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  1. Article: Routine 6-Week Outpatient Radiography and Visit in Patients with Conservatively Treated Multiple Rib Fractures: Valuable or a Waste of Resources?

    Peuker, Felix / Bosch, Thomas Philip / Houwert, Roderick Marijn / Hoepelman, Ruben Joost / Niemeyer, Menco Johannes Sophius / van Baal, Mark / Minervini, Fabrizio / Beeres, Frank Johannes Paulus / van de Wall, Bryan Joost Marinus

    Journal of chest surgery

    2024  

    Abstract: Background: This study investigated the incidence and clinical consequences of abnormal radiological and clinical findings during routinely performed 6-week outpatient visits in patients treated conservatively for multiple (3 or more) rib fractures.: ... ...

    Abstract Background: This study investigated the incidence and clinical consequences of abnormal radiological and clinical findings during routinely performed 6-week outpatient visits in patients treated conservatively for multiple (3 or more) rib fractures.
    Methods: A retrospective analysis was conducted among patients with multiple rib fractures treated conservatively between 2018 and 2021 (Opvent database). The primary outcome was the incidence of abnormalities on chest X-ray (CXR) and their clinical consequences, which were categorized as requiring intervention or additional clinical/radiological examination. The secondary focus was the incidence of deviation from standard treatment in response to the findings (clinical or radiological) at the routine 6-week outpatient visit.
    Results: In total, 364 patients were included, of whom 246 had a 6-week visit with CXR. The median age was 57 years (interquartile range, 46-70 years) and the median Injury Severity Score was 17 (interquartile range, 13-22). Forty-six abnormalities (18.7%) were found on CXR. These abnormalities resulted in additional outpatient visits in 4 patients (1.5%) and in chest drain insertion in 2 (0.8%). Only 2 patients (0.8%) with an abnormality on CXR presented without symptoms. None of the 118 patients who had visits without CXR experienced problems.
    Conclusion: Routine 6-week outpatient visits for patients with conservatively treated multiple rib fractures infrequently revealed abnormalities requiring treatment modifications. It may be questioned whether the 6-week outpatient visit is even necessary. Instead, a more targeted approach could be adopted, providing follow-up to high-risk or high-demand patients only, or offering guidance on recognizing warning signs and providing aftercare through a smartphone application.
    Language English
    Publishing date 2024-04-11
    Publishing country Korea (South)
    Document type Journal Article
    ISSN 2765-1606
    ISSN 2765-1606
    DOI 10.5090/jcs.23.134
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Does plate position influence the outcome in midshaft clavicular fractures? A multicenter analysis.

    Buenter, Isabelle Ruth / Kremo, Valerie / Beeres, Frank Johannes Paulus / van Veelen, Nicole Maria / Galliker, Beat / Link, Bjoern-Christian / Babst, Reto / Pape, Hans-Christoph / van de Wall, Bryan Joost Marinus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2024  

    Abstract: Purpose: To date, it remains unclear whether superior or anterior plating is the best option for treating midshaft clavicular fractures. The aim of this study was to compare both techniques with regard to the incidence of implant removal due to implant ... ...

    Abstract Purpose: To date, it remains unclear whether superior or anterior plating is the best option for treating midshaft clavicular fractures. The aim of this study was to compare both techniques with regard to the incidence of implant removal due to implant irritation, risk of complications, time to union, and function.
    Methods: In this retrospective cohort study, all midshaft clavicular fractures treated operatively between 2017 and 2020 in two hospitals in Switzerland were analyzed. The participating hospitals differed with regard to their standard practice; one offered superior plating only, while the other predominantly employed an anterior plate. The primary outcome was the incidence of implant removal for irritation. Secondary outcomes were time to union, complications, re-interventions, and range of motion during the follow-up period of at least 6 months.
    Results: In total, 168 patients were included in the study of which 81 (48%) received anterior plating and 87 (52%) superior plating. The overall mean age was 45 years (SD 16). There was no significant difference between anterior and superior plating with regard to implant removal (58.5% versus 57.1%, p = 0.887), infection (5.7% versus 1.8%, p = 0.071), and time to union (median 48 weeks versus 52 weeks, p = 0.643). Data on range of motion were available in 71 patients. There was no significant difference in anteflexion (median 180 degrees anterior versus 180 degrees superior) and abduction (median 180 degrees anterior versus 180 degrees superior) between the two groups.
    Conclusion: This retrospective cohort study did not find sufficient evidence to recommend one implant position over the other for midshaft clavicular fractures with regard to removal due to irritation. Time to union was similar and Infections were equally rare in both groups. Notably, a considerable number of patients in both groups had their implants removed due to irritation. Larger prospective studies are needed to determine how much plate position contributes to the occurrence of irritation and whether other patient or implant-related factors might play a role. Until this is clarified, implant position should be based on surgeons preference and experience.
    Language English
    Publishing date 2024-01-17
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-023-02400-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Treatment and outcome in combined scapula and rib fractures: a retrospective study.

    Hoepelman, Ruben Joost / Beeres, Frank Joseph Paulus / van Veelen, Nicole / Houwert, Roderick Marijn / Babst, Reto / Link, Björn-Christian / van de Wall, Bryan Joost Marinus

    European journal of orthopaedic surgery & traumatology : orthopedie traumatologie

    2022  Volume 33, Issue 6, Page(s) 2337–2345

    Abstract: Purpose: The primary aim was to describe the population characteristics of patients with combined scapula and rib fractures and outcomes associated with different treatment strategies.: Methods: All adult (≥ 18 years) patients with concurrent ... ...

    Abstract Purpose: The primary aim was to describe the population characteristics of patients with combined scapula and rib fractures and outcomes associated with different treatment strategies.
    Methods: All adult (≥ 18 years) patients with concurrent ipsilateral scapula and rib fractures admitted to the study hospital between 1st January 2010 and 31st June 2021 were retrospectively reviewed.
    Results: A total of 223 patients were admitted with concurrent ipsilateral rib and scapula fractures. A total of 160 patients (72%) were treated conservatively, 63 patients (28%) operatively. Among operatively treated patients, 32 (51%) underwent rib fixation (RF) only, 24 (38%) underwent scapula fixation (SF) only, and seven patients (11%) underwent combined fixation of scapula and ribs (SRF). In general, more severely injured patients were treated with more extensive surgery. RF patients had a median hospital length of stay of 16 days, the SF patients 11 days and SRF patients 18 days. There were no significant differences in complications (pneumonia, recurrent pneumothorax and revision surgery) between groups.
    Conclusion: Injury severity resulted in different treatment modalities. As a result, different patient characteristics between treatment groups were observed, which makes direct comparison between treatment modalities impossible. All treatment modalities seem feasible; however, the additional value of both rib and scapula fixation has yet to be proven in large multicentre studies.
    MeSH term(s) Adult ; Humans ; Rib Fractures/complications ; Rib Fractures/surgery ; Retrospective Studies ; Flail Chest/etiology ; Flail Chest/surgery ; Thoracic Injuries/complications ; Fracture Fixation, Internal/adverse effects ; Fracture Fixation, Internal/methods ; Treatment Outcome ; Length of Stay
    Language English
    Publishing date 2022-11-19
    Publishing country France
    Document type Journal Article
    ZDB-ID 1231084-0
    ISSN 1432-1068 ; 1633-8065 ; 0948-4817 ; 0940-3264
    ISSN (online) 1432-1068
    ISSN 1633-8065 ; 0948-4817 ; 0940-3264
    DOI 10.1007/s00590-022-03437-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies.

    Rompen, Ingmar Florin / van de Wall, Bryan Joost Marinus / van Heijl, Mark / Bünter, Isabelle / Diwersi, Nadine / Tillmann, Franz / Migliorini, Filippo / Link, Björn-Christian / Knobe, Matthias / Babst, Reto / Beeres, Frank Joseph Paulus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2022  Volume 48, Issue 4, Page(s) 3063–3071

    Abstract: Introduction: Low profile dual plate fixation using two mini fragment plates (< 2.7 mm thickness) is a relatively new technique and alternative to single plating for treating midshaft clavicle fractures. To date, no meta-analysis has been performed ... ...

    Abstract Introduction: Low profile dual plate fixation using two mini fragment plates (< 2.7 mm thickness) is a relatively new technique and alternative to single plating for treating midshaft clavicle fractures. To date, no meta-analysis has been performed comparing these two techniques. Therefore, a systematic review and meta-analysis of observational studies and randomized clinical trials was performed comparing single plating to low profile dual plating for midshaft clavicle fractures.
    Methods: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing both treatments. Effect estimates were pooled across studies using random effects models. The primary outcome is overall complication rate and re-intervention rate. Secondary outcomes include healing, operation duration and functional scores.
    Results: Low profile dual plating has favourable outcomes regarding overall complication rate (8.1% vs. 22.5%, OR 0.3, 95% CI 0.2-0.7, I
    Conclusion: This meta-analysis shows that dual plating low profile plates for midshaft clavicle fractures is a safe procedure attaining the same union rates seen in patients treated with single plating. In addition, it seems to have a lower overall complication and re-intervention rate, mostly driven by the lower incidence of implant related complaints. Low profile dual plating, however, is a fairly new technique and should be further explored in respect to more differentiated endpoints to test whether these first findings are valid.
    Level of evidence: III.
    MeSH term(s) Bone Plates ; Clavicle/injuries ; Clavicle/surgery ; Fracture Fixation, Internal/methods ; Fractures, Bone/surgery ; Humans ; Incidence ; Treatment Outcome
    Language English
    Publishing date 2022-03-02
    Publishing country Germany
    Document type Journal Article ; Systematic Review
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-021-01845-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Improving the protocol for whole-body CT scans in trauma patients.

    Studer, Stephanie / van Veelen, Nicole Maria / van de Wall, Bryan Joost Marinus / Kuner, Valerie / Schrading, Simone / Link, Björn-Christian / Knobe, Matthias / Babst, Reto / Beeres, Frank Joseph Paulus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2022  Volume 48, Issue 4, Page(s) 3149–3156

    Abstract: Purpose: While whole-body computed tomography is an established diagnostic method for the work up of polytraumatized patients, the protocols used differ between trauma centers. This study aimed to compare scan duration and estimated radiation of two ... ...

    Abstract Purpose: While whole-body computed tomography is an established diagnostic method for the work up of polytraumatized patients, the protocols used differ between trauma centers. This study aimed to compare scan duration and estimated radiation of two protocols. Secondary aim was to assess if using the revised CT protocol reduced the number of additional images of the upper extremities.
    Methods: Two groups of consecutive trauma patients, which both received a whole-body CT, were analyzed. Patients, who received a three-phased CT during which their arms needed to be repositioned from their side to above the head, were assigned to group A. Those, who received a CT with their arms placed on a pillow ventral to the abdomen throughout the entire scan were assigned to group B. Estimated radiation dose, scan duration, number of upper limb injuries and number of additional images of the upper limbs within 24 h after initial CT were assessed.
    Results: Group A consisted of 182 patients, group B of 218. The scan duration was 3 min shorter (p < 0.001) and the estimated radiation dose lower (15.0 vs 22.9 mSv, p < 0.001) in group B. There was no difference in the number of upper limb injuries detected or the number of upper limb additional images required within 24 h.
    Conclusion: Using a whole-body CT scan protocol in which the arms remain on a pillow ventral to the torso instead of one which requires a repositioning of the arms, both scan duration and estimated radiation dose can be reduced. Despite the arms being within the scanned area in the revised protocol, the number of additional imaging of the upper extremities could not be reduced.
    MeSH term(s) Humans ; Multiple Trauma/diagnostic imaging ; Tomography, X-Ray Computed/methods ; Trauma Centers ; Whole Body Imaging/methods
    Language English
    Publishing date 2022-01-28
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-021-01862-2
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  6. Article ; Online: The value of fibular fixation in patients with stabilized distal tibia fractures.

    van Veelen, Nicole Maria / van de Wall, Bryan Joost Marinus / Bleeker, Nils Jan / Buenter, Isabelle Ruth / Link, Björn-Christian / Babst, Reto / Knobe, Matthias / Beeres, Frank Joseph Paulus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2022  Volume 48, Issue 4, Page(s) 3257–3263

    Abstract: Purpose: There is currently no consensus regarding the need for fixation of concomitant fibula fractures in patients with surgically treated distal tibia fracture. Although studies have shown it to be beneficial for fractures involving the syndesmosis, ... ...

    Abstract Purpose: There is currently no consensus regarding the need for fixation of concomitant fibula fractures in patients with surgically treated distal tibia fracture. Although studies have shown it to be beneficial for fractures involving the syndesmosis, it remains unclear for suprasyndesmotic fractures. This study evaluates what effect the fixation of such suprasyndesmotic fibula fractures had on patients who underwent fixation of distal tibia fractures.
    Methods: This retrospective cohort study included all consecutive adult patients who received surgical treatment for an extra-articular or simple intraarticular distal tibia fracture between 2012 and 2020 and had a concomitant fibula fracture proximal to the syndesmosis. Two groups were formed depending on whether the fibula was stabilized. The need for revision surgery, the occurrence of complications, fracture healing, rotational and angular malalignment were evaluated for both groups.
    Results: This study included 120 patients, of which 40 (33.3%) had operative treatment of the fibula fracture. Of those with stabilized fibula fractures, 28 (70%) were treated with a plate and 12 (30%) with a titanium elastic nail. The group of patients with surgically treated fibula fractures had significantly more angular malalignments (10% vs 1.2%, p = 0.042), while there was no difference regarding rotational malalignment or fracture healing. Further, infections of the fibular surgical site occurred in 15% of surgically treated patients leading to significantly more revision surgeries in this group (40% vs 20%, p = 0.03). All infections occurred when a plate was used.
    Conclusion: This study was unable to show any benefit from stabilizing concomitant, suprasyndesmotic fibula fractures in surgically treated distal tibia fractures. On the contrary, infection, revision surgery and angular malalignment were more frequent when the fibula was fixed. Therefore, such concomitant fibula fractures should not routinely be fixed and if stabilization is deemed necessary, the implant should be chosen carefully.
    MeSH term(s) Adult ; Ankle Fractures ; Fibula/surgery ; Fracture Fixation, Internal ; Fracture Fixation, Intramedullary ; Humans ; Retrospective Studies ; Tibia ; Tibial Fractures/surgery ; Treatment Outcome
    Language English
    Publishing date 2022-02-04
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-022-01888-0
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  7. Article ; Online: Temporary external fixation versus direct ORIF in complete displaced intra-articular radius fractures: a prospective comparative study.

    van Leeuwen, Robbert Josephus Hendrik / van de Wall, Bryan Joost Marinus / van Veleen, Nicole M / Hodel, Sandro / Link, Björn-Christian / Knobe, Matthias / Babst, Reto / Beeres, Frank Joseph Paulus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2021  Volume 48, Issue 6, Page(s) 4349–4356

    Abstract: Purpose: In complex distal radius fractures (DRF), both direct osteosynthesis (one-stage approach) and temporary external fixation as a bridge to definitive osteosynthesis (two-stage approach) are used. Studies directly comparing these two management ... ...

    Abstract Purpose: In complex distal radius fractures (DRF), both direct osteosynthesis (one-stage approach) and temporary external fixation as a bridge to definitive osteosynthesis (two-stage approach) are used. Studies directly comparing these two management options are lacking. This study aims to compare the two procedures with regard to complications, and radiological and functional outcomes.
    Material: This prospective observational study included all patients presenting with AO OTA C2 or C3 DRF (1) between January 2011 and January 2018. All patients were categorised into two groups according to received treatment: patients who underwent direct definitive osteosynthesis (Group One Stage) and patients who received an external fixator followed by definitive fixation (Group Two Stage). Primary outcome was the Patient-Rated Wrist Evaluation score (PRWE) measured at 1 year follow-up. Secondary outcomes included complications, range of motion (ROM), and radiologic parameters (ulnar variance, radial inclination and volar tilt).
    Results: A total of 187 patients were included in Group One Stage with a mean age of 55.6 years (SD 17.2), of which 67 had a C2 and 120 a C3 fracture. Group Two Stage consisted of 66 patients with a mean age of 53.7 years (SD 20.4 years), of which 6 patients having a C2 and 60 a C3 fracture. There was no significant difference in complications and median PRWE between Group One Stage (12.0, IQR 2.0-20.0) and Group Two Stage (12.2, IQR 5.5-23.4) (p = 0.189), even after correction for differences in baseline characteristics. The ROM and radiologic parameters did not show any significant differences as well.
    Conclusion: No differences were found in clinical, functional, and radiological outcome between one- and two-staged surgical techniques. It may be concluded that a two-stage approach is a viable and safe alternative.
    MeSH term(s) Humans ; Middle Aged ; Radius Fractures/diagnostic imaging ; Radius Fractures/surgery ; Fracture Fixation/methods ; External Fixators ; Prospective Studies ; Bone Plates ; Intra-Articular Fractures/diagnostic imaging ; Intra-Articular Fractures/surgery ; Fracture Fixation, Internal/methods ; Range of Motion, Articular ; Treatment Outcome
    Language English
    Publishing date 2021-02-25
    Publishing country Germany
    Document type Observational Study ; Journal Article
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-021-01611-5
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  8. Article ; Online: Open plate fixation versus nailing for humeral shaft fractures: a meta-analysis and systematic review of randomised clinical trials and observational studies.

    Beeres, Frank Joseph Paulus / van Veelen, Nicole / Houwert, Roderick Marijn / Link, Björn Christian / Heng, Marilyn / Knobe, Matthias / Groenwold, Rolf Hendrik Herman / Babst, Reto / van de Wall, Bryan Joost Marinus

    European journal of trauma and emergency surgery : official publication of the European Trauma Society

    2021  Volume 48, Issue 4, Page(s) 2667–2682

    Abstract: Purpose: This meta-analysis compares open reduction and internal fixation with a plate (ORIF) versus nailing for humeral shaft fractures with regard to union, complications, general quality of life and shoulder/elbow function.: Methods: PubMed/ ... ...

    Abstract Purpose: This meta-analysis compares open reduction and internal fixation with a plate (ORIF) versus nailing for humeral shaft fractures with regard to union, complications, general quality of life and shoulder/elbow function.
    Methods: PubMed/Medline/Embase/CENTRAL/CINAHL was searched for observational studies and randomised clinical trials (RCT). Effect estimates were pooled across studies using random effects models. Results were presented as weighted odds ratio (OR) or risk difference (RD) with corresponding 95% confidence interval (95% CI). Subgroup analysis was performed stratified for study design (RCTs and observational studies).
    Results: Eighteen observational studies (4906 patients) and ten RCT's (525 patients) were included. The pooled effect estimates of observational studies were similar to those obtained from RCT's. More patients treated with nailing required re-intervention (RD 2%; OR 2.0, 95% CI 1.0-3.8) with shoulder impingement being the most predominant indication (17%). Temporary radial nerve palsy secondary to operation occurred less frequently in the nailing group (RD 2%; OR 0.4, 95% CI 0.3-0.6). Notably, all but one of the radial nerve palsies resolved spontaneously in each groups. Nailing leads to a faster time to union (mean difference - 1.9 weeks, 95% CI - 2.9 to - 0.9), lower infection rate (RD 2%; OR 0.5, 95% CI 0.3-0.7) and shorter operation duration (mean difference - 26 min, 95% CI - 37 to - 14). No differences were found regarding non-union, general quality of life, functional shoulder scores, and total upper extremity scores.
    Conclusion: Nailing carries a lower risk of infection, postoperative radial nerve palsy, has a shorter operation duration and possibly a shorter time to union. Shoulder impingement requiring re-intervention, however, is an inherent disadvantage of nail fixation. Notably, absolute differences are small and almost all patients with radial nerve palsy recovered spontaneously. Satisfactory results can be achieved with both treatment modalities.
    MeSH term(s) Bone Nails ; Bone Plates ; Fracture Fixation, Internal/methods ; Fracture Fixation, Intramedullary/methods ; Humans ; Humeral Fractures/surgery ; Humerus ; Radial Neuropathy/etiology ; Shoulder Impingement Syndrome/etiology ; Treatment Outcome
    Language English
    Publishing date 2021-07-05
    Publishing country Germany
    Document type Journal Article ; Meta-Analysis ; Review ; Systematic Review
    ZDB-ID 2275480-5
    ISSN 1863-9941 ; 1863-9933
    ISSN (online) 1863-9941
    ISSN 1863-9933
    DOI 10.1007/s00068-021-01728-7
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  9. Article ; Online: Conventional and laparoscopic reversal of the Hartmann procedure: a review of literature.

    van de Wall, Bryan Joost Marinus / Draaisma, Werner A / Schouten, Esther S / Broeders, Ivo A M J / Consten, Esther C J

    Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract

    2009  Volume 14, Issue 4, Page(s) 743–752

    Abstract: Purpose: The aim of this study was to provide a systematic overview on both laparoscopic and conventional Hartmann reversal. Furthermore, the Hartmann procedure is reevaluated in the light of new emerging alternatives.: Methods: Medline, Ovid, EMBASE, ...

    Abstract Purpose: The aim of this study was to provide a systematic overview on both laparoscopic and conventional Hartmann reversal. Furthermore, the Hartmann procedure is reevaluated in the light of new emerging alternatives.
    Methods: Medline, Ovid, EMBASE, and Cochrane database were searched for studies reporting on outcomes after Hartmann reversal.
    Results: Thirty-five studies were included in this review of which 30 were retrospective. A total of 6,249 patients with a mean age of 60 years underwent Hartmann reversal. Two thirds of patients were classified as American Society of Anesthesiologists (ASA) I-II. The mean reversal rate after a Hartmann procedure was 44%, and mean time interval between Hartmann procedure and Hartmann reversal was 7.5 months. The most frequent reported reasons for renouncing Hartmann reversal were high ASA classification and patients' refusal. The overall morbidity rate ranged from 3% to 50% (mean 16.3%) and mortality rate from 0% to 7.1% (mean 1%). Patients treated laparoscopically had a shorter hospital stay (6.9 vs. 10.7 days) and appeared to have lower mean morbidity rates compared to conventional surgery (12.2% vs. 20.3%).
    Conclusion: Hartmann reversal carries a high risk on perioperative morbidity and mortality. The mean reversal rate is considerably low (44%). Laparoscopic reversal compares favorably to conventional; however, high level evidence is needed to determine whether it is superior.
    MeSH term(s) Colorectal Neoplasms/surgery ; Colorectal Surgery/methods ; Colostomy ; Humans ; Intraoperative Complications ; Laparoscopy ; Postoperative Complications ; Reoperation
    Language English
    Publishing date 2009-11-21
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2012365-6
    ISSN 1873-4626 ; 1934-3213 ; 1091-255X
    ISSN (online) 1873-4626 ; 1934-3213
    ISSN 1091-255X
    DOI 10.1007/s11605-009-1084-3
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  10. Article ; Online: DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial.

    van de Wall, Bryan J M / Draaisma, Werner A / Consten, Esther C J / van der Graaf, Yolanda / Otten, Marten H / de Wit, G Ardine / van Stel, Henk F / Gerhards, Michael F / Wiezer, Marinus J / Cense, Huib A / Stockmann, Hein B A C / Leijtens, Jeroen W A / Zimmerman, David D E / Belgers, Eric / van Wagensveld, Bart A / Sonneveld, Eric D J A / Prins, Hubert A / Coene, Peter P L O / Karsten, Tom M /
    Klaase, Joost M / Statius Muller, Markwin G / Crolla, Rogier M P H / Broeders, Ivo A M J

    BMC surgery

    2010  Volume 10, Page(s) 25

    Abstract: Background: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by ... ...

    Abstract Background: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.
    Methods/design: The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years.
    Discussion: Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation.
    Trial registration: (Trial register number: NTR1478).
    MeSH term(s) Adolescent ; Adult ; Aged ; Diverticulitis, Colonic/surgery ; Diverticulitis, Colonic/therapy ; Elective Surgical Procedures ; Female ; Humans ; Male ; Middle Aged ; Quality of Life ; Recurrence ; Treatment Outcome ; Watchful Waiting ; Young Adult
    Language English
    Publishing date 2010-08-06
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2050442-1
    ISSN 1471-2482 ; 1471-2482
    ISSN (online) 1471-2482
    ISSN 1471-2482
    DOI 10.1186/1471-2482-10-25
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