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- Step-Up to Surgery (Step-Up Series)
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The first period consists of standard postoperative monitoring, which entails on demand additional examinations.
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This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. 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. Registered 5 February Major complications further increase morbidity and mortality after MAS, leading to longer intensive care and hospital stay, unplanned open procedures, creation of stomas and possible increase in cancer recurrence rates and costs [ 3 — 5 ]. A delay in diagnosis of complications increases morbidity and mortality related to major complications [ 9 — 11 ], whereas early diagnosis of postoperative septic complications, before clinical deterioration, is associated with a decrease in the associated morbidity and mortality [ 12 , 13 ].
Early detection of septic complications is challenging and may clinically, serologically and in imaging techniques be hard to distinguish from the physiological and postoperative systemic inflammatory response syndrome SIRS [ 8 , 14 , 15 ]. Furthermore clinical risk assessment appears to have a low predictive value for major complications such as anastomotic leak [ 16 ].
This further stresses the need for a standardized quality control algorithm after MAS. Notably, there are currently no standard quality control tests or protocols available for use after MAS to differentiate between a normal and a complicated postoperative course. WBC does not significantly differ in patients with an uncomplicated versus complicated postoperative course. WBC is therefore not useful in a standardized quality control algorithm. CRP is well-established as a marker of infections and complications and has shown promising results [ 19 , 20 ].
CRP levels also increase as a consequence of operative trauma, and it is even suggested that the level of postoperative CRP is proportional to the length of the operation, amount of operative trauma and intra-operative complications [ 23 ]. In uneventful cases, the levels decrease after this peak [ 24 ]. Circulating CRP levels are therefore only determined by their rate of synthesis [ 26 ]. Based on these characteristics, CRP might be a promising valuable marker for grading inflammation related to postoperative complications.
Definitions for anastomotic leak vary widely in the literature [ 33 ], which limits reproducibility and excludes patients that require re-intervention for other complications. This is in line with recent literature [ 2 , 36 ]. Serum CRP is non-specific for location, thus, additional imaging is required. Computed tomography CT is the current imaging modality of choice.
In our retrospective data, CT had sensitivity of Moreover, in the study conducted by Eckmann et al. Another recent study established CT as the preferred modality in diagnosis of anastomotic leakage [ 36 ]. In , Den Dulk et al. However the search for an optimal algorithm continues. CRP and CT scanning have been shown to differentiate between an uncomplicated and a complicated postoperative course. Currently their use is only on demand. The PRECious protocol presented here is a postoperative quality control algorithm, which is aimed at early diagnosis and treatment of patients with major complications.
The aim of this study is to evaluate the role of a standardized quality control algorithm after MAS in order to early diagnose and treat major complications and achieve safe discharge criteria. The PRECious trial is a prospective, multicenter, open, stepped-wedge study. All patients who are planned to undergo elective major digestive surgery, defined as any gastro-intestinal resection with reconstruction via anastomosis or stoma, will be included. Our hypothesis is that the standardized postoperative quality control algorithm will allow for early diagnosis and treatment of complications, thereby decreasing morbidity and mortality associated with MAS.
The primary endpoint of the study consists of a combined endpoint entailing all morbidity and mortality due to major complications. Complications will be classified according to a modified Clavien-Dindo classification in two groups [ 34 , 35 ]. Group I consists of grade I and grade II complications, which are classified as minor.
The comprehensive complication index will also be calculated [ 38 ]. All mortality and morbidity after major complications will be recorded, entailing fistula; bowel obstruction or herniation; abscesses; wound dehiscence; abdominal compartment syndrome; unplanned enterostomy; enterostomy dysfunction; myocardial infarction; pulmonary embolism; respiratory insufficiency; urosepsis; cerebrovascular accident; bleeding, and anastomotic leak.
Furthermore postoperative recovery data will be collected in both groups, such as length of hospital stay and intensive care length of stay. Alongside the trial a cost-effectiveness analysis will be conducted. The test statistic used is the two-sided Mantel-Haenszel test.click here
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The significance level of the test was targeted at 0. All adult patients who are to undergo elective MAS can be included in the study. For instance, cholecystectomy will not be included because no anastomosis or stoma is performed. Written informed consent will be obligatory. Patients who undergo emergency surgery as a primary operation will be excluded to allow for appropriate informed consent. Also patients with allergy to contrast medium will be excluded. All participating surgeons have ample experience within their respective field. This is of importance because complication rates and morbidity are associated with learning curves and might therefore affect the primary outcome [ 39 ].
Patients will be informed about the study at the outpatient clinic. The patient will be included upon admission after informed consent has been obtained. Due to the nature of the study, a parallel-randomized design is not the preferred option, because this would allow for bias by crossover and automated CRP and CT enquiries by physicians in both patient groups.
A cluster design is not deemed feasible due to differences between the participating centers i.
A stepped-wedge design is deemed appropriate. Due to the large number of participating centers, little bias is expected from other changes in treatment. Changes will be monitored and corrected for if applicable. Thus, the two groups will be compared according to two periods. Patients allocated to the first period will receive standard on-demand additional examinations.
After a transition phase of one month allowing for implementation, all patients will be allocated to the intervention arm and will receive standardized postoperative monitoring of serum CRP levels on POD 3, 4 and 5. Data collection will be via an online module, which allows for inclusion and data collection. Participating surgeons will be able to log in to the secured module via the PRECious trial website. After completing the inclusion form, an immediate response with a code number and type of postoperative control protocol will be obtained. The nature of the study does not allow for blinding, because it would not be ethical to perform sham venous puncture, and the protocol will be known by the attending physician to allow CT to be arranged.
Instead of blinding, the add-on value of CRP measurements will be tested. The attending physician will have to grade the patient in the morning before CRP levels are known, grade 1 indicating a healthy patient, grade 10 a patient at acute risk of death. Data will be collected partially by means of a secured Internet module and partially by hard-copy datasheets. The secured online module is especially designed for the PRECious trial. Hard-copy datasheets, such as completed quality of life questionnaires will be sent to the VU medical center by mail, were they will be kept in a secured room.
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Data will be collected daily until discharge. One research fellow in the VU medical center will monitor the data for all included patients, and maintain regular contact with all participating centers. Due to the nature of the study the researcher cannot be blinded, hence an external monitoring committee Clinical Research Bureau, Amsterdam, Netherlands is installed and will assess data collection. All required parameters will be collected in an SPSS data file. Data analysis will be performed according to the intention-to-treat principle.
Continuous variables will be compared using the t test or Mann-Whitney U test, as appropriate. Frequencies will be compared using the Chi-square or McNemar tests, as appropriate. Direct medical costs, non-medical costs and time-cost differences will be calculated for each arm of the study. We expect admission duration to be shorter in the PRECious arm due to early diagnosis and treatment of complications. Therefore, the protocol committee deems the protocol cost-effective. On retrospective analysis of direct medical costs in patients who underwent MAS the average cost was 8.
The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The board of executives in each participating center will have to approve the final protocol version 2. Written informed consent will be obtained from all participating patients. This trial was registered at clinicaltrials. Patients in both groups will receive similar preoperative treatment. Standard anti-thrombotic prophylaxis will be administered according to the local protocol.
Furthermore, standard prophylactic antibiotics will be administered according to the local protocol.
Step-Up to Surgery (Step-Up Series)
In the first period all patients will be allocated to the control group and will receive standard postoperative monitoring, which consists of daily measurement of clinical parameters heart rate, blood pressure, temperature, pain and assessment of the patient by the attending physician. Additional examinations such as blood sampling and imaging will only be conducted on demand, for instance, if clinical parameters deviate or physical examination shows signs of complications.
The second period will be considered the intervention group. All patients will be allocated to postoperative controls according to the PRECious protocol. It is expected that two thirds of patients will undergo CT versus one third of the control group. Intravenous contrast is administered, with regard to renal function, to conduct CT. Depending on the organ undergoing surgery, oral or rectal contrast will be administered, for which the patient will have to drink oral contrast or receive rectal administration prior to CT. After the first postoperative week, CRP samples will be collected on demand, according to the consulting physician.
If a major complication is diagnosed, immediate treatment will be commenced as soon as possible and as appropriate.
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All major complications are to be confirmed in reoperation or suspicious drain fluid upon percutaneous drainage and culture. To allow for correct implementation of the protocol a transition period of month is deemed necessary before starting measurements in the intervention group.
A flow-chart depicting the design of the study is displayed in Fig. Flow chart for the stepped wedge design of the PRECious trial. Besides differences in postoperative controls, postoperative management will be similar in both groups. Early mobilization will be encouraged, starting with sitting out of bed the first day postoperatively. A dietician will monitor intake. Patients will be discharged when they pass stools, are able to drink and eat sufficiently and are comfortable with oral analgesia. Here PROMs will be collected and morbidity monitored.
Step 2 Clinical Knowledge
In an era of advancements in surgical techniques and fast-track care, both modalities aiming to decrease morbidity and mortality after major abdominal surgery, there is currently no postoperative quality control algorithm available. A quality control algorithm should aim at safe discharge and early diagnosis and treatment of complications [ 10 , 12 ]. Den Dulk et al. Information on the predictive value of dynamic changes in CRP is not available, but will be monitored, comparing the levels on POD 2 to 5. The effect of standardized measurement of CRP levels on diagnosis of postoperative complications has yet to be determined.
Aiming for a decrease in morbidity and mortality associated with major complications after major abdominal surgery a prospective, randomized study is deemed necessary.
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The scientific research committee approved the design of the PRECious-trial. The trial is not yet recruiting. Isbister WH. Anastomotic leak in colorectal surgery: a single surgeon's experience. ANZ J Surg. Value of a step-up diagnosis plan: CRP and CT-scan to diagnose and manage postoperative complications after major abdominal surgery.
Rev Esp Enferm Dig. Endocrine Surgery Chapter Breast Chapter Skin and Soft Tissue Chapter Vascular Surgery Chapter Pediatric Surgery Chapter Orthopedic Surgery Chapter Neurosurgery Chapter Urology Chapter Otolaryngology Chapter Cardiothoracic Surgery Chapter Transplantation Chapter See All Customer Reviews. Shop Textbooks. Add to Wishlist. USD Sign in to Purchase Instantly. Temporarily Out of Stock Online Please check back later for updated availability. This review book gives you exactly what you need to prepare for the surgery clerkship, accompanying shelf exams, and the USMLE Step 2!