Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT) : Study protocol for a randomized controlled trial

Background: Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain. The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia. Methods: The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year. Discussion: This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved. Trial registration: The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry ( NTR6835 ) registered on November 13, 2017

Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial

Abstract Background Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain. The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia. Methods The EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year. Discussion This is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved. Trial registration The study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry (NTR6835) registered on November 13, 2017

A 5-Year Evaluation of the Implementation of Triple Diagnostics for Early Detection of Severe Necrotizing Soft Tissue Disease : A Single-Center Cohort Study

BACKGROUND: The standardized approach with triple diagnostics (surgical exploration with visual inspection, microbiological and histological examination) has been proposed as the golden standard for early diagnosis of severe necrotizing soft tissue disease (SNSTD, or necrotizing fasciitis) in ambivalent cases. This study's primary aim was to evaluate the protocolized approach after implementation for diagnosing (early) SNSTD and relate this to clinical outcome. METHODS: A cohort study analyzing a 5-year period was performed. All patients undergoing surgical exploration (with triple diagnostics) for suspected SNSTD since implementation were prospectively identified. Demographics, laboratory results and clinical outcomes were collected and analyzed. RESULT: Thirty-six patients underwent surgical exploration with eight (22%) negative explorations. The overall 30-day mortality rate was 25%, with an early, SNSTD-related mortality rate of 11% (n = 3). Of these, one patient (4%) underwent primary amputation, but died during surgery. No significant differences between baseline characteristics were found between patients diagnosed with SNSTD in early/indistinctive or late/obvious stage. Patient diagnosed at an early stage had a significantly shorter ICU stay (2 vs. 6 days, p = 0.031). Mortality did not differ between groups; patients who died were all ASA IV patients. CONCLUSION: Diagnosing SNSTD using the approach with triple diagnostics resulted in a low mortality rate and only a single amputation in a pre-terminal patient in the first 5 years after implementation. All deceased patients had multiple preexisting comorbidities consisting of severe systemic diseases, such as end-stage heart failure. Early detection proved to facilitate faster recovery with shorter ICU stay

A 5-Year Evaluation of the Implementation of Triple Diagnostics for Early Detection of Severe Necrotizing Soft Tissue Disease : A Single-Center Cohort Study

BACKGROUND: The standardized approach with triple diagnostics (surgical exploration with visual inspection, microbiological and histological examination) has been proposed as the golden standard for early diagnosis of severe necrotizing soft tissue disease (SNSTD, or necrotizing fasciitis) in ambivalent cases. This study's primary aim was to evaluate the protocolized approach after implementation for diagnosing (early) SNSTD and relate this to clinical outcome. METHODS: A cohort study analyzing a 5-year period was performed. All patients undergoing surgical exploration (with triple diagnostics) for suspected SNSTD since implementation were prospectively identified. Demographics, laboratory results and clinical outcomes were collected and analyzed. RESULT: Thirty-six patients underwent surgical exploration with eight (22%) negative explorations. The overall 30-day mortality rate was 25%, with an early, SNSTD-related mortality rate of 11% (n = 3). Of these, one patient (4%) underwent primary amputation, but died during surgery. No significant differences between baseline characteristics were found between patients diagnosed with SNSTD in early/indistinctive or late/obvious stage. Patient diagnosed at an early stage had a significantly shorter ICU stay (2 vs. 6 days, p = 0.031). Mortality did not differ between groups; patients who died were all ASA IV patients. CONCLUSION: Diagnosing SNSTD using the approach with triple diagnostics resulted in a low mortality rate and only a single amputation in a pre-terminal patient in the first 5 years after implementation. All deceased patients had multiple preexisting comorbidities consisting of severe systemic diseases, such as end-stage heart failure. Early detection proved to facilitate faster recovery with shorter ICU stay

Long-term follow-up after rib fixation for flail chest and multiple rib fractures

PURPOSE: Rib fixation for flail chest has been shown to improve in-hospital outcome, but little is known about treatment for multiple rib fractures and long-term outcome is scarce. The aim of this study was to describe the safety, long-term quality of life, and implant-related irritation after rib fixation for flail chest and multiple rib fractures. METHODS: All adult patients with blunt thoracic trauma who underwent rib fixation for flail chest or multiple rib fractures between January 2010 and December 2016 in our level 1 trauma facility were retrospectively included. In-hospital characteristics and implant removal were obtained via medical records and long-term quality of life was assessed over the telephone. RESULTS: Of the 864 patients admitted with ≥ 3 rib fractures, 166 (19%) underwent rib fixation; 66 flail chest patients and 99 multiple rib fracture patients with an ISS of 24 (IQR 18-34) and 21 (IQR 16-29), respectively. Overall, the most common complication was pneumonia (n = 58, 35%). Six (9%) patients with a flail chest and three (3%) with multiple rib fractures died, only one because of injuries related to the thorax. On average at 3.9 years, follow-up was obtained from 103 patients (62%); 40 with flail chest and 63 with multiple rib fractures reported an EQ-5D index of 0.85 (IQR 0.62-1) and 0.79 (0.62-0.91), respectively. Forty-eight (48%) patients had implant-related irritation and nine (9%) had implant removal. CONCLUSIONS: We show that rib fixation is a safe procedure and that patients reported a relative good quality of life. Patients should be counseled that after rib fixation approximately half of the patients will experience implant-related irritation and about one in ten patients requires implant material removal

Severely injured patients benefit from in-house attending trauma surgeons

INTRODUCTION: There is continuous drive to optimize healthcare for the most severely injured patients. Although still under debate, a possible measure is to provide 24/7 in-house (IH) coverage by trauma surgeons. The aim of this study was to compare process-related outcomes for severely injured patients before and after transition of attendance policy from an out-of-hospital (OH) on-call attending trauma surgeon to an in-house attending trauma surgeon. METHODS: Retrospective before-and-after study using prospectively gathered data in a Level 1 Trauma Center in the Netherlands. All trauma patients with an Injury Severity Score (ISS) >24 presenting to the emergency department for trauma before (2011-2012) and after (2014-2016) introduction of IH attendings were included. Primary outcome measures were the process-related outcomes Emergency Department length of stay (ED-LOS) and time to first intervention. RESULTS: After implementation of IH trauma surgeons, ED-LOS decreased (p =  0.009). Time from the ED to the intensive care unit (ICU) for patients directly transferred to the ICU was significantly shorter with more than doubling of the percentage of patients that reached the ICU within an hour. The percentage of patients undergoing emergency surgery within 30 min nearly doubled as well, with a larger amount of patients undergoing CT imaging before emergency surgery. CONCLUSIONS: Introduction of a 24/7 in-house attending trauma surgeon led to improved process-related outcomes for the most severely injured patients. There is clear benefit of continuous presence of physicians with sufficient experience in trauma care in hospitals treating large numbers of severely injured patients

Long-term follow-up after rib fixation for flail chest and multiple rib fractures

PURPOSE: Rib fixation for flail chest has been shown to improve in-hospital outcome, but little is known about treatment for multiple rib fractures and long-term outcome is scarce. The aim of this study was to describe the safety, long-term quality of life, and implant-related irritation after rib fixation for flail chest and multiple rib fractures. METHODS: All adult patients with blunt thoracic trauma who underwent rib fixation for flail chest or multiple rib fractures between January 2010 and December 2016 in our level 1 trauma facility were retrospectively included. In-hospital characteristics and implant removal were obtained via medical records and long-term quality of life was assessed over the telephone. RESULTS: Of the 864 patients admitted with ≥ 3 rib fractures, 166 (19%) underwent rib fixation; 66 flail chest patients and 99 multiple rib fracture patients with an ISS of 24 (IQR 18-34) and 21 (IQR 16-29), respectively. Overall, the most common complication was pneumonia (n = 58, 35%). Six (9%) patients with a flail chest and three (3%) with multiple rib fractures died, only one because of injuries related to the thorax. On average at 3.9 years, follow-up was obtained from 103 patients (62%); 40 with flail chest and 63 with multiple rib fractures reported an EQ-5D index of 0.85 (IQR 0.62-1) and 0.79 (0.62-0.91), respectively. Forty-eight (48%) patients had implant-related irritation and nine (9%) had implant removal. CONCLUSIONS: We show that rib fixation is a safe procedure and that patients reported a relative good quality of life. Patients should be counseled that after rib fixation approximately half of the patients will experience implant-related irritation and about one in ten patients requires implant material removal