Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial

Drainage after cholecystectomy remains routine despite the lack of scientific supportive data. Numerous clinical studies in the past have attempted to address this controversy but have failed to resolve the issue for different reasons. These include retrospective design, inclusion of only selected cases, and randomization before surgery. In this study 479 patients undergoing cholecystectomy were randomly allocated to a drainage group (a high-pressure suction drain in Morison's pouch for 48 hours) or a nondrainage group. Randomization was performed at the time of peritoneal closure. All patients undergoing cholecystectomy, both elective and urgent, were included and the operations were performed by all grades of surgeons. There were two deaths from cardiopulmonary causes, both in the drainage group. No patient required reoperation in either group. The incidence of both wound infections (15 vs 5; p less than 0.05) and chest infections (56 vs 19, p less than 0.02) was significantly higher in the drainage group. Three hundred fifty-six patients underwent abdominal ultrasonography 72 hours after surgery. The number of subhepatic fluid collections thus detected was significantly higher in the patients who received a drain (17 vs 6, p less than 0.05). None of these collections was clinically significant. The postoperative hospital stay was longer in the patients with drains (10.3 vs 9.1 days), but this difference failed to reach statistical significance. We conclude from this study that the use of a drain after cholecystectomy serves no useful purpose and is potentially harmful. This practice should be abandoned.     

单纯椎管减压术与椎管减压合并内固定融合术治疗退变性脊柱侧凸的前瞻性随机对照研究

[目的]采用前瞻性随机对照试验的方法比较单纯椎管减压术与椎管减压合并内固定融合术治疗退变性脊柱侧凸的短期疗效,为制定手术方案提供依据。[方法]2012年11月~2014年2月,对62例符合纳入标准的退变性脊柱侧凸患者进行前瞻性随机对照试验研究。将符合纳入标准的患者分别随机选入A组或B组,A组采用单纯椎管减压术治疗,减压方法为潜行减压。B组采用减压合并内固定融合术治疗。A组共30例(其中男6例,女24例),B组共32例(其中男8例,女24例)。记录两组患者临床及随访的数据资料,采用SPSS 17.0对数据进行统计学分析。[结果]术后随访15~24个月,平均19个月。两组术后3个月冠状面Cobb角平均值与术前比较,差异有统计学意义(P0.001);末次随访冠状面Cobb角与术后3个月比较,差异无统计学意义,两种手术末次随访与术后3个月比较Cobb角变化差异无统计学意义。A组术后Cobb角矫正率为(42±25)%;B组为(59±28)%,B组平均值高于A组,且差异有统计学意义(P0.001)。所有患者术后临床症状均逐渐缓解,两组患者术后3个月与术前比较,末次随访与术后3个月比较,ODI、VAS数值均逐渐减小,P值均0.001,差异有统计学意义。B组术中失血量、手术时间、住院天数、下床时间、并发症例数均高于A组,且差异有统计学意义。随访期间两种手术后患者的临床症状逐渐改善,Cobb角均无加重趋势。[结论]采用潜行减压的方法单纯椎管减压术和椎管减压合并内固定融合术均是治疗退变性脊柱侧凸安全有效的手术方法;但单纯椎管减压术创伤小、术中失血少、手术时间短、下床及住院时间短、并发症发生少,椎管减压合并内固定融合术有较高的Cobb角矫正率。采用潜行减压可以有效避免减压节段的不稳定,防止减压节段侧凸程度的进展;采用椎管减压合并内固定融合术可以保证充分减压,保护减压节段。     

A prospective randomized clinical trial comparing tibial baseplate fixation with or without screws in total knee arthroplasty: a radiographic evaluation

In a randomized prospective study, we compared the use of tibial screws with screwless tibial baseplate fixation in uncemented total knee arthroplasty and report the results of 154 prostheses at a mean follow-up of 5 years. Patients were mobilized within 24 hours and continued with partial weight-bearing for up to 6 weeks postoperatively. There were no significant differences in radiologic results and revision rates. Radiographic outcomes do not seem to be influenced by the use of screws in tibial baseplate fixation of this prosthesis. The prosthesis studied has a large tibial keel and 4 adjunctive pegs that seem to provide adequate stability and allow bony ingrowth to take place. Longer follow-up will determine whether in this implant design, the use of tibial screws for cementless tibial baseplate fixation can be justified.     

Postoperative wound oxygen tension with epidural or intravenous analgesia: a prospective,randomized, single-blind clinical trial

BACKGROUND: Adequate tissue oxygen tension is an essential requirement for surgical-wound healing. The authors tested the hypothesis that epidural anesthesia and analgesia increases wound tissue oxygen tension compared with intravenous morphine analgesia. METHODS: In a prospective, randomized, blind clinical study, the authors allocated patients having major abdominal surgery (n = 32) to receive combined general and epidural anesthesia with postoperative patient-controlled epidural analgesia (epidural group, n = 16), or general anesthesia alone with postoperative patient-controlled intravenous analgesia (intravenous group, n = 16). An oxygen sensor and a temperature sensor were placed subcutaneously in the wound before closure. Wound oxygen tension (P(w)O(2)) and temperature were measured continuously for 24 h. Other variables affecting wound tissue oxygenation and visual analogue scale (VAS) pain scores were also documented. RESULTS: Despite epidural patients having lower body temperatures at the end of surgery (35.7 +/- 0.3) versus 36.3 +/- 0.5 degrees C, = 0.004), they had significantly higher mean P(w)O(2) over the 24 h period, compared with the intravenous group (64.4 +/- 14 vs. 50.7 +/- 15) mmHg, mean (SD), 95% CI difference, -22 to -5, = 0.002). Area under the P(w)O(2) -24 h time curve was also significantly higher in the epidural group (930 +/- 278 vs. 749 +/- 257) mmHg x h, 95% CI difference -344 to -18, = 0.03). VAS pain scores at rest and moving were significantly lower in the epidural group at all times. CONCLUSION: Epidural anesthesia and postoperative analgesia for major abdominal surgery increases wound tissue oxygen tension compared with general anesthesia and intravenous morphine analgesia.     

The treatment of acute superficial abscesses: a prospective clinical trial.

A total of 219 acute superficial abscesses was treated. Patients were randomly allocated to one of four treatment groups--primary suture with or without antibiotics and free drainage with or without antibiotics. No difference could be detected between the groups in duration of healing time. Eleven per cent of all abscesses sutured recurred and antibiotics did not affect this rate. It is suggested that free drainage following incision and drainage is the safest treatment for the majority of abscesses. Antibiotics do not have any significant effect on healing time or recurrence and their routine use is not recommended.     

Biliary reconstruction with or without an internal biliary stent in orthotopic liver transplantation: a prospective randomised trial

Abstract Choledochocholedochostomy (CCD) with a 7 fr/8 fr Cotton Leung internal biliary stent removed at endoscopic retrograde cholangiography (ERC) 3 months following orthotopic liver transplantation (OLT) was the technique used on our unit for biliary reconstruction. From June 1995 to July 1996, we randomised 37 OLT patients with CCDs to receive either an internal stent (group I, n d = 18) or no stent (group II, n = 19). Patients in group I had an ERC at 3 months for stent removal whereas patients in group II had an ERC if indicated. The mean follow up was 19 (13–26) months. Biliary complications occurred in 9 out of 18 patients in group I compared to 1 out of 19 patients in group II ( P = 0.007). In group I, ERC was required for complications in 8 patients and early surgery in 2, compared to 1 ERC for abnormal liver function tests in group II. Five of the early complications in group I were stent related. Late biliary stenosis occurred in 1 patient at 9 months. There was one stent-related death. The use of stents contributes to biliary complications and CCD without stenting is safe after OLT.     

Radical peritoneal debridement for established peritonitis. The results of a prospective randomized clinical trial

A randomized, prospective comparison of radical peritoneal debridement and standard surgical management of peritonitis disclosed no differences in terms of hospital mortality for the frequency of reoperation for abscess. Adjunctive measures such as antibiotic therapy and peritoneal irrigation were identical between the groups. The groups were demographically and clinically similar but had a much lower incidence of intestinal obstruction than in the patients originally reported by Hudspeth.     

Aggressive treatment of severe diffuse peritonitis: a prospective study

In a prospective study of 22 patients with diffuse peritonitis managed by the method of electively staged multiple laparotomies, the abdomen was left open in 9 patients. The patients were selected on the basis of the severity of their intra-abdominal infection: only massive faecal peritonitis, postoperative peritonitis and pancreatic abscesses were included. These amounted to only 9 per cent of all patients with intra-abdominal infection treated over a 2-year period. Up to seven re-operations were required per patient. In view of a high mortality rate of 32 per cent, the superiority of this aggressive management strategy over conventional methods is not fully established.     

Single intra-articular injection with or without intra-osseous injections of platelet-rich plasma in the treatment of osteoarthritis knee: A single-blind,randomized clinical trial

BackgroundSubchondral bony structure damage plays an essential role in the pathogenesis of osteoarthritis (OA) knee. An intra-articular injection cannot reach the damaged subchondral bony structure and treat its pathologies effectively. The objective of the study was to compare the clinical effects of single intra-articular injection with or without intra-osseous injections of PRP in the treatment of osteoarthritis (OA) knee.MethodsThis was a single-blind, parallel-group, randomized clinical trial. Fifty patients, with OA knee (K&L grade III), with ages between 50 and 65 years, were randomly allocated into ‘intra-osseous, intra-articular PRP’ (‘IO+IA-PRP’) (n = 25) or ‘intra-articular PRP’ group (‘IA-PRP’) (n = 25). Patients in the ‘IO+IA-PRP’ group received 18 ml PRP injection, and the ‘IA-PRP’ group received 8 ml PRP injection. Intra-osseous injections were given at the tibial plateau (5 ml) and femoral condyle (5 ml), along with intra-articular knee injection (8 ml), under fluoroscopic guidance. Outcomes were measured using VAS-pain, the knee injury and osteoarthritis outcome score (KOOS), and the treatment satisfaction scale. All patients (n = 50) were followed up till six months.ResultsThe mean age was 57.12(4.27) years and 57.00(4.96) years in the ‘IO+IA-PRP’ and ‘IA-PRP’ groups. Both groups showed significant improvement in pain relief (VAS pain) and KOOS parameters: pain, symptoms, ADL function, sport and recreation function, and quality of life. Compared to the ‘IA-PRP’ group, the ‘IO+IA-PRP’ group showed a greater reduction of VAS pain at six months. However, no significant difference was obtained in VAS pain-relief between these two groups (p = 0.422) at six months. Similarly, at 6 months, in inter-group comparison, except ‘sport and recreation function’ (p < 0.05), no significant differences were obtained in mean-scores of KOOS parameters: pain (p = 0.514); symptom (p = 0.148), ADL-function (p = 0.991), QoL-(p = 0.376). Patients in the ‘IO+IA-PRP’ group complained of significant ‘injection-associated’ adverse events and consumed a greater number of Acetaphenomen.ConclusionsBoth groups showed significant improvement following the intervention. Intra-osseous PRP injections did not provide any additional benefit over intra-articular PRP injection until six months regarding pain relief and functional improvement.     

Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial

BACKGROUND: Pain following thoracotomy is frequently associated with clinically important abnormalities of pulmonary function. The aim of the current study was to compare the efficacy of continuous thoracic epidural analgesia (EDA) to continuous intercostal (IC) block for postoperative pain and pulmonary function in a prospective, randomized, double-blinded clinical trial. METHODS: Fifty patients undergoing lung lobectomy for malignancies were randomized into two groups (25/group). Respiratory function (forced vital capacity, forced expiratory volume per 1 s/forced vital capacity, maximum midexpiratory flow rate, peak expiratory flow rate) were evaluated preoperatively, within 4 h after the operation and on the first postoperative day. Visual analog scale (VAS: 0-10) scores were evaluated four-hourly for 20 h. RESULTS: The VAS scores were significantly lower in the EDA versus IC group at the 4th, 8th, and 12th h of observation (mean +/- SD) 5.5 +/- 2.9 vs. 7.3 +/- 2.2 P = 0.04; 4.1 +/- 2.1 vs. 5.1 +/- 2.9 P = 0.02; 3.6 +/- 1.9 vs. 5.2 +/- 2.4 P = 0.01, respectively. Respiratory function parameters deteriorated significantly in both groups (P < 0.001) with no significant difference between the groups. Only one major adverse effect was detected: one patient suffered from rib osteomyelitis after intercostal cannulation and healed following surgical repair. CONCLUSIONS: The results of the present study show that following thoracotomy in the early postoperative period continuous EDA is a better pain relieving method than continuous IC block, as indicated by the VAS scores.     

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis of the hip or knee: protocol of a prospective randomised controlled clinical trial

Background  

The increasing age of the population, especially in the western world, means that the prevalence of osteoarthritis is also increasing, with corresponding socioeconomic consequences. Although there is no curative intervention at present, in accordance with US and European guidelines, pharmacotherapeutic and non-pharmacological approaches aim at pain control and the reduction of functional restriction.     

Reaction or infection: topical chloramphenicol treatment

Chloramphenicol is a topical treatment that is used widely, especially in wounds around the eyes. In our practice there have been a number of cases of delayed hypersensitivity to chloramphenicol that has been mismanaged initially as an infective cellulitis. We hope to share some of our experience of this uncommon reaction to highlight the delayed reaction that can occur with topical application of this drug.     

Minimally displaced Colles' fractures: a prospective randomized trial of treatment with a wrist splint or a plaster cast

Sixty-six adult patients with minimally displaced distal radial fractures were randomly assigned to treatment with either a plaster cast or a lightweight removable wrist splint. Outcome assessment was by clinical and radiological evaluation and an independent physiotherapy assessment. There were significant differences between the treatments for cast satisfaction, cast problems and the functional assessment score at 6 weeks, with the removable splint scoring better in all cases.