Surgical Informed Consent Revisited: Time to Revise the Routine?
Author list: Kinga B. Skowron, Peter Angelos
All surgery carries risk. Both surgeon and patient enter into an agreement acknowledging a certain level of risk for a belief in benefit. The surgeon, with considerably more experience on the subject, proposes the operation. The patient, often stressed by a life-changing diagnosis, consents to proceed. Upon hearing about risks of surgery, many patients would rather “die trying” than do nothing . Patients commonly trust that the surgeon will achieve the best possible outcome and agree to proceed with surgery.
Every operation has a known possibility of complication, which cannot be completely prevented even in the best of hands. A complication can be defined as “any undesirable, unintended, and direct result of an operation affecting the patient, which would not have occurred had the operation gone as well as could reasonably be hoped” . Despite a careful process of informed consent, surgeons can never convey the full scope of possible complications to a patient who is considering surgery.
Every surgeon can recall a case when a patient agreed to a high-risk emergency operation, suffered a complication, and after only a few days in the intensive care unit, the patient or the family requested to withdraw treatment. The surgeon is then faced with a difficult situation. Should he or she acquiesce to this request to withdraw treatment? The scenario raises an important question: Was consent truly “informed” in such a case? Has the surgeon somehow failed, not in the technical aspects of the operation, but in the communication with the patient? In the following paragraphs, we will explore the forces which may lead to such complicated situations.
Today, patients increasingly prefer to participate in shared decision-making with their doctors. Under this pressure, the way in which we inform our patients and obtain consent for surgery must evolve. By taking time to include patient beliefs and values in this process, we may better align the expectations of our patients with our own expectations for their post-operative course. By doing this, we may prevent those painful situations when we are asked to withdraw treatment from a patient upon whom we have just operated. When the informed consent process is optimally undertaken, surgeons can be satisfied that we have done our very best for our patients.
The 2015 Bangkok Global Surgery Declaration: A Call to the Global Health Community to Promote Implementation of the World Health Assembly Resolution for Surgery and Anaesthesia Care
Author list: K. A. McQueen, Thomas Coonan, Miliard Derbew, Viliami Tangi,Stephen Bickler, Paulin Banguti,Russel Gruen
Passage of the World Health Resolution A68/15 on 22 May 2015 calls upon the world to “Strengthen Emergency and Essential Surgical Care and Anaesthesia as a part of Universal Health Coverage”.
Recent analyses presented in the 2015 publications of the Lancet Commission on Global Surgery and the 3rd Edition of the World Bank’s Disease Control Priorities in Developing Countries Essential Surgery Volume demonstrate that investments in surgical and anaesthesia care are cost-effective and fundamental to achieving Universal Health Coverage.
Building upon tenets of the Amsterdam Declaration on Essential Surgical Care ratified in November 2014 which called for the passage of WHA A68/15 and action towards its key components, the following Declaration promotes global collaboration among all countries and regions to work towards implementation solutions for ensuring “universal access to safe, affordable surgical and anaesthesia care when needed.”
An Online Tool for Global Benchmarking of Risk-Adjusted Surgical Outcomes
Author list: Richard T. Spence, David C. Chang, Kathryn Chu, Eugenio Panieri, Jessica L. Mueller, Matthew M. Hutter
Increasing evidence demonstrates significant variation in adverse outcomes following surgery between countries. In order to better quantify these variations, we hypothesize that freely available online risk calculators can be used as a tool to generate global benchmarking of risk-adjusted surgical outcomes.
This is a prospective cohort study conducted at an academic teaching hospital in South Africa (GSH). Consecutive adult patients undergoing major general or vascular surgery who met the ACS-NSQIP inclusion criteria for a 3-month period were included. Data variables required by the ACS risk calculator were prospectively collected, and patients were followed for 30 days post-surgery for the occurrence of endpoints. Calculating observed-to-expected ratios for ten outcome measures of interest generated risk-adjusted outcomes benchmarked against the ACS-NSQIP consortium.
A total of 373 major general and vascular surgery procedures met the inclusion criteria. The GSH operative cohort varied significantly compared to the 2012 ACS-NSQIP database. The risk-adjusted O/E ratios were significant for any complication O/E 1.91 (95 % CI 1.57–2.31), surgical site infections O/E 4.76 (95 % CI 3.71–6.01), renal failure O/E 3.29 (95 % CI 1.50–6.24), death O/E 3.43 (95 % CI 2.19–5.11), and total length of stay (LOS) O/E 3.43 (95 % CI 2.19–5.11).
Freely available online risk calculators can be utilized as tools for global benchmarking of risk-adjusted surgical outcomes.
Mortality Related to Appendectomy; a Population Based Analysis over Two Decades in Finland
Author list: Sannamari Kotaluoto, Mika Ukkonen, Satu-Liisa Pauniaho, Mika Helminen, Juhani Sand, Tuomo Rantanen
Appendectomy has been considered as a safe operation and negative appendectomies acceptable in order to avoid perforations. There are few publications on appendectomy-related mortality. Removal of a normal appendix has been suggested to be related to a higher mortality rate versus removal of an inflamed appendix.
Data on all appendectomy patients between 1990 and 2010 in Finland were retrieved from the Discharge Register of the National Institute for Health and Welfare and combined with data from the Death Certificate Register of Statistics Finland. Thirty-day mortality was identified and compared with overall mortality. Detailed information from death certificates of patients dying within 30-day post-surgery was collected and analyzed.
Over the study period, the thirty-day post-appendectomy mortality rate was 2.1/1000. Increased mortality was found in patients over 60 years of age. Negative appendectomy and complicated appendicitis were related to mortality. The negative appendectomy rate was higher in patients older than 40 years of age. During the study period, both mortality and the rate of negative appendectomies decreased, while the rate of laparoscopic appendectomies increased.
Post-appendectomy mortality is related to both negative appendectomies and complicated appendicitis. Diagnostic accuracy is fundamental in the care of patients with acute appendicitis, especially in the elderly. Improved diagnostic accuracy may have reduced mortality over the last two decades in Finland.
Quality of Life and Medico-Legal Implications Following Iatrogenic Bile Duct Injuries
Author list: Deepak Hariharan, Emmanouil Psaltis, John H. Scholefield, Dileep N. Lobo
In this review we aimed to evaluate quality of life after bile duct injury and the consequent medico-legal implications. A comprehensive English language literature search was performed on MEDLINE, Embase, Science Citation Index and Google™ Scholar databases for articles published between January 2000 and April 2016. The last date of search was 11 April 2016. Key search words included bile duct injury, iatrogenic, cholecystectomy, prevention, risks, outcomes, quality of life, litigation and were used in combination with the Boolean operators AND, OR and NOT. Long-term survival after bile duct injury is significantly impaired (all-cause long-term mortality approximately 21 %) along with the quality of life (especially psychological/mental state remains affected). Bile duct injury is associated with high rates of litigation. Monetary compensation varied from £2500 to £216,000 in the UK, €9826–€55,301 in the Netherlands and $628,138–$2,891,421 in the USA. Bile duct injuries have profound implications for patients, medical personnel and healthcare providers as they cause significant morbidity and mortality, high rates of litigation and raised healthcare expenditure.
A comprehensive English language literature search was performed on MEDLINE, Embase, Science Citation Index and Google™ Scholar databases for articles published between January 2000 and April 2016. The last date of search was 11 April 2016. Key search words included bile duct injury, iatrogenic, cholecystectomy, prevention, risks, outcomes, quality of life, litigation and were used in combination with the Boolean operators AND, OR and NOT. The search was supplemented using the ‘related article’ function. Bibliographies of selected articles were further searched manually for studies that were missed in the initial electronic search.
A total of 398 published articles were identified of which a large majority were case reports, along with foreign language and irrelevant articles, and these were excluded (n = 272). Abstracts were screened electronically for potentially relevant papers, leading to further exclusion of 88 articles. Studies outlining preventative management strategies, quality of life (QoL) and medico-legal implications following bile duct injury were retrieved and analysed further (n = 38).
The reported incidence of bile duct injury varies from 0.4 to 1.5 % [3, 6, 7] probably due to differences in patient selection, definition of injury and the methodology used. The causes of bile duct injury are multifactorial, as shown in Table 1 [8–10]. Overconfidence on the part of the surgeon, chronic underestimation of the risk of bile duct injury and spatial disorientation leading to ‘functional fixity’ as a cause for human error are contributing factors [11, 12].
Bile duct injury following laparoscopic cholecystectomy affects the patient adversely and impacts negatively on the surgeon as well. Reviewing lessons learnt globally from litigation involving laparoscopic cholecystectomy, bile duct injury accounted for majority of claims with significant monetary settlement in favour of the Claimant, especially when the injury was detected late. As trained surgical professionals there is a need to enhance and refine how we communicate with our patients. This would help balance expectations from the surgical outcomes we constantly seek to improve. In England it is a statutory requirement by law for all healthcare professionals to adhere to the duty of candour . Surgical care providers are duty bound to be transparent when patients are harmed after intended treatments. A formal apology with an explanation must be provided, in addition to immediate and appropriate treatment to rectify the harm caused . Furthermore, incident reporting and appropriate clinical governance proceedings as per locally agreed norms must be initiated to prevent such incidents from occurring in future . This will enable care providers and organisations develop a culture of learning, openness and help promote patient safety.
The Extent of Surgery for Papillary Thyroid Microcarcinoma: The Controversy Continues
Author list: C. R. McHenry, H. Shi
The results of the study “How Many Contralateral Carcinomas in Patients with Unilateral Papillary Thyroid Microcarcinoma are Misdiagnosed Preoperatively as Benign?” by Wu and co-authors raises some important issues . The first is that 29 % of patients with papillary microcarcinoma have disease involving both lobes of the thyroid gland. Knowing that papillary microcarcinoma is an indolent cancer, with a recurrence-free survival of 97 % for tumors ≤5 mm and 86 % for tumors >5 mm at 35 years follow-up , raises a question regarding the significance of occult microscopic disease in the opposite lobe of the thyroid gland. What we do not know for sure is what the outcome would have been in the 29 % of patients had they not had the contralateral lobe of the thyroid gland removed. The advantages of leaving the contralateral lobe of the thyroid gland are that it does not expose the patient to further operative morbidity including recurrent laryngeal injury and hypoparathyroidism and it may obviate the need for exogenous thyroid hormone.
Fusion of Information from 3D Printing and Surgical Robot: An Innovative Minimally Technique Illustrated by the Resection of a Large Celiac Trunk Aneurysm
Author list: Chady Salloum, Chetana Lim, Liliana Fuentes, Michael Osseis, Alain Luciani, Daniel Azoulay
The rapid advancement in technological innovations, such as 3D printing and robotic surgery, is a progression that few could imagine just a few years ago. The combination of these technologies namely 3D printing of patient-specific anatomy and robotic surgery is reported here to plan and perform the resection of a large aneurysm of the celiac trunk.
Robotic surgery is here to stay, and this despite its merits and weaknesses remains to be ascertained. With the surgical robot, the surgeon operates remote-controlled arms facilitating laparoscopic surgery by 3D vision, and optimal ergonomics. In fact, beyond a mechanical device, the surgical robot might be considered as an information system to be fused with other information systems. For the first time, we illustrate this type of fusion, namely fusion of information provided by the 3D printing and the surgical robot.
The Addition of Dexmedetomidine to Analgesia for Patients After Abdominal Operations: A Prospective Randomized Clinical Trial
Author list: Minhua Cheng, Jialiang Shi, Juanhong Shen, Chenyan Zhao, Fengchan Xi,Weiqin Li, Wenkui Yu
Postoperative pain and anxiety are two common factors influencing patient’s recovery. Benefits and safety in the use of sedative agents after abdominal operations to improve recovery are not well known. The present study is to evaluate the efficacy and safety of dexmedetomidine use in this population.
A prospective randomized controlled trial of 145 patients undergoing abdominal operations was conducted in the Surgical Intensive Care Unit of Jinling Hospital between October and December 2015. Thirty-two patients were excluded, and 113 were included and divided into the experimental group (59 patients) receiving dexmedetomidine and analgesics for 72 h after abdominal operations, and the control group (54 patients) receiving only analgesics. Postoperative pain, inflammatory response, recovery of gastrointestinal function, adverse events, and sedation level were analyzed.
Pain scores, assessed by Prince Henry Pain Scale (PHPS), in the experimental group were significantly lower than in the control group on the first (1.53 vs. 2.07, p ≤ 0.01), second (1.07 vs. 1.63, p ≤ 0.01), and third day (1.08 vs. 1.82, p = 0.01). Time to defecation was 0.60 days shorter in the experimental group than the control group (2.51 vs. 3.11, p = 0.01). There was no significant difference between inflammatory responses in the two groups (p > 0.05). Both groups had similar blood pressure, heart rate, prevalence of bradycardia, and hypotension requiring interventions (p > 0.05).
The addition of dexmedetomidine to analgesia after abdominal operations is safe and could enhance gastrointestinal function recovery and pain control when monitored carefully. The capacity of dexmedetomidine to attenuate inflammatory responses requires further investigation.
Transanal Tube for the Prevention of Anastomotic Leakage After Rectal Cancer Surgery: A Systematic Review and Meta-analysis
Author list: Wen-Tao Zhao, Ning-Ning Li, Jin-Yan Feng
Transanal tubes (TTs) have been used to prevent and reduce anastomotic leakage after rectal cancer surgery. The aim of this review was to investigate the efficacy and safety of the TT.
A systematic literature search was performed to identify randomized controlled trials and controlled clinical trials assessing the clinical efficacy and safety of TTs in rectal cancer surgery.
Seven trials with 1609 participants were included. The TT group had a lower anastomotic leakage rate than the non-transanal tube group [RR 0.38; 95 % confidence interval (CI) 0.25–0.58; P < 0.0001], as well as a lower reoperation rate (RR 0.31; 95 % CI 0.19–0.53; P < 0.0001) and a shorter hospital stay (mean = −2.59 days; 95 % CI −3.69 to −1.49; P < 0.0001). There were no significant differences in mortality between the two groups.
TT use in rectal cancer surgery is likely to be an effective and safe method of preventing and reducing anastomotic leakage and is associated with a decreased risk of reoperation and faster recovery.
Adverse Effects of Anastomotic Leakage on Local Recurrence and Survival After Curative Anterior Resection for Rectal Cancer: A Systematic Review and Meta-analysis
Author list: Shuanhu Wang, Jingjing Liu, Shan Wang, Hongyun Zhao, Sitang Ge, Wenbin Wang
Anastomotic leakage is a serious complication associated with anterior resection for rectal cancer, the long-term effects of which are unclear. Therefore, a systematic review and meta-analysis were conducted to evaluate the impact of anastomotic leakage on disease recurrence and survival.
We searched PubMed, Embase, and the Cochrane Library databases from their inception to January 2016. Studies evaluating the oncologic impact of anastomotic leakage were included in the meta-analysis. Outcome measures were local recurrence, overall survival, cancer-specific survival, and distant recurrence. Pooled hazard ratio (HR) with 95 % confidence interval (CI) was calculated using random effects models.
Fourteen studies containing 11,353 patients met inclusion criteria. Anastomotic leakage was associated with a greater local recurrence (HR 1.71; 95 % CI 1.22–2.38) and decreased in both overall survival (HR 1.67; 95 % CI 1.19–2.35) and cancer-specific survival (HR 1.30; 95 % CI 1.08–1.56); anastomotic leakage did not increase distant recurrence (HR 1.03; 95 % CI 0.76–1.40).
Anastomotic leakage was associated with high local recurrence and poor survival (both overall and cancer-specific), but not with distant recurrence.