Fractures and other chest wall abnormalities after thoracotomy for esophageal cancer: A retrospective cohort study.

BACKGROUND: Chest pain following a thoracotomy for esophageal cancer is frequently reported but poorly understood. This study aimed to (1) determine the prevalence of thoracotomy-related thoracic fractures on postoperative imaging and (2) compare complications, long-term pain, and quality of life in patients with versus without these fractures. METHODS: This retrospective cohort study enrolled patients with esophageal cancer who underwent a thoracotomy between 2010 and 2020 with pre- and postoperative CTs (<1 and/or >6 months). Disease-free patients were invited for questionnaires on pain and quality of life. RESULTS: Of a total of 366 patients, thoracotomy-related rib fractures were seen in 144 (39%) and thoracic transverse process fractures in 4 (2%) patients. Patients with thoracic fractures more often developed complications (89% vs. 74%, p = 0.002), especially pneumonia (51% vs. 39%, p = 0.032). Questionnaires were completed by 77 after a median of 41 (P25 -P75 28-91) months. Long-term pain was frequently (63%) reported but was not associated with thoracic fractures (p = 0.637), and neither were quality of life scores. CONCLUSIONS: Thoracic fractures are prevalent in patients following a thoracotomy for esophageal cancer. These thoracic fractures were associated with an increased risk of postoperative complications, especially pneumonia, but an association with long-term pain or reduced quality of life was not confirmed.

The addition of an anti-rotation screw to the dynamic hip screw.

The aim of this study is to assess if there is a difference in outcomes between a dynamic hip screw with or without an anti-rotation screw in the treatment of hip fractures. All patients with an intracapsular hip fracture who underwent dynamic hip screw osteosynthesis between January 2010 and December 2013 in three Dutch hospitals were reviewed. Minimal follow-up was one year. The study included a total of 364 patients. 24 patients were lost to follow-up and excluded. 297 (87.4%) were in the dynamic hip screw group and 43 (12.6%) in the dynamic hip with anti-rotation screw group. Direct comparison of patient characteristics of the two groups showed significant differences in age, sex, Garden classification and Pauwels classification. Patients operated with a dynamic hip screw and anti-rotation screw are significantly younger and their fractures are significantly more dislocated and steeper. To draw conclusions about differences in outcome, a randomised clinical trial should be performed.

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.

Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial.

BACKGROUND: Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. METHODS: We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). INTERPRETATION: Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.

"The Practical Perforator Flap": the sural artery flap for lower extremity soft tissue reconstruction in wounds of war.

BACKGROUND: Sural artery perforator flaps have been described for use as both local flaps and in free tissue transfer. We present the use of this flap for compound soft tissue defects of the lower limb in civilian casualties of armed conflict in Afghanistan. METHODS/RESULTS: Detailed description of the management of blast and high-velocity projectile wounds of the lower extremity with the use of local sural perforator flaps and a review of literature. CONCLUSIONS: Sural artery perforator flaps may be harvested to cover complex lower limb defects. The use of this technique is not limited to centers with complex surgical armamentarium per se, but is feasible for surgeons with good understanding of the local anatomy.

Four weeks versus six weeks of immobilization in a cast following closed reduction for displaced distal radial fractures in adult patients: a multicentre randomized controlled trial.

Aims: There is no level I evidence dealing with the optimal period of immobilization for patients with a displaced distal radial fracture following closed reduction. A shorter period might lead to a better functional outcome due to less stiffness and pain. The aim of this study was to investigate whether this period could be safely reduced from six to four weeks. Methods: This multicentre randomized controlled trial (RCT) included adult patients with a displaced distal radial fracture, who were randomized to be treated with immobilization in a cast for four or six weeks following closed reduction. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after follow-up at one year. Secondary outcomes were the abbreviated version of the Disability of Arm, Shoulder and Hand (QuickDASH) score after one year, the functional outcome at six weeks, 12 weeks, and six months, range of motion (ROM), the level of pain after removal of the cast, and complications. Results: A total of 100 patients (15 male, 85 female) were randomized, with 49 being treated with four weeks of immobilization in a cast. A total of 93 completed follow-up. The mean PRWE score after one year was 6.9 (SD 8.3) in the four-week group compared with 11.6 (SD 14.3) in the six-week group. However, this difference of -4.7 (95% confidence interval -9.29 to 0.14) was not clinically relevant as the minimal clinically important difference of 11.5 was not reached. There was no significant difference in the ROM, radiological outcome, level of pain, or complications. Conclusion: In adult patients with a displaced and adequately reduced distal radial fracture, immobilization in a cast for four weeks is safe, and the results are similar to those after a period of immobilization of six weeks.

Biomechanical characteristics of rib fracture fixation systems.

BACKGROUND: The primary aim of this study was to determine and compare the biomechanical properties of a fractured or intact rib after implant fixation on an embalmed thorax. METHODS: Five systems were fixated on the bilateral fractured or intact (randomly allocated) 6th to 10th rib of five post-mortem embalmed human specimens. Each rib underwent a four-point bending test to determine the bending structural stiffness (Newton per m2), load to failure (Newton), failure mode, and the relative difference in bending structural stiffness and load to failure as compared to a non-fixated intact rib. FINDINGS: As compared to a non-fixated intact rib, the relative difference in stiffness of a fixated intact rib ranged from -0.14 (standard deviation [SD], 0.10) to 0.53 (SD 0.35) and for a fixated fractured rib from -0.88 (SD 0.08) to 0.17 (SD 0.50). The most common failure mode was a new fracture at the most anterior drill hole for the plate and screw systems and a new fracture within the anterior portion of the implant for the clamping systems. INTERPRETATION: The current fixation systems differ in their design, mode of action, and biomechanical properties. Differences in biomechanical properties such as stiffness and load to failure especially apply to fractured ribs. Insight in the differences between the systems might guide more specific implant selection and increase the surgeon's awareness for localizing hardware complaints or failure.

Fistula formation to the bladder and to a corpus alienum as a rare complication of diverticulitis: a case report.

BACKGROUND: Fistula formation is a known complication of diverticulitis. Treatment of a diverticular fistula depends on the comorbidity of the patient and the severity of the disease. CASE REPORT: A 59-year-old man presented to the Emergency Department with chronic lower back pain that was being treated with a neurostimulator. He presented with severe sepsis, and an abscess formation near the neurostimulator. An abdominal and pelvic computed tomography scan revealed diverticulitis complicated by fistula formation to the neurostimulator and bladder. He was successfully treated by a two-stage procedure: first, exploration and drainage of the abscess, with removal of the foreign body, followed by a sigmoid resection 1 week later. CONCLUSION: In rare but severe presentations of diverticular disease, it is very important to limit initial treatment to the most threatening disorder.

Does position of the wrist during cast immobilisation in patients with distal radius fractures affect outcome?

PURPOSE: The position of the wrist during cast immobilisation following closed reduction of distal radius fractures is disputed. A systematic review was initiated to assess if there was any relation between wrist position in the cast and outcome in adult patients with non-operatively treated distal radius fractures. METHODS: A comprehensive search was performed in the bibliographic databases Medline, Embase and Wiley/Cochrane Library from inception up to 27 November 2020. Eligible studies were: randomised controlled trials, prospective and retrospective comparative cohort studies, analysing different positions of the wrist in cast-immobilisation following closed reduction. Primary outcome of the study was functional outcome measured by range of motion. Secondary outcomes were functional outcomes measured by grip strength, patient-reported outcome, radiological outcome and complications such as secondary dislocation and pain. RESULTS: The initial search yielded 2733 studies. Five trials, with 519 patients, were included in this systematic review. Range of motion and radiological outcome was significantly better in patients who were immobilised in dorsiflexion compared to palmar flexion or neutral position, although no clinical important difference was found. There were no significant differences in patient-reported outcome, pain, grip strength or complications. Due to heterogeneity of the included studies, data were unsuitable for a meta-analysis. CONCLUSION: This systematic review showed statistically significant better results in favour of cast immobilisation in dorsiflexion, although this small difference does not seem to be relevant in patients daily activities. SYSTEMATIC REVIEW REGISTRATION NUMBER: Systematic review registration number: PROSPERO 2018 CRD42018085546.

Outcome after surgical stabilization of symptomatic rib fracture nonunion: a multicenter retrospective case series.

PURPOSE: This study aimed to determine the long-term level of pain after surgical treatment of one or more symptomatic rib fracture nonunions. Secondary aims were to evaluate the occurrence of adverse events, satisfaction, and activity resumption. The final aim was to assess the association between pain and the presence of bridging callus at the nonunified fracture. Hypothesized was that thoracic pain would diminish after surgery. METHODS: This retrospective case series included adults who underwent surgery for a symptomatic rib fracture nonunion from three hospitals. Symptomatic nonunion was defined as persistent pain associated with nonbridging callus of ≥1 rib fractures on a chest CT scan at ≥3 months after the initial injury. Patients completed questionnaires about pain, satisfaction, and activity resumption ≥3 months postoperatively. RESULTS: Thirty-six patients (26 men, 10 women), with a median age of 55 (P25-P75 49-62) years and 169 acute rib fractures were included. Nonunion occurred in 98 (58%) fractures of which 70 (71%) were treated surgically. After a median of 11 months (P25-P75 7-21), 13 (36%) patients reported severe pain, in contrast to 26 (72%) preoperatively. Patients who underwent intercostal neurectomy or neurolysis in addition to surgical stabilization less often reported pain reduction. Twenty-six (72%) had postoperative complications, for which 12 (33%) underwent additional surgery, mostly for persistent pain. The majority (n = 27; 75%) was satisfied with their functional recovery. Of patients who had paid work pre-trauma, 65% had resumed working. CONCLUSION: Most patients reported less pain and better daily functioning after surgical stabilization of symptomatic rib fracture nonunions, although causality cannot be proven with this retrospective case series. Additional intercostal nerve treatment was not associated with pain relief. Despite surgery-related complications being common, patient satisfaction was high. LEVEL OF EVIDENCE: Level V. STUDY TYPE: Therapeutic.

Surgical stabilization of rib fractures versus nonoperative treatment in patients with multiple rib fractures following cardiopulmonary resuscitation: An international, retrospective matched case-control study.

BACKGROUND: The presence of six or more rib fractures or a displaced rib fracture due to cardiopulmonary resuscitation (CPR) has been associated with longer hospital and intensive care unit (ICU) length of stay (LOS). Evidence on the effect of surgical stabilization of rib fractures (SSRF) following CPR is limited. This study aimed to evaluate outcomes after SSRF versus nonoperative management in patients with multiple rib fractures after CPR. METHODS: An international, retrospective study was performed in patients who underwent SSRF or nonoperative management for multiple rib fractures following CPR between January 1, 2012, and July 31, 2020. Patients who underwent SSRF were matched to nonoperative controls by cardiac arrest location and cause, rib fracture pattern, and age. The primary outcome was ICU LOS. RESULTS: Thirty-nine operatively treated patient were matched to 66 nonoperatively managed controls with comparable CPR-related characteristics. Patients who underwent SSRF more often had displaced rib fractures (n = 28 [72%] vs. n = 31 [47%]; p = 0.015) and a higher median number of displaced ribs (2 [P 25 -P 75 , 0-3] vs. 0 [P 25 -P 75 , 0-3]; p = 0.014). Surgical stabilization of rib fractures was performed at a median of 5 days (P 25 -P 75 , 3-8 days) after CPR. In the nonoperative group, a rib fixation specialist was consulted in 14 patients (21%). The ICU LOS was longer in the SSRF group (13 days [P 25 -P 75 , 9-23 days] vs. 9 days [P 25 -P 75 , 5-15 days]; p = 0.004). Mechanical ventilator-free days, hospital LOS, thoracic complications, and mortality were similar. CONCLUSION: Despite matching, those who underwent SSRF over nonoperative management for multiple rib fractures following CPR had more severe consequential chest wall injury and a longer ICU LOS. A benefit of SSRF on in-hospital outcomes could not be demonstrated. A low consultation rate for rib fixation in the nonoperative group indicates that the consideration to perform SSRF in this population might be associated with other nonradiographic or injury-related variables. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Chest wall injuries due to cardiopulmonary resuscitation and the effect on in-hospital outcomes in survivors of out-of-hospital cardiac arrest.

BACKGROUND: This study aimed to assess the prevalence of chest wall injuries due to cardiopulmonary resuscitation for out-of-hospital cardiac arrest (OHCA) and to compare in-hospital outcomes in patients with versus without chest wall injuries. METHODS: A retrospective cohort study of all intensive care unit (ICU)-admitted patients who underwent cardiopulmonary resuscitation for OHCA between January 1, 2007, and December 2019 was performed. The primary outcome was the occurrence of chest wall injuries, as diagnosed on chest computed tomography. Chest wall injury characteristics such as rib fracture location, type, and dislocation were collected. Secondary outcomes were in-hospital outcomes and subgroup analysis of patients with good neurological recovery to identify those who could possibly benefit from the surgical stabilization of rib fractures. RESULTS: Three hundred forty-four patients were included, of which 291 (85%) sustained chest wall injury. Patients with chest wall injury had a median of 8 fractured ribs (P25-P75, 4-10 ribs), which were most often undisplaced (on chest computed tomography) (n = 1,574 [72.1%]), simple (n = 1,948 [89.2%]), and anterior (n = 1,785 [77.6%]) rib fractures of ribs 2 to 7. Eight patients (2.3%) had a flail segment, and 136 patients (39.5%) had an anterior flail segment. Patients with chest wall injury had fewer ventilator-free days (0 days [P25-P75, 0-16 days] vs. 13 days [P25-P75, 2-22 days]; p = 0.006) and a higher mortality rate (n = 102 [54.0%] vs. n = 8 [22.2%]; p < 0.001) than those without chest wall injury. For the subgroup of patients with good neurological recovery, the presence of six or more rib fractures or a single displaced rib fracture was associated with longer hospital and ICU length of stay, respectively. CONCLUSION: Cardiopulmonary resuscitation-related chest wall injuries in survivors of OHCA and especially rib fractures are common. Patients with chest wall injury had fewer ventilator-free days and a higher mortality rate. Patients with good neurological recovery might represent a subgroup of patients who could benefit from surgical stabilization of rib fractures. LEVEL OF EVIDENCE: Therapeutic, level IV; Epidemiological, Level IV.

Treatment of perforated diverticulitis with generalized peritonitis: past, present, and future.

BACKGROUND: The supposed optimal treatment of perforated diverticulitis with generalized peritonitis has changed several times during the last century, but at present is still unclear. METHODS/RESULTS: The first cases of complicated perforated diverticulitis of the colon were reported in the beginning of the twentieth century. At that time the first therapeutic guidelines were postulated in which an initial nonresectional procedure was provided to be the safest plan of management. After many years in which resection had become standard practice, today, one century later, again (laparoscopic) nonresectional surgery is presented as a safe and promising alternative in treatment of complicated perforated diverticulitis. The question rises what had happened to close the circle? CONCLUSIONS: This paper includes a historic summary of changing patterns in surgical strategies in perforated diverticulitis complicated by generalized peritonitis.

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).

BACKGROUND: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). METHODS/DESIGN: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. DISCUSSION: The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. TRIAL REGISTRATION: Nederlands Trial Register NTR2037.

Prevention of secondary displacement and reoperation of distal metaphyseal forearm fractures in children.

BACKGROUND: Metaphyseal distal forearm fractures are common in paediatric patients and treating these fractures by reduction and cast immobilization alone is under debate, since secondary displacement is a frequent complication that often warrants re-intervention. This study was conducted to invest the incidence of secondary displacement and re-intervention for non-displaced and displaced fractures, with or without fixation. MATERIAL AND METHODS: A retrospective cohort study was conducted analysing all consecutive paediatric patients under the age of 16 with distal metaphyseal forearm fractures throughout a 2-year period. Data were recorded on radiographic characteristics, OTC/AO-classification, type of treatment, reduction technique, surgical interventions and removal of hardware and complications. RESULTS: 200 Patients with displaced metaphyseal forearm fractures were included of which 139 were primarily treated in the emergency room, the other 61 patients were primarily treated in the operating room. 83% Of the patients had a satisfactory reduction in the emergency room and 94% of these patients were treated successfully with casting alone. A total of 84 patients were treated in the operating room of whom 30% underwent reduction and K-wire fixation, and 70% underwent reduction and casting only. 47% Of the patients treated with closed reduction without K-wire fixation in the operating room suffered from secondary displacement, of which 80% needed re-intervention. CONCLUSION: Metaphyseal forearm fractures can be treated with a very high success rate by closed reduction and casting alone in the emergency room. Reduction and casting of displaced metaphyseal forearm fractures in children that needed treatment in the operating room however, resulted in unacceptable high rate of secondary displacement and commonly required re-intervention. Those patients should therefore be treated by reduction and K-wire fixation.

Dislocated distal radial fractures in adult patients: 4 weeks versus 6 weeks of cast immobilisation following reduction, a multicentre randomised controlled trial, study protocol.

INTRODUCTION: Up to 30% of patients with a dislocated distal radial fracture (DRF) treated with closed reduction and cast immobilisation suffer from long-term functional restrictions. It remains unclear, whether duration of cast immobilisation influences functional outcome. The aim of this study is to evaluate whether the functional outcome of dislocated DRFs could be improved by shortening the period of immobilisation. METHODS AND ANALYSIS: A single blinded multicentre randomised controlled trial is initiated. Four weeks of plaster cast immobilisation is compared with six week plaster cast immobilisation in adult patients with adequate reduced DRFs. Primary outcome parameters are functional outcome measured with the Patient Rated Wrist Evaluation after 1 year of follow-up (FU). Secondary outcomes are: Disability of Arm, Shoulder and Hand Score after 1 year, 36-Item Short Form Health Survey after 1 year, functional outcome earlier in FU (6 weeks, 12 weeks and 6 months), range of motion, pain level and complications: number of re-interventions, secondary dislocation, delayed and non-union. ETHICS AND DISSEMINATION: The medical ethical committee VUmc approved the study protocol (2018.004, NL62861.029.17). The expectation of this study is that a shorter duration of plaster cast immobilisation is beneficial. This risk of specific complications is low and generally similar in both treatment options. FU is standardised according to current trauma guidelines. Present literature indicates that both treatment options that are used within this study are accepted protocols for treatment of dislocated DRFs. This trial will provide Level-I evidence for the comparison of functional outcome between the two treatment options for dislocated DRFs. Results of this study are expected to be published as a prospective, multicentre, randomised controlled trial article in 2021. TRIAL REGISTRATION: The Netherlands National Trial Register: NTR 6600, ABR: NL62861.029.17. Medical Ethical Committee VUmc registration number: 2018.004.

Duration of Cast Immobilization in Distal Radial Fractures: A Systematic Review.

Objective The duration of immobilization in distal radial fractures is disputed in the current literature. There are still no long-term superior outcomes of operative treatment in comparison to nonoperative treatment. A systematic review was initiated to assess the clinical controversy on the duration of the immobilization period for nonoperatively treated distal radial fractures. Materials and Methods A comprehensive search was performed in the PubMed, Embase, and Wiley/Cochrane Library databases and a manual reference check of the identified systematic reviews and meta-analyses was executed. Eligible studies were randomized controlled trials that compared two periods of immobilization, with reported functional, patient-reported, and radiological outcomes. Two reviewers independently agreed on eligibility, and assessed methodological quality and extracted outcome data. Results The initial search yielded 3.384 studies. Twelve trials, with 1063 patients, were included in this systematic review. Grip strength and patient-reported outcome were better in patients treated by a shorter period of immobilization. There was no difference in pain, range of motion, or radiological outcome between different periods of immobilization. Owing to heterogeneity of studies, data were unsuitable for pooling. Conclusion Included studies showed that there might be a preference for a shorter period of immobilization in nonoperatively treated distal radius fractures. Therefore, shortening the period of immobilization in distal radial fractures to a maximum of three weeks should be considered. Future research should include homogeneous groups of patients to draw valid conclusions on the appropriate period of immobilization for nonoperatively treated distal radial fractures. Level of Evidence This is a Level II study. Systematic Review Registration Number PROSPERO 2018 CRD42018085524.

Early fixation versus conservative therapy of multiple, simple rib fractures (FixCon): protocol for a multicenter randomized controlled trial.

Background: Multiple rib fractures are common injuries in both the young and elderly. Rib fractures account for 10% of all trauma admissions and are seen in up to 39% of patients after thoracic trauma. With morbidity and mortality rates increasing with the number of rib fractures as well as poor quality of life at long-term follow-up, multiple rib fractures pose a serious health hazard. Operative fixation of flail chest is beneficial over nonoperative treatment regarding, among others, pneumonia and both intensive care unit (ICU) and hospital length of stay. With no high-quality evidence on the effects of multiple simple rib fracture treatment, the optimal treatment modality remains unknown. This study sets out to investigate outcome of operative fixation versus nonoperative treatment of multiple simple rib fractures. Methods: The proposed study is a multicenter randomized controlled trial. Patients will be eligible if they have three or more multiple simple rib fractures of which at least one is dislocated over one shaft width or with unbearable pain (visual analog scale (VAS) or numeric rating scale (NRS) > 6). Patients in the intervention group will be treated with open reduction and internal fixation. Pre- and postoperative care equals treatment in the control group. The control group will receive nonoperative treatment, consisting of pain management, bronchodilator inhalers, oxygen support or mechanical ventilation if needed, and pulmonary physical therapy. The primary outcome measure will be occurrence of pneumonia within 30 days after trauma. Secondary outcome measures are the need and duration of mechanical ventilation, thoracic pain and analgesics use, (recovery of) pulmonary function, hospital and ICU length of stay, thoracic injury-related and surgery-related complications and mortality, secondary interventions, quality of life, and cost-effectiveness comprising health care consumption and productivity loss. Follow-up visits will be standardized and daily during hospital admission, at 14 days and 1, 3, 6, and 12 months. Discussion: With favorable results in flail chest patients, operative treatment may also be beneficial in patients with multiple simple rib fractures. The FixCon trial will be the first study to compare clinical, functional, and economic outcome between operative fixation and nonoperative treatment for multiple simple rib fractures. Trial registration: www.trialregister.nl, NTR7248. Registered May 31, 2018.

Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.

BACKGROUND: Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial. METHODS: A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44). INTERPRETATION: In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease). FUNDING: Netherlands Organisation for Health Research and Development.

Reversal of Hartmann's procedure through the stomal side: a new even more minimal invasive technique.

BACKGROUND: Several minimal invasive, mainly laparoscopic-assisted, techniques for reversal of Hartmann's procedure (HP) have been published. The purpose of this pilot study was to assess a minimal invasive procedure through the stomal site that may compare favorably with open or laparoscopic-assisted procedures in terms of operative time, hospital stay and postoperative complications. METHODS: HP reversal through the stomal side was attempted in 13 consecutive patients. Lysis of intra-abdominal adhesions was done manually through an incision at the formal stoma side, without direct vision between thumb and index finger. The rectal stump was identified intra-abdominally using a transanal rigid club. A manually controlled stapled end-to-end colorectal anastomosis was created. RESULTS: Mean duration of operation was 81 min (range 58-109 min); mean hospital stay was 4.2 days (range 2-7 days). In two patients the procedure was converted because of strong adhesions in the lower pelvic cavity around the rectal stump that could not be lysed manually safely. No complications occurred in the patients in whom reversal was completely done through the stomal site. CONCLUSIONS: In our opinion, restoration of intestinal continuity through the stomal side after HP is a feasible operation, without need for additional incisions. In the hands of a specialist gastrointestinal surgeon this technique can be attempted in all patients, as conversion to a laparoscopic-assisted or an open procedure can be performed when necessary.