Retos, evidencia, ética y cirujanos. Lecciones aprendidas de la evolución reciente de la cirugía colorrectal / Challenges, evidence, ethics and surgeons: Lessons learned from the recent evolution of colorectal surgery

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Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body: Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions: A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

Bowel surgery as a fertility-enhancing procedure in patients with colorectal endometriosis: methodological, pathogenic and ethical issues.

Bowel surgery for colorectal endometriosis is being promoted to infertile women without severe sub-occlusive symptoms, with the objective of improving the likelihood of conception. Contrary to rectal shaving, bowel surgery involving full-thickness disk excision and segmental resection entails opening of the intestinal lumen thus increasing the risk of postoperative infectious complications. About 1 in 10 patients undergoing colorectal resection for intestinal endometriosis will experience severe sequelae, including anastomotic dehiscence, rectovaginal fistula formation, and bladder and bowel denervation. Similar to other surgical procedures aiming at enhancing fertility in women with endometriosis, bowel surgery has been introduced into clinical practice without adequate evaluation through randomized controlled trials. According to systematic literature reviews based mainly on case series, the incremental gain of adding bowel procedures to standard surgery appears uncertain in terms of pregnancy rate after both natural attempts and IVF. Considering the methodological drawbacks and the high risk of bias in the available observational studies, it is not possible to exclude the suggestion that the benefit of colorectal surgery has been overestimated. Given the risk of harms to women's health and the important ethical implications, less emphasis should be put on strict statistical significance and more emphasis should be placed on the magnitude of the effect size. In this regard, the published data may not be generalizable, as the surgeons publishing their results may not be representative of all surgeons. Until the results of adequately designed and conducted RCTs are available, colorectal surgery with the sole intent of improving the reproductive performance of infertile patients with intestinal endometriosis should be performed exclusively within research settings and by highly experienced surgeons. Women should be informed about the uncertainties regarding the harms and benefits of bowel surgery in different clinical conditions, and preoperative counselling must be conducted impartially with the objective of achieving a truly shared medical decision.

A quality of life quandary: a framework for navigating parental refusal of treatment for co-morbidities in infants with underlying medical conditions.

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents' perceptions of their child's projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider the appropriateness of parental refusal based upon an infant's projected quality of life.

[Placebo surgery: surprises and ethical questions]. / Chirurgia-placebo: sorprese e problemi etici.

Placebo has a well-known therapeutic potential and this explains why placebo-controlled trials are considered necessary for showing the efficacy (and to a lesser extent the safety) of a new drug treatment. However, there are clear examples of a potent surgical placebo-effect in several pathological fields (cardiology, osteoarthropathy, slipped disk, post-traumatic lesions, abdominal adhesions, Parkinson's disease). The efficacy of the placebo surgery would suggest the advisability of placebo-controlled studies also for some surgical treatments. This type of trials, however, raises a number of reservations and ethical questions. In particular, it is necessary to consider the possible unethical nature of placebo surgery as against the unethical nature of surgical operations lacking any evidence of "specific" efficacy (i.e. being better than placebo).