An analysis of discrepancies in consent form for laparoscopic cholecystectomy in a tertiary care hospital: “FILTER” model
DOI:
https://doi.org/10.18203/2349-2902.isj20191273Keywords:
Informed consent, Laparoscopic cholecystectomy, CBD injury, Bile leak, Therapeutic privilege, Full disclosureAbstract
Background: Informed consent is needed to be full-proof but many discrepancies arise as it is subjected to individualization for each patient depending on their IQ, personality etc. Considering all aspect, the study aims to identify the issues and seek for potential remedies through “FILTER” model.
Methods: This is a retrospective, Institution-based, observational study conducted in R.G. Kar Medical College over 3 years on 500 patients who underwent laparoscopic cholecystectomy.
Results: Most of the consents (79%) were taken by consultant surgeons and rest was by junior residents. Junior residents wrote the consent form on behalf of patients in most cases (67%). 78% of the forms were signed by the patient party, 23% by patient himself and 19% by the surgeons. 67% of the total consent forms were printed and rest were hand-written. 65% of the total consent forms were signed after the patient or the patient party was informed and rest were signed without informing them. CBD injury (72%), bleeding (55%), bile leak (46%) and post-op collection (37%) were the frequency of complications encountered by the patients not informed beforehand. As the patients were informed beforehand, the need for conversion to open operation (62%), retained stone (89%), cardio-respiratory (98% and 93% respectively) complications were common. Need for an open operation, cardio-respiratory complications were most commonly informed. Bleeding (10%), CBD injury (2%) and bile leak (12%) was less informed.
Conclusions: Proper and more standardized procedures and protocols should be followed for obtaining consent irrespective of the intervention required.
Metrics
References
National Institutes of Health Consensus Development Conference Statement on Gallstones and Laparoscopic Cholecystectomy. Am J Surg. 1993;165(4):390-8.
Dubois F, Icard P, Berthelot G, Levard H. Coelioscopic cholecystectomy. Preliminary report of 36 cases. Ann Surg. 1990;211(1):60-2.
Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, et al. Laparoscopic guided cholecystectomy. Am J Surg. 1991;161(1):36-42.
Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, et al. Reduced postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991;78(2):160-2.
Duca S, Bala O, Al-Hajjar N, Lancu C, Puia IC, Munteanu D, et al. Laparoscopic Cholecystectomy: Incidents and complications. A retrospective analysis of 9542 consecutive laparoscopic operations. HPB (Oxford). 2003;5(3):152-8.
Schol FP, Go PM, Gouma DJ. Risk factors for bile duct injury in laparoscopic cholecystectomy: analysis of 49 cases. Br J Surg. 1994;81(12):1786-8.
Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992;111(5):518-26.
Liesegang TS. The meaning and need for informed consent in research. Indian J Ophthalmol. 2007;55(1):1-3.
Bailey HH, Love RJM. Surgical Ethics and Law. In: Williams N, O’Connell PR, McCaskie AW, eds. Bailey & Love’s Short Practice of Surgery vol 1. 27th ed. CRC Press Taylor and Francis Group; 2018: 170-175.
Murty OP, Reddy KN. Medical Law and Ethics. The essentials of Forensic Medicine and Toxicology. 33rd ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd; 2014: 50-56.
Byrne MF. Management of benign biliary strictures. Gastroenterol hepatol (NY). 2008;4(10):694-7.
Komrad MS. A defense of medical paternalism: maximizing patients' autonomy. J Med Ethics. 1983;9(1):38-44.
Bailey HH, Love RJM. Human factors, patient safety and quality improvement. In: Williams N, O’Connell PR, McCaskie AW, eds. Bailey & Love’s Short Practice of Surgery vol 1. 27th ed. CRC Press Taylor and Francis Group; 2018: 176-181.
