Should we train the trainers? Results of a randomized trial

BACKGROUND: The development of efficient training methods in surgery is increasingly important. The effectiveness of training trainers is unclear. This study was designed to determine the effect on their trainees' performance of instructing trainers in a specific cognitive training method. STUDY DESIGN: Ten trainers from a university teaching hospital were randomized to train novices on a one-to-one basis in a simulated procedure using either a four-step cognitive method or their own unspecified method. Thirty trainees were randomly assigned to either a cognitive or standard trainer. After training, trainees were assessed on performing the procedure using a task-specific checklist, a global rating scale, and time taken to complete the procedure. RESULTS: Trainees who were trained using the specific cognitive method completed the procedure in a faster time (mean 331 seconds [SD 37 seconds] versus 426 seconds [SD 66 seconds]) and with higher global rating scores (mean 23.25 seconds [SD 3.7 seconds] versus 20.5 seconds [SD 4.5 seconds]) compared with those taught by a standard method. CONCLUSIONS: Instructing trainers in a cognitive training method results in a significant improvement in training outcomes.     

Bupivacaine use in the Insuflow® device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial

Background

Recent evidence [Surg Endosc (2007) 21: 602–606] demonstrates that intraperitoneal bupivacaine administered as an aerosol via a special catheter is safe and significantly decreases postoperative pain in laparoscopic surgery. We currently use the Insuflow^® device (Lexion Medical) routinely to warm and humidify gas in laparoscopic surgery. The purpose of this study is to determine whether using bupivacaine instead of water in existing technology already in use (Insuflow) will result in decreased postoperative pain, without increasing operative time or cost.

Methods

Using a double-blind methodology, 50 patients undergoing elective outpatient laparoscopic cholecystectomy were randomized to a study drug: either 10 ml of 0.5% bupivacaine (50 mg) or 10 ml of sterile water. The study drug was injected into the Insuflow in the standard fashion and the operation commenced routinely. No perioperative nonsteroidal anti-inflammatory drugs were used. Using a standard 0–10 pain-scoring scale, patients were assessed by perioperative nurses at 1 and 2 h postoperatively. Pain was again assessed at 24 h by telephone interview, along with the number of narcotic oral analgesics used in the first 24 h.

Results

Fifty patients were randomized, 25 in each group; the groups were comparable. All patients completed the study and 100% follow-up was obtained. All patients were discharged the same day and there were no significant complications in either group, and specifically no complications attributed to bupivacaine or use of the Insuflow device. There were no differences in pain at 1 and 2 h. There was less pain in the bupivacaine group at 24 h, but this was not statistically significant (P = 0.055).

Conclusions

Bupivacaine use in the Insuflow device is safe. No significant differences in postoperative pain were noted in this study compared to using water.     

Inflammatory response after laparoscopic and conventional colorectal resections – results of a prospective randomized trial

Background: Short-term benefits of laparoscopic relative to conventional colorectal resections have been demonstrated in randomized controlled trials. It has been suggested that a diminished cytokine and acute-phase response may be responsible for these advantages. Methods: In a randomized controlled trial, patients underwent laparoscopic (n=30) or conventional (n=30) resection of colorectal tumors. Plasma levels of interleukin-1 receptor antagonist (IL-1RA), interleukin-6 (IL-6), interleukin-10 (IL-10), and C-reactive protein (CRP) were analyzed repeatedly. Postoperative peak levels and area under the curve values were calculated and compared between groups using the Mann-Whitney U-test. Results: Patient characteristics, preoperative cytokine, and CRP plasma levels were not different between each group. Postoperative peak concentrations of IL-6 (P=0.05) and CRP (P<0.001) and the overall postoperative plasma concentrations of IL-6 (P=0.03) and CRP (P=0.002) were lower in the laparoscopic than in the conventional group. Peak and overall IL-1RA (P=0.2; P=0.2) and IL-10 (P=0.4; P=0.6) plasma concentrations, respectively, were not different between groups. Conclusions: IL-6 and CRP plasma levels were lower after laparoscopic than conventional colorectal resections. The less intense inflammatory response may be an indicator of the milder surgical trauma inflicted by laparoscopic than conventional colorectal resection. Received: 31 March 1999; in revised form: 15 July 1999 Accepted: 20 August 1999     

Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? results of a prospective randomized trial

Despite substantial improvements in perioperative mortality, complications, and specifically the development of a pancreatic fistula, remain a common occurrence after pancreaticoduodenectomy. It was the objective of this study to evaluate the role of fibrin glue sealant as an adjunct to decrease the rate of pancreatic fistula after pancreaticoduodenectomy. One hundred twenty-five patients were randomized after pancreaticoduodenal resection only if, in the opinion of the surgeon, the pancreaticojejunal anastomosis was at high risk for development of a pancreatic anastomotic leak. After completion of the pancreaticojejunal anastomosis, the patients were randomized to topical application of fibrin glue sealant to the surface of the anastomosis or no such application. The primary postoperative end points in this study were pancreatic fistula, total complications, death, and length of hospital stay. A total of 59 patients were randomized to the fibrin glue arm, whereas 66 patients were randomized to the control arm and did not receive fibrin glue application. The pancreatic fistula rate in the fibrin glue arm of the study was 26% vs. 30% in the control group (p = not significant [NS]). The mean length of postoperative stay for all patients randomized was similar (fibrin glue = 12.2 days, control = 13.6 days) and the mean length of stay for patients in whom pancreatic fistula developed was also not different (fibrin glue = 18.9 days, control = 21.7 days). There were no differences with respect to total complications or specific complications such as postoperative bleeding, infection, or delayed gastric emptying. These data demonstrate that the topical application of fibrin glue sealant to the surface of the pancreatic anastomosis in this patient population undergoing high-risk pancreaticojejunal anastomosis did not reduce the incidence of pancreatic fistula or total complications after pancreaticodudodenectomy. There seems to be no benefit regarding the use of this substance in this setting. Presented at the Forty-Fifth Annual Meeting of the Society for Surgery of the Alimentary Tract, New Orleans, Louisiana, May 15–19, 2004 (oral presentation). This work was supported in part by the Haemacure Company and Baxter Health Care.     

Management of intraoperative hemorrhage during NOTES®: a prospective, randomized comparison

Background

The optimal strategy to manage intraoperative hemorrhage during NOTES^® is unknown. A randomized comparison of three instruments for hemorrhage control was performed [prototype endoscopic bipolar hemostasis forceps (BELA) vs. prototype endoscopic clip (E-CLIP) applier versus laparoscopic clip (L-CLIP) applier].

Methods

A hybrid transvaginal NOTES model in swine was used, with hemorrhage induced in either the gastroepiploic (GE) arteriovenous bundle (vessel diameter ~3 mm) or in distal mesenteric vessels (vessel diameter ~1–2 mm). Hemostasis was attempted three times per vessel using each instrument in a randomized order. Full laparoscopic salvage was performed if hemorrhage persisted beyond 10 min. Outcomes included primary success rate (PS), primary hemostasis time (PHT), number of device applications (DA), and overall hemostasis time (OHT, including salvage).

Results

Seventy hemostasis attempts were made in 12 swine. PS was 42–67 % for the GE vessels, with no difference between instruments. PHT and OHT also were similar between instruments, with the BELA and L-CLIP having a higher number of DA. PS was (80–100 %) in mesenteric vessels, with the BELA and L-CLIP resulting in a shorter mean PHT compared with the E-CLIP.

Conclusions

All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1–2 mm) in a porcine model is effective using all three instruments but may be most efficient with the BELA or L-CLIP. Large vessel bleeding (≥3 mm) may be best managed by adding laparoscopic ports for assistance while maintaining a low threshold for conversion to full laparoscopy.     

When should we discontinue antiarrhythmic therapy for atrial fibrillation after coronary artery bypass grafting? A prospective randomized study

BACKGROUND: New-onset atrial fibrillation after coronary artery bypass grafting is common. Medical therapy includes various antiarrhythmic drugs to control heart rate and restore sinus rhythm. The purpose of this study was to determine the duration of antiarrhythmic therapy after discharge from the hospital. METHODS: One hundred twenty-nine patients in whom new atrial fibrillation after coronary artery bypass grafting developed and successfully reverted to sinus rhythm were prospectively randomized at dismissal to receive antiarrhythmic therapy for 1 week (group A; n = 44), 3 weeks (group B; n = 42), or 6 weeks (group C; n = 43). Patients were followed up for an additional 4 weeks after discontinuation of antiarrhythmic therapy for detection of recurrent atrial fibrillation. RESULTS: The incidence of new atrial fibrillation during the study period was 21.2% (256/1206). Among the 129 patients who consented to the study, conversion to sinus rhythm was accomplished with the following medications: amiodarone (group A, 82%; group B, 93%; group C, 88%; P = .29), digoxin (group A, 16%; group B, 7%; group C, 7%; P = .29), beta-blockers (group A, 27%; group B, 19%; group C, 14%; P = .30), calcium channel blockers (group A, 2%; group B, 2%; group C, 0%; P = .60), quinidine (group A, 2%; group B, 2%; group C, 7%; P = .44), and procainamide (group A, 4.5%; group B, 2%; group C, 0%; P = .37). Follow-up was completed in 128 patients (99.2%). There was no significant difference in the recurrence of atrial fibrillation among groups (0%, 2%, and 0% for groups A, B, and C, respectively). CONCLUSIONS: Patients with new atrial fibrillation after coronary artery bypass grafting, converted to normal sinus rhythm before hospital discharge, have a benign course. Antiarrhythmic therapy as short as 1 week may be appropriate in these patients.     

Laparoscopic versus open appendectomy: What is the real difference? Results of a prospective randomized double-blinded trial

Background: The comparison of laparoscopic to open appendectomy has been reviewed in many retrospective and prospective studies. Some report shorter hospital stays, less postoperative pain, and earlier return to work while others fail to demonstrate such differences. We performed a prospective, randomized double-blinded trial to evaluate this ongoing debate. Methods: Fifty-two consecutive men presenting with signs and symptoms suggestive of acute appendicitis were randomized to undergo either laparoscopic appendectomy or open appendectomy. Length of operative times, hospital stay, lost work days, visual analog pain scores, and operative costs were compared. Results: Length of stay averaged 21.5 h for the laparoscopic group and was not statistically different when compared to the open group. Perceived postoperative pain on postoperative days 1 and 7 were not statistically different between the two groups. Mean time to return to work was 11 days, and there was no statistical difference between groups. Operative costs were >$600 greater for the laparoscopic approach. Conclusions: In this prospective randomized double-blinded trial, laparoscopic appendectomy appears to confer no significant advantage over open appendectomy for postoperative pain or lost work days. It does carry an increase in operating room costs and, contrary to other reports, hospital stay is not shortened. Further studies are needed to determine if specific populations, such as the obese or women, may benefit from a minimally invasive approach to appendicitis. The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government     

Complicated appendicitis: is there a minimum intravenous antibiotic requirement? A prospective randomized trial

The proper duration of postoperative intravenous (IV) antibiotics in patients suffering complicated (perforated or gangrenous) appendicitis is debatable. Some advocate a set minimum number of IV antibiotic days whereas others discontinue IV antibiotics depending on the patient's clinical course regardless of the length of therapy. Our objective was to determine whether there are differences in morbidity and resource utilization between the two treatment methodologies. Ninety-four patients with intraoperative findings of complicated appendicitis were included. In all patients IV antibiotics were discontinued on the basis of clinical factors. However, Group 1 patients were given a minimum 5-day IV antibiotic course whereas Group 2 patients had no minimum IV antibiotic requirement. Group 1 patients received more IV antibiotics than Group 2 patients did (5.9 vs 4.3 days; P = 0.014). Infectious complications were not statistically different between the two groups (13.0% in Group 1 and 12.5% in Group 2). Average hospital stay was also not statistically different between the two groups. The data suggest that a protocol with no minimum IV antibiotic requirement in patients with complicated appendicitis does not increase morbidity. Furthermore, the protocol arm with no minimum IV antibiotic requirement led to less IV antibiotic use but did not significantly decrease hospital stay.     

Endpoints of resuscitation of critically injured patients: normal or supranormal? A prospective randomized trial

OBJECTIVE: To evaluate the effect of early optimization in the survival of severely injured patients. SUMMARY BACKGROUND DATA: It is unclear whether supranormal ("optimal") hemodynamic values should serve as endpoints of resuscitation or simply as markers of the physiologic reserve of critically injured patients. The failure of optimization to produce improved survival in some randomized controlled trials may be associated with delays in starting the attempt to reach optimal goals. There are limited controlled data on trauma patients. METHODS: Seventy-five consecutive severely injured patients with shock resulting from bleeding and without major intracranial or spinal cord trauma were randomized to resuscitation, starting immediately after admission, to either normal values of systolic blood pressure, urine output, base deficit, hemoglobin, and cardiac index (control group, 35 patients) or optimal values (cardiac index >4.5 L/min/m2, ratio of transcutaneous oxygen tension to fractional inspired oxygen >200, oxygen delivery index >600 mL/min/m2, and oxygen consumption index >170 mL/min/m2; optimal group, 40 patients). Initial cardiac output monitoring was done noninvasively by bioimpedance and, subsequently, invasively by thermodilution. Crystalloids, colloids, blood, inotropes, and vasopressors were used by predetermined algorithms. RESULTS: Optimal values were reached intentionally by 70% of the optimal patients and spontaneously by 40% of the control patients. There was no difference in rates of death (15% optimal vs. 11% control), organ failure, sepsis, or the length of intensive care unit or hospital stay between the two groups. Patients from both groups who achieved optimal values had better outcomes than patients who did not. The death rate was 0% among patients who achieved optimal values compared with 30% among patients who did not. Age younger than 40 years was the only independent predictive factor of the ability to reach optimal values. CONCLUSIONS: Severely injured patients who can achieve optimal hemodynamic values are more likely to survive than those who cannot, regardless of the resuscitation technique. In this study, attempts at early optimization did not improve the outcome of the examined subgroup of severely injured patients.     

Use of a topical mix of lidocaine and prilocaine during split-thickness skin graft harvest improves postoperative recovery—A prospective randomized controlled trial

PurposeTo provide evidence of efficacy and postoperative benefit of topical anesthesia (TA) for harvesting split-thickness skin graft (STSG) in an Asian population.Materials and methodsPatients with well-granulating wounds with skin grafting were randomized into TA or general anesthesia (GA) groups. In the TA group, an eutectic mixture of lidocaine and prilocaine (EMLA) was applied. Perioperative heart rate, postoperative donor site pain, adverse effects, patients’ satisfaction, duration of surgery, and operation room (OR) stay duration were recorded.ResultsThirty-nine patients (19 males, 20 females; mean age 54.9 ± 17.8) were included. Twenty underwent TA and 19 underwent GA for STSG. The TA group patients had tolerable pain during skin graft harvesting (VAS, 0.85 ± 1.5). Average EMLA exposure duration was 180.3 ± 65.8 min, and the amount applied was 1.72 ± 0.43 g/10 cm². The TA group had lower donor site pain score at one hour postoperatively (1.34 ± 1.49 vs 3.08 ± 1.90, p = 0.005), lower OR stay duration (36.5 ± 6.5 min vs 65.1 ± 17.2 min, p < 0.001) and less adverse effects than the GA group.ConclusionHarvesting STSG under TA with EMLA is an effective and efficient approach for most Asian patients with less early postoperative donor site pain and fewer adverse effects.     

Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months

Introduction

For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2–3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy.

Methods

To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains “satisfaction” and “pain” of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months.

Results

Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P?=?0.004 and P?<?0.001). There were no postoperative pathological gynecological findings.

Conclusions

Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.     

Which antimuscarinic agents used in the treatment of overactive bladder increase heart rate? a prospective randomized clinical trial

International Urology and Nephrology - To compare the heart rate increase side effect of different antimuscarinic drugs used in overactive bladder (OAB). Overall 341 patients were consecutively...     

Should acute scaphoid fractures be fixed? A randomized controlled trial

BACKGROUND: With the proliferation of different fixation screws, there is an increasing trend to recommend early internal fixation of the broken scaphoid even if the fracture is not displaced. The benefits and risks of early fixation of scaphoid fractures have not been established. These were investigated in eighty-eight patients who were of working age with clearly defined minimally displaced or undisplaced bicortical fractures of the waist of the scaphoid. METHODS: Patients who provided informed consent were randomized to treatment with early internal fixation with use of a Herbert screw without a cast (forty-four patients) or to nonoperative treatment for eight weeks with immobilization in a below-the-elbow plaster cast with the thumb left free (forty-four patients). The patients were evaluated at two, eight, twelve, twenty-six, and fifty-two weeks with respect to the severity of pain; tenderness; swelling; wrist movement; grip strength; and symptoms and disability, which were assessed with the Patient Evaluation Measure. In addition, radiographs were made and assessed at each visit. RESULTS: No difference was detected between the groups with respect to age, sex, hand dominance, side of injury, mechanism of injury, or the occupation of the patients. The range of motion, score on the Patient Evaluation Measure, and grip strength were significantly better in the group managed operatively than in the group managed nonoperatively at the eight-week follow-up evaluation, which corresponded with the visit when the cast was removed in that group. Patients returned to work at five to six weeks after the injury in both groups. At twelve weeks, grip strength was better in patients who had had surgery. No significant difference was detected between the two groups with respect to any other outcome measure at any other time. Ten of the forty-four fractures treated nonoperatively had not healed radiographically at twelve weeks, and, as a consequence, the treatment was altered. Complications occurred in thirteen patients who had been managed operatively. All complications were minor, and ten were related to the scar. CONCLUSIONS: This study did not demonstrate a clear overall benefit of early fixation of acute scaphoid fractures beyond the decrease in the rate of a change in treatment because of a delayed union at twelve weeks. Early internal fixation of minimally displaced or nondisplaced fractures of the scaphoid waist, which would heal in a cast, could lead to overtreatment of a large proportion of such fractures, exposing such patients to avoidable surgical risk. Thus, we have adopted a program of so-called aggressive conservative treatment, whereby we carefully assess fracture-healing with plain radiographs, and computed tomography scans if necessary, after six to eight weeks of cast immobilization and recommend surgical fixation with or without bone-grafting at that time if a gap is identified at the fracture site. Such an approach should result in fracture union in over 95% of such patients. LEVEL OF EVIDENCE: Therapeutic Level I.     

Evaluation of pain in bilateral total knee replacement with and without tourniquet; a?prospective randomized control trial

Aim

Thigh pain following tourniquet application is a common complaint in early post operative period following total knee arthroplasty.

Method

Post operative Thigh pain was evaluated in 30 consecutive simultaneous bilateral total knee arthroplasty patients between July 2013 and January 2014. Patient thigh pain was evaluated with the VAS score. The scale was applied on first, second, third day & second and six weeks after surgery.

Result

There were statistically significant difference in VAS score in non-tourniquet group on first, second, third post operative day. We did not find statistically significant difference at Second and Six weeks post operatively.

Conclusion

This Randomized trial demonstrates that non-tourniquet use in TKA has less early postoperative pain and leads to better recovery.     

Diet or dialysis in the elderly? The DODE study: a prospective randomized multicenter trial

There are no solid data on the real advantage of an early start of dialysis, as suggested by the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we cannot distinguish between the detrimental effect on nutrition of too low a residual renal function or too long a period of low protein-diet, per se. However, it appears that a very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the start of dialysis and can slow the progression of chronic renal failure. EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate becomes higher after the start of dialysis compared to the pre-dialysis period. Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer elderly patients better survival and better quality of life than dialysis? The answer can only come from a prospective, randomized trial, in elderly patients, starting at the GFR values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids, and with dialysis.     

Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications

Background

The fundoplication of choice for the surgical treatment of gastroesophageal reflux disease (GERD) still is debated. Multichannel intraluminal impedance monitoring (MII) has not been used to compare objective data, and comparative subjective data on laparoscopic Nissen and Toupet fundoplications are scarce.

Methods

This study randomly allocated 125 patients with documented chronic GERD to either laparoscopic floppy Nissen fundoplication (LNF; n = 62) or laparoscopic Toupet fundoplication (LTF; n = 63). The Gastrointestinal Quality of Life Index (GIQLI), symptom grading, esophageal manometry, and MII data were documented preoperatively and 1 year after surgery. The pre- and postprocedure data were compared. Statistical significance was set at a p value lower than 0.01 (NCT01321294).

Results

Both procedures resulted in significantly improved GIQLI and GERD symptoms. Preoperative dysphagia improved in both groups, but the improvement reached significance only in the LTF group. The ability to belch was shown to be significantly more decreased after LNF than after LTF. Gas-bloat and “atypical” extraesophageal symptoms also were decreased after surgery (p < 0.01). However, bowel symptoms were virtually unchanged in both groups. Both procedures resulted in significantly improved lower esophageal sphincter pressures. The improvement was greater in the LNF group than in the LTF group (p < 0.01). The DeMeester score and the numbers of total, acid, proximal, upright, and recumbent reflux episodes decreased in both groups after surgery (p < 0.01). No significant difference between the procedures in terms of MII data was found. Six patients (4.8 %) had to undergo reoperation because of intrathoracic slipping of the wrap. All the patients had undergone LNF.

Conclusions

Both procedures proved to be equally effective in improving quality of life and GERD symptoms. However, the reoperation and dysphagia rates were lower and the ability to belch was higher after LTF than after LNF.