

Background

Spasm of the internal anal sphincter is considered to be one of the causes of pain in anal diseases. We have evaluated the effects of topical diltiazem on postoperative pain after hemorrhoidectomy.

Methods

Sixty-two patients were randomly assigned to receive a 2 % diltiazem gel (n = 32) or a placebo gel (n = 30) after hemorrhoidectomy. Patients applied the gel to the anal region three times per day for 14 days. Pain both in the resting state and on defecation ranged from 0 to 10 on a numerical rating scale, and the number of prescribed loxoprofen tablets (Loxonin) were recorded and confirmed daily by telephone. Any morbidity during the follow-up period was recorded.

Results

Both pain scores during defecation and the number of analgesic tablets consumed tended to be lower in the diltiazem group, although they did not reach statistical significance (P = 0.09, P = 0.12, respectively). Total number of complications was significantly higher in the diltiazem group, but each incidence of complications, including itching sensation, headache, and dizziness was not statistically different.

Conclusions

Perianal application of 2 % diltiazem gel after hemorrhoidectomy has the potential to reduce postoperative pain during defecation.     

Characteristics and significance of fever during 4 weeks after primary total knee arthroplasty

Purpose

Most previous studies on postoperative fever (POF; ≥38 °C) after total knee arthroplasty (TKA) have reported findings from only the immediate postoperative days (PODs). The hypothesis of the current study is that 4 weeks of follow-up may reveal differences in the characteristics of POF and fever-related factors between a normal inflammatory response and an early acute infection-related response.

Methods

A total of 400 consecutive TKAs (314 patients) were retrospectively investigated. Patients were stratified into those who developed an early acute periprosthetic infection that required subsequent surgical treatment (STG; n = 5 TKAs) and those who did not (non-STG; n = 395 TKAs).

Results

Among the 400 knees, 149 (37 %) developed POF, with most reaching a maximum temperature (MT) on POD 0. In 13 TKA patients who had POF with a peak daily temperature ≥38 °C during postoperative weeks 2–4, the causes of POF were respiratory and urinary tract infections (n = 5 for each), superficial infection (n = 2), and periprosthetic infection (n = 1). The STG and non-STG differed significantly with regard to the rate of POF (p = 0.0205) and MT (p = 0.0003), including MTs less than 38 °C, during postoperative weeks 2–4. All five STG patients had elevated C-reactive protein levels and local symptomatic findings before the additional surgery.

Conclusions

The occurrence of POF and MT along with elevated C-reactive protein and local symptomatic findings at 2–4 weeks postoperatively may indicate the need for a positive fever workup to recognize early acute periprosthetic infection.     

Dexmedetomidine impairs success of patient-controlled sedation in alcoholics during ERCP: a randomized, double-blind, placebo-controlled study

Background

There is a lack of studies about procedural sedation of alcoholics. Dexmedetomidine is recommended for procedural sedation and reported effective for alcohol withdrawal. We evaluated the suitability of dexmedetomidine for sedation of alcoholics during endoscopic retrograde cholangiopancreatography (ERCP).

Methods

Fifty patients with chronic alcoholism scheduled for elective ERCP were randomized 1:1 to receive dexmedetomidine (Dex group) (loading dose 1 μg kg^?1 over 10 min, followed by constant intravenous infusion 0.7 μg kg^?1 h^?1) or saline placebo (P group). Patient-controlled sedation with propofol–alfentanil was used by patients as a rescue method. Sedation was considered as successful if no intervention of an anesthesiologist was needed. Consumption of sedatives was registered, and sedation levels and vital signs were monitored.

Results

Dexmedetomidine alone was insufficient in all patients. The mean ± SD consumption of propofol was 159 ± 72 mg in the P group, and 116 ± 61 mg in the Dex group (p = 0.028). Sedation was successful in 19 of 25 (76 %) patients in the Dex group and in all patients in the P group (p = 0.022). The incidence of sedation adverse events did not differ between the groups. Dexmedetomidine was associated with delayed recovery.

Conclusions

Patient-controlled sedation with propofol and alfentanil but not dexmedetomidine can be recommended for sedation of alcoholics during ERCP.     

Magnetic Resonance Imaging and Ultrasonography in Predicting Infiltrating Residual Disease after Preoperative Chemotherapy in Stage II–III Breast Cancer

Background

This study was designed to evaluate the accuracy of breast magnetic resonance imaging (MRI) and ultrasonography (US) in predicting the extent of breast residual disease after preoperative chemotherapy.

Methods

Patients with stage II–III invasive breast tumors who received preoperative chemotherapy and were imaged with post-treatment MRI were included. Histopathological verification was available for all patients. The longest diameter of residual tumor measured with MRI and US has been compared with the infiltrating residual tumor size at pathologic evaluation.

Results

A total of 108 patients were enrolled: 59 were imaged with both MRI and US (MRI group), and 49 were imaged with US only (non-MRI group). The non-MRI group was enrolled as an external control to avoid possible bias in the selection of patients. In the MRI group, the means of the deltas between MRI residual tumor size and pathologic size and between US and pathologic size were 0.16 cm and ?0.06 cm respectively (P = not significant). Overall, a discrepancy limited in the interval from ?0.5 cm to +0.5 cm compared with the pathologic size was observed in 54% and 51% of the patients with MRI and US, respectively (P = not significant). The linear correlation between the radiological measurement and pathologic tumor size was r = 0.53 for MRI and r = 0.66 for breast US. In the non-MRI group, the mean of the deltas between US residual tumor size and pathologic size was 0.06 cm, and the linear correlation was r = 0.79.

Conclusions

In this series of patients, MRI and US do not show significant differences in predicting the breast residual infiltrating tumor after preoperative chemotherapy.