The PINCH-Phone: a new screenings method for recurrent incisional hernias.

BACKGROUND: Debate persists on the optimal management of incisional hernias due to paucity of accurate recurrence rates. Reoperation rates implicate a severe underestimation of the risk of a recurrence. Therefore, long-term postoperative clinic visits allowing physical examination of the abdomen are deemed necessary. However, these are time and costs consuming. Aim of this study was to develop and evaluate a new screenings method for recurrent hernias, the 'PINCH-Phone' (Post-INCisional-Hernia repair-Phone). METHODS: The PINCH-Phone is a telephone questionnaire. In this multicenter prospective study, the PINCH-Phone was answered by patients after incisional hernia repair. Afterwards the patients were seen at the clinic and physical examination was done to detect any recurrences. RESULTS: The PINCH-Phone questions were answered by 210 patients with a median postoperative follow-up of 36 months. Fifty-six patients were seen after multiple incisional hernia repairs. In 137 patients who had replied positively to one or more questions, 28 recurrent incisional hernias were detected at physical examination. Six recurrences were noted in 73 patients who had replied negatively to all questions. The overall sensitivity and specificity of the PINCH-Phone were 82% and 38%, respectively. CONCLUSION: The PINCH-Phone appears a simple and valuable screenings method for recurrences after incisional hernia repair and, hence, is recommended for implementation.

Assessing pre- and postoperative activity levels with an accelerometer: a proof of concept study.

BACKGROUND: Postoperative recovery after abdominal surgery is measured mostly based on subjective or self-reported data. In this article we aim to evaluate whether recovery of daily physical activity levels can be measured postoperatively with the use of an accelerometer. METHODS: In this multicenter, observational pilot study, 30 patients undergoing laparoscopic abdominal surgery (hysterectomy, adnexal surgery, cholecystectomy and hernia inguinal surgery) were included. Patients were instructed to wear an Actigraph wGT3X-BT accelerometer during one week before surgery (baseline) and during the first, third and fifth week after surgery. Wear time, steps taken and physical activity intensity levels (sedentary, light, moderate and vigorous) were measured. Patients were blinded for the accelerometer outcomes. Additionally, an activity diary comprising patients' self-reported time of being recovered and a list of 18 activities, in which the dates of resumption of these 18 activities were recorded after surgery, was completed by the patient. RESULTS: Five patients were excluded from analyses because of technical problems with the accelerometer (n = 1) and protocol non-adherence (n = 4). Light, moderate, vigorous, combined moderate and vigorous intensity physical activity (MVPA), and step counts showed a clear recovery curve after surgery. Patients who underwent minor surgery reached their baseline step count and MVPA three weeks after surgery. Patients who underwent intermediate surgery had not yet reached their baseline step count during the last measuring week (five weeks after surgery). The results of the activity diaries showed a fair agreement with the accelerometer results (Cohens Kappa range: 0.273-0.391). Wearing the accelerometer was well tolerated and not regarded as being burdensome by the patients. CONCLUSIONS: The accelerometer appeared to be a feasible way to measure recovery of postoperative physical activity levels in this study and was well tolerated by the patients. The agreement with self-reported physical recovery times was fair.

The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial.

BACKGROUND: After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. METHODS: A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). DISCUSSION: the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness. TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015.

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. METHODS/DESIGN: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

A new accurate method of physical examination for differentiation of inguinal hernia types.

BACKGROUND: It is generally stated that preoperative differentiation between indirect and direct inguinal hernias by physical examination is inaccurate and irrelevant. With the expansion of the laparoscopic technique, new relevance has emerged. Laparoscopic correction of an indirect hernia is more challenging and time consuming than laparoscopic correction of a direct hernia. Preoperative knowledge concerning the type of hernia informs the laparoscopic surgeon about the required expertise and the expected operative time, and this knowledge is useful for training programs and management. The authors therefore developed a new accurate and easy method of physical examination to differentiate types of inguinal hernia. A prospective study was conducted to determine the accuracy of this new method that combines physical examination with a hand-held Doppler device (not ultrasound) to differentiate types of inguinal hernia. METHODS: This prospective diagnostics study consisted of two consecutive parts. Each part included 100 consecutive patients presenting with an inguinal hernia. The inguinal occlusion test was used to differentiate the types of inguinal hernia during physical examination in the first part of the study. A hand-held Doppler device was used for adequate localization of the epigastric vessels in addition to the occlusion test in the second part of the study. Preoperative remarks were compared with findings during laparoscopic inguinal hernia repair. The McNemar symmetry χ (2) test was used for statistical evaluation RESULTS: The first part of the study showed a preoperative accuracy of 35 % for direct inguinal hernias and 86 % for indirect inguinal hernias (p < 0.001). The second part of the study showed a preoperative accuracy of 79 % for direct inguinal hernias and 93 % for indirect inguinal hernias (p < 0.001) CONCLUSION: The inguinal occlusion test combined with the use of a handheld Doppler device is accurate in distinguishing direct and indirect inguinal hernias and provides useful management information in laparoscopic inguinal hernia repair.

The incidence and natural course of occult inguinal hernias during TAPP repair: repair is beneficial.

BACKGROUND: One of the proposed advantages of laparoscopic inguinal hernia repair is complimentary inspection of the contralateral side and possible detection of occult hernias. Incidence of occult contralateral hernias is as high as 50 %. The natural course of such occult defects is unknown and therefore operative rationale is lacking. This study was designed to analyze the incidence of occult contralateral inguinal hernias and its natural course. METHODS: A total of 1,681 patients were diagnosed preoperatively with unilateral inguinal hernia. None of these patients had complaints of the contralateral side preoperatively. All patients underwent laparoscopic inguinal hernia transabdominal preperitoneal (TAPP) repair. Operative details were analyzed retrospectively. Patients with occult contralateral defects were identified and tracked. Patients with an evident occult hernia received immediate repair. Patients with a smaller beginning or incipient hernia were followed. RESULTS: In 218 (13 %) patients, an occult hernia was found at the contralateral side during preoperative exploration. In 129 (8 %) patients, an occult true hernia was found. In 89 (5 %) patients, an occult incipient hernia was found. An incipient hernia was defined as a beginning hernia. All patients with an incipient hernia were followed. The mean follow-up was 112 (range 16-218) months. Twenty-eight (32 %) patients were lost to follow-up. In the 61 remaining patients, 13 (21 %) occult incipient hernias became symptomatic requiring repair. The mean time between primary repair and development of a symptomatic hernia on the contralateral side was 88 (range 24-210) months. CONCLUSIONS: This study shows that the incidence of occult contralateral hernias is 13 % during TAPP repair of unilateral diagnosed inguinal hernias. In 5 % of the cases, the occult hernia consisted of a beginning hernia. Eventually, one of five will become symptomatic and require repair. These outcomes support immediate repair of occult defects, no matter its size.

Repeated laparoscopic treatment of recurrent inguinal hernias after previous posterior repair.

BACKGROUND: The reported recurrence rates after laparoscopic inguinal hernia repair are 0-4 %. It is unclear which technique could best be offered to a patient with a recurrent hernia after a previous posterior repair. The purpose of this retrospective study was to determine the safety, feasibility, and reliability of a repeated laparoscopic repair (TAPP) for a recurrent hernia after a previous posterior inguinal hernia repair. METHODS: The study group contains 2,594 consecutive transabdominal inguinal hernia repairs (TAPP). Of these, 53 repairs were attempted in 51 patients for recurrent hernias after a previous posterior repair. During the follow-up period, patients were examined for recurrences and for presence of a port-site hernia. Pain was scored by the visual analogue pain scale (VAS). RESULTS: Fifty-one patients underwent a TAPP repair for a recurrent inguinal hernia after previous posterior hernia repair. Two patients presented a bilateral recurrent inguinal hernia. In two thirds of the patients, the recurrence was located caudally or medially from the previously placed mesh. Two attempted repairs had to be converted to an open technique due to severe adhesions. One intraoperative complication was encountered when the vas deferens was ligated during surgery due to adhesions of the previous placed mesh. Nine patients encountered an adverse event postoperatively, but none of them were serious events. No mesh infections were reported. The mean follow-up was 70 (range, 1-198) months. At follow-up, no recurrences were found at physical examination. Four patients developed a port-site hernia. Four patients had complaints of postoperative pain and were restricted in daily activities due to groin pain. The mean VAS score (scale 0-100), including the four patients with persistent pain, was 5.7 (range, 0-61). CONCLUSIONS: It is concluded that repeated laparoscopic hernia repair (TAPP) is a definite repair for recurrent inguinal hernias. The procedure is feasible, safe, and reliable.

Delayed intrahepatic subcapsular hematoma after laparoscopic cholecystectomy.

Intrahepatic subcapsular hematoma after laparoscopic cholecystectomy is a rare complication and is potentially life threatening. When radiologic studies confirm the presence of the hematoma, the decision to follow a conservative treatment should involve clinical monitoring. If there are signs of infection, the collection can safely be drained percutaneously. If there are signs of active bleeding, a selective embolization should be attempted first. If unsuccessful, subsequent surgical evacuation should be performed. We report the case of a patient with an intrahepatic subcapsular hematoma after laparoscopic cholecystectomy, which occurred 6 weeks after surgery, and review the literature concerning the management of these bleedings.

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial.

BACKGROUND: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. METHODS/DESIGN: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for pro-supination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR2025).