A randomised trial comparing the laryngeal mask airway Supreme™ with the laryngeal mask airway Unique™ in children

We conducted a randomised controlled trial comparing the laryngeal mask airway Supreme^? with the laryngeal mask airway Unique^? in children. Fifty children presenting for elective surgery were randomly assigned to receive either the laryngeal mask airway Supreme or laryngeal mask airway Unique. The outcomes measured were airway leak pressure, ease and time for insertion, insertion success rate, fibreoptic examination, incidence of gastric insufflation, ease of gastric tube placement through the laryngeal mask airway Supreme, quality of airway during anaesthetic maintenance and complications. Median (IQR [range]) time to successful device placement was shorter with the laryngeal mask airway Unique, 14.5 [13.5–16.3 (10.0–23.6)] s than with the laryngeal mask airway Supreme, 17.4 [14.8–19.8 (11.5–29.2)] s; p = 0.007. Median (IQR [range]) airway leak pressures for the laryngeal mask airway Supreme and laryngeal mask airway Unique were 20 [16–21 (12–22)] cmH₂O and 15 [14–18 (10–24)] cmH₂O, respectively (p = 0.001). The incidence of gastric insufflation was lower with the laryngeal mask airway Supreme (zero vs six patients), p = 0.01. In conclusion, the laryngeal mask airway Supreme performed as well as the laryngeal mask airway Unique and is a useful alternative for airway maintenance, particularly in children who require evacuation of gastric contents during anaesthesia.     

A randomised, controlled trial comparing the Airtraq™ optical laryngoscope with conventional laryngoscopy in infants and children

The Airtraq^? optical laryngoscope became available in paediatric sizes in the UK in May 2008. We conducted a randomised, controlled trial comparing the Airtraq with conventional laryngoscopy during routine anaesthesia in children. We hypothesised that the Airtraq laryngoscope would perform as well as conventional laryngoscopy. Sixty patients (20 infants and 40 children) were recruited. The mean (SD) intubation time using the Airtraq was longer than conventional laryngoscopy overall (47.3 (32.6) vs 26.3 (11.5) s; p = 0.002), though the difference was only significant for children (p = 0.003) and not for infants (p = 0.29). The Airtraq provided a better view of the larynx compared with conventional laryngoscopy (in infants (percentage of glottic opening scores 100 (95–100 [90–100]) vs 77 (50–90 [40–100]), respectively; p = 0.001; visual analogue scores for field of view 9.2 (9.2–9.5 [8.2–10.0]) vs 6.8 (5.1–8.0 [4.7–10.0]), respectively; p = 0.001). In children, the Airtraq provided a similar view of the larynx (percentage of glottic opening scores 100 (100–100 [40–100]) vs 100 (90–100 [50–100]), respectively; visual analogue scores for field of view 9.2 (8.6–10.0 [7.0–10.0]) vs 9.2 (8.6–10.0 [5.6–10.0]), respectively; both p > 0.05), compared with conventional laryngoscopy.     

A randomised controlled trial comparing the McGrath(®) videolaryngoscope with the straight blade laryngoscope when used in adult patients with potential difficult airways

Studies show that both straight blade laryngoscopy and videolaryngoscopy can improve the view of the larynx when compared with the Macintosh blade laryngoscopy. However, no study has compared these two devices. A total of 80 patients with Mallampati grade ≥ 3 were randomly assigned to either have orotracheal intubation with the McGrath^® videolaryngoscope or the Henderson straight blade. The primary outcome was laryngoscopic view. Time to intubation, number of attempts, ease of intubation and complications were also recorded. Thirty‐nine out of 40 patients had grade‐1 views in the McGrath group, compared with 29 out of 40 cases in the Henderson group (p = 0.003). There were no statistically significant differences in the secondary outcomes. Two patients suffered from minor oropharyngeal injuries in the Henderson group. Apart from offering significantly more grade‐1 laryngoscopic views, the McGrath videolaryngoscope did not improve other clinical outcomes compared with the straight blade, when used in patients with poor Mallampati scores.     

Controlling intraoperative hemorrhage during burn surgery: A prospective,randomized trial comparing NuStat® hemostatic dressing to the historic standard of care

Introduction

One of the primary intraoperative challenges during burn surgery is to adequately excise the burn while avoiding massive hemorrhage. This has become increasingly important, as we see more burn patients that are older and with more medical comorbidities. While adequate excision down to healthy tissues for deep burns is essential for skin graft to take, it also leads to active bleeding that can be a challenge to control. Good hemostasis is imperative as a hematoma is the most common cause of graft loss. Several new products have become available to help control intraoperative hemorrhage. A new hemostatic dressing, NuStat^®, is available and approved by FDA in United States.

Nasotracheal fibreoptic intubation: a randomised controlled trial comparing the GlideRite® (Parker-Flex® Tip) nasal tracheal tube with a standard pre-rotated nasal RAE™ tracheal tube

In a randomised controlled study, we compared the ease of railroading a GlideRite^® nasal tracheal tube over a fibrescope with that of a pre‐rotated RAE? nasal tracheal tube. We studied 110 anaesthetised patients with no known airway difficulties undergoing elective dental or maxillofacial surgery. Impingement was more common with the GlideRite tubes (11/55 (20%)) compared with the pre‐rotated RAE tubes (3/55 (5%); p = 0.02). The median (IQR [range]) time to intubation (GlideRite 7.6 (4.7–10.8 [3.0–46.2]) s; RAE 8.0 (6.2–10.7 [2.4–30.0]) s) and postoperative sore throat numerical ratings (GlideRite 2 (0–3 [0–10]); RAE 2 (0–5 [0–8])) were similar. A 90° anticlockwise pre‐rotation of a standard nasal RAE tube has a higher initial rate of successful railroading at first attempt and is therefore superior to a GlideRite nasotracheal tube during nasal fibreoptic intubation.     

Articular-sided rotator cuff tears: which is the best repair? A three-year prospective randomised controlled trial

Purpose

To compare two groups of patients who underwent two different arthroscopic procedures for repair of articular-sided partial-thickness rotator cuff tears (PTRCTs).

Materials this is a comparative prospective study of two methods for repair of partial cuff tears

Thirty-two patients underwent arthroscopic rotator cuff repair with a transtendon technique (group 1); 28 underwent arthroscopic full-thickness conversion and repair of the lesion (group 2). ROM measures, clinical findings, MRI features (tendon healing and re-tear), Constant–Murley and ASES scores were assessed pre- and postoperatively and compared. Patients were also asked about return to sport and level of activity.

Results

At the last appointment, patients of both the groups were significantly improved for clinical findings, ROM measures, imaging features, Constant–Murley and ASES scores than at baseline, without any significant inter-group difference. In group 1, 15 of 20 patients (75 %) who practiced recreational sport activities had returned to sport at the same level as before the onset of symptoms, without any discomfort. In group 2, 12 of 18 patients (67 %) had returned to the same level of sport activity they practiced before symptoms. At the last follow up, MRI showed rotator cuff healing in 31 patients of Group 1 and 27 patients of Group 2 (p = 0.83).

Conclusions

The two procedures are safe, effective, and comparable.     

A prospective randomized clinical trial comparing the Prolene Hernia System® and the Lichtenstein patch technique for inguinal hernia repair in long term: 2- and 5-Year results

Background

Long-term sequelae in open inguinal hernia repair with either a bilayer mesh (Prolene Hernia System [PHS]) or an onlay mesh (Lichtenstein patch) were compared.

Methods

Questionnaires, phone calls, and clinical evaluation were applied as follow-up at 2 and 5 years postoperatively.

Results

Five percent of patients in the PHS group and 14% in the Lichtenstein group (P = .022) reported sensory dysfunction of the skin in the operated groin at 5 years. Chronic postoperative pain decreased over time and was reported by 11% of all patients at 5 years. Discomfort in the operated groin was found in 25% of all patients 5 years after the operation. The cumulative recurrence rate at 5 years was .8% for the PHS and 1.7% for the Lichtenstein procedure (P = .620).

Conclusions

The 2 approaches resulted in comparable rates of recurrence and long-term chronic postoperative pain. The Lichtenstein patch caused significantly more often long-term sensory dysfunction of the skin in the operated groin.     

A two-centre blinded randomised control study comparing the Lichtenstein patch, Perfix® plug and ProLoop® plug in the repair of primary inguinal hernia

Introduction

Mesh plug is an established and effective method for repair of inguinal hernia. The ProLoop plug^® (Atrium) is a recently developed mesh plug with a novel configuration, which may offer advantages over the standard Prefix plug^® (Bard) or the Lichtenstein repair. This two-centre double-blinded randomised control trial assessed the short- and medium-term outcomes, comparing the above three methods.

Patients and methods

Consecutive patients over the age of 18 years with primary unilateral inguinal hernia were randomised to receive a Lichtenstein tension free mesh repair (LTFM), Perfix^® plug (Bard) (PF) or ProLoop^® plug (Atrium) (PL) repair. Follow-up was at 2 weeks, 6 months and 12 months. Endpoints were operative time, hospital stay, bodily pain scores, return to daily activity and complications.

Results

A total of 295 consecutive patients were recruited to the study. Ninety-three patients were randomised to receive PL plug repairs, 101 PF plug repairs and 101 LTFM repairs. There was no significant difference among the three groups in terms of age, sex or BMI. There was no significant difference among the groups in terms of operative time (PL vs PF P = 0.92; PL vs LTFM P = 0.52), hospital stay (PL vs PF P = 0.74; PL vs LTFM P = 0.44), bodily pain scores (at 12 months PL vs PF P = 0.84, PL vs LTFM P = 0.85, PF vs LTFM P = 0.16), complication rates or return to daily activity.

Conclusions

The ProLoop^® plug (Atrium) is a safe and effective method of repairing primary inguinal hernias. Its novel lightweight configuration does not increase the risk of recurrence when compared to thicker mesh plugs, and it may offer benefit in terms of long-term patient comfort. The ProLoop^® plug (Atrium) represents a new effective alternative to the established mesh repairs.     

DynaMesh® in the repair of laparoscopic ventral hernia: a prospective trial

Purpose

To investigate mesh-related complications in patients undergoing laparoscopic ventral hernia repair using DynaMesh^®.

Methods

In the period 1 January 2005 through 31 December 2010, 181 consecutive patients undergoing laparoscopic ventral hernia repair in our day surgery unit using DynaMesh^® were entered prospectively in the National Danish Hernia Database. Data concerning abdominal reoperations after hernia repair were later collected on all 181 patients from the National Danish Health Registry. Postoperative telephone interviews were conducted estimating postoperative pain and patient satisfaction.

Results

Six % (11 patients) were reoperated because of mesh-related complications. Three had small bowel obstruction and one had a colonic fistula with mesh infection, all causing bowel resection and mesh removal. Mesh-related cutaneous fistula was seen in one patient. Six patients had a symptomatic recurrence requiring reoperation. Abdominal wall hematomas were seen in two cases, while two other patients had symptomatic large seromas, of which one was drained surgically. After a median follow-up of 34 months (range 12–63) in 140 patients, 66 % were pain free (0 on the Numeric Rating Scale (NRS)). Of 26 patients with moderate to severe pain (NRS > 3) at follow-up, only 4 regretted the operation. Sixteen patients thought they had a recurrence, of these only 3 regretted the operation.

Conclusion

The use of DynaMesh^® in laparoscopic ventral hernia repair was associated with a 6 % risk of mesh-related reoperation in a high volume setting. Despite chronic pain in 19 %, after 34 months follow-up patient satisfaction was high.     

A randomized prospective trial comparing clinical outcomes 3 years after surgery by Marcy repair and Prolene Hernia System® repair for adult indirect inguinal hernia

Purpose

The use of mesh in the surgical repair of adult indirect inguinal hernias is widely recommended in Western countries, but no randomized controlled trials have so far been reported in Japan. The purpose of the present randomized prospective trial was to compare a mesh method with non-mesh method for surgical repair of primary adult indirect inguinal hernias in which the diameter of the internal inguinal ring was up to 3.0 cm (I-1 or I-2 of Japanese Hernia Society Classification).

Methods

Patients with a primary unilateral inguinal hernia and I-1 or I-2 surgical findings were randomized to undergo either Marcy repair or Prolene Hernia System^® repair. Primary endpoints were recurrence, infection, and pain, with follow-up continued for 3 years postoperatively.

Results

Ninety-one of 479 patients with an inguinal hernia during the study period did not meet the exclusion criteria, and 46 were allocated to Marcy repair and 45 were allocated to Prolene Hernia System^® repair. No recurrence was observed in either group, and no significant differences were identified between the groups in any of the primary endpoints.

Conclusion

This randomized prospective trial of I-1 and I-2 inguinal hernias suggests that Marcy repair is not inferior to PHS repair. A large-scale randomized controlled trial appears warranted to confirm whether to use mesh for Japanese adult I-1 and I-2 hernias.     

A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible™ in patients undergoing dental surgery

The Laryngeal Mask Airway Flexible^TM (LMA Flexible) has been widely utilised for dental, ophthalmology and otorhinolaryngology‐related procedures. Our study evaluates two different techniques of inserting the LMA Flexible for patients undergoing day‐case dental surgery. One hundred and eight patients were randomly assigned into two groups based on the LMA Flexible insertion technique – either laryngoscopy‐guided (n = 54) or digital manipulation (standard technique; n = 54). Patient and airway characteristics were recorded before induction of anaesthesia. The primary outcome was success rate at first insertion. Other outcomes assessed included fibreoptic assessment of laryngeal mask airway placement, haemodynamic changes, need for airway adjustment during surgery and sore throat. The success rate of insertion on the first attempt was higher for the laryngoscopy‐assisted technique compared with the standard technique (96.3% vs 81.5%, respectively, p < 0.05). Fibreoptic assessment showed that the former group had better placement of the laryngeal mask airway than the latter (59.3% vs 37% p < 0.05). There were no significant differences between the two groups for haemodynamic changes. Sore throat was more common in the group with the standard technique (35.2% vs 16.7%, p < 0.05). Our study suggests the use of the laryngoscope to guide insertion of the LMA Flexible for dental surgery is a better option compared with the standard technique of digital manipulation.     

Universal or selective screening of the neonatal hip using ultrasound? A prospective,randomised trial of 15,529 newborn infants

The aim of this study was to evaluate whether universal (all neonates) or selective (neonates belonging to the risk groups) ultrasound screening of the hips should be recommended at birth. We carried out a prospective, randomised trial between 1988 and 1992, including all newborn infants at our hospital. A total of 15 529 infants was randomised to either clinical screening and ultrasound examination of all hips or clinical screening of all hips and ultrasound examination only of those at risk. The effect of the screening was assessed by the rate of late detection of congenital or developmental hip dysplasia in the two groups. During follow-up of between six and 11 years, only one late-detected hip dysplasia was seen in the universal group, compared with five in the subjective group, representing a rate of 0.13 and 0.65 per 1,000, respectively. The difference in late detection between the two groups was not statistically significant (p = 0.22). When clinical screening is of high quality, as in our study, the effect of an additional ultrasound examination, measured as late-presenting hip dysplasia, is marginal. Under such circumstances, we consider that universal ultrasound screening is not necessary, but recommend selective ultrasound screening for neonates with abnormal or suspicious clinical findings and those with risk factors for hip dysplasia.     

Should unstable extra-articular distal radial fractures be treated with fixed-angle volar-locked plates or percutaneous Kirschner wires? A prospective randomised controlled trial

Fractures of the distal radius are commonly treated with cast immobilisation; however, those potentially unstable injuries with dorsal comminution may need operative intervention. This intervention is usually with manipulation and Kirschner wires but advances in locking-plate technology have enabled surgeons to achieve anatomical reconstruction of complex fracture patterns, even in poor-quality osteoporotic bone.To ascertain if fixed-angle volar-locked plates confer a significant benefit over manipulation and Kirschner-wire stabilisation, we prospectively randomised 56 adult patients with isolated, closed, unilateral, unstable extra-articular fractures into two treatment groups, one fixed with K-wires and the other fixed with a volar locking plate.Functional outcomes were assessed using Gartland and Werley and Disabilities of the Arm, Shoulder and Hand (DASH) scores. These were statistically better in the plate group at 3 and 6 months. Radiological assessment showed statistically better results at 6 weeks, 3 months and 6 months, post-operatively. In the plate group, there was no significant loss of fracture reduction.     

Are systemic emboli reduced in computer-assisted knee surgery?: A prospective, randomised, clinical trial

We undertook a prospective, randomised study using a non-invasive transcranial Doppler device to evaluate cranial embolisation in computer-assisted navigated total knee arthroplasty (n = 14) and compared this with a standard conventional surgical technique using intramedullary alignment guides (n = 10). All patients were selected randomly without the knowledge of the patient, anaesthetists (before the onset of the procedure) and ward staff. The operations were performed by a single surgeon at one hospital using a uniform surgical approach, instrumentation, technique and release sequence. The only variable in the two groups of patients was the use of single tracker pins of the imageless navigation system in the tibia and femur of the navigated group and intramedullary femoral and tibial alignment jigs in the non-navigated group.Acetabular Doppler signals were obtained in 14 patients in the computer-assisted group and nine (90%) in the conventional group, in whom high-intensity signals were detected in seven computer-assisted patients (50%) and in all of the non-navigated patients.In the computer-assisted group no patient had more than two detectable emboli, with a mean of 0.64 (SD 0.74). In the non-navigated group the number of emboli ranged from one to 43 and six patients had more than two detectable emboli, with a mean of 10.7 (sd 13.5). The difference between the two groups was highly significant using the Wilcoxon non-parametric test (p = 0.0003).Our findings show that computer-assisted total knee arthroplasty, when compared with conventional jig-based surgery, significantly reduces systemic emboli as detected by transcranial Doppler ultrasonography.