Saha Prajnaparmita, Debbarman Sambit, Ray Debasis, Gudimetla Gowtham K, Ghosh Suryadipta
Pharmacology, Agartala Government Medical College, Agartala, IND.
General Surgery, Agartala Government Medical College, Agartala, IND.
Cureus. 2025 Jul 22;17(7):e88516. doi: 10.7759/cureus.88516. eCollection 2025 Jul.
Background Informed consent is essential in surgical care to uphold patient autonomy through clear communication of diagnosis, treatment options, and risks. This study aimed to assess the practice and quality of preoperative informed consent among patients who had undergone major abdominal surgeries at a tertiary care hospital in Northeast India. Methods This hospital-based cross-sectional observational study was conducted over two months, April and May 2025, at Agartala Government Medical College & GBP Hospital. All adult patients (≥18 years) who underwent major abdominal surgeries during the study period were recruited through consecutive sampling. Data were collected using a structured questionnaire through bedside interviews conducted between postoperative days 1 and 3. The questionnaire included items related to patient understanding of their condition, surgical procedure, anesthesia, complications, alternative options, and satisfaction with the consent process. Results A total of 200 patients participated in the study, with a mean age of 44.3 (±15.0) years; the majority were female (60.5%, 121/200), from urban areas (58.5%, 117/200), and graduates (63%, 127/200). All participants reported being informed about their diagnosis, surgical procedure, anesthesia, and surgical complications. While 86.5% (173/200) were informed about anesthesia-related complications, this varied significantly with patients' place of residence and education. Similarly, 85.0% (170/200) were informed about alternative treatment options, which was significantly associated with both place of residence and type of surgery. All patients reported being given adequate time to ask questions. Consent was obtained by consultants in 91.5% (183/200) of cases, significantly associated with address and surgery type. In all instances, consent was signed by both patient and attendant, and properly witnessed. No audio or video recording was used. Overall, 94% (188/200) of participants reported satisfaction with the informed consent process, with satisfaction levels varying significantly by place of residence and educational status. Conclusion The study reveals generally good adherence to informed consent practices for major abdominal surgeries at this tertiary care hospital in Northeast India. While the overall satisfaction with the consent process was high, there is room for improvement in ensuring consistent and comprehensive information delivery across all patient demographics.
背景 在外科护理中，知情同意至关重要，它通过清晰地传达诊断、治疗方案和风险来维护患者的自主权。本研究旨在评估印度东北部一家三级护理医院中接受过腹部大手术的患者术前知情同意的实施情况和质量。
方法 这项基于医院的横断面观察性研究于2025年4月和5月在阿加尔塔拉政府医学院及GBP医院进行了两个月。通过连续抽样招募了研究期间接受腹部大手术的所有成年患者（≥18岁）。通过在术后第1天至第3天进行床边访谈，使用结构化问卷收集数据。问卷包括与患者对自身病情、手术程序、麻醉、并发症、替代方案以及对同意过程的满意度相关的项目。
结果 共有200名患者参与了研究，平均年龄为44.3（±15.0）岁；大多数为女性（60.5%，121/200），来自城市地区（58.5%，117/200），且为毕业生（63%，127/200）。所有参与者均表示被告知其诊断、手术程序、麻醉和手术并发症。虽然86.5%（173/200）的患者被告知与麻醉相关的并发症，但这因患者的居住地点和教育程度而有显著差异。同样，85.0%（170/200）的患者被告知替代治疗方案，这与居住地点和手术类型均显著相关。所有患者均表示有足够的时间提问。91.5%（183/200）的病例由顾问获得同意，这与地址和手术类型显著相关。在所有情况下，同意书均由患者和陪同人员签署，并得到妥善见证。未使用音频或视频记录。总体而言，94%（188/200）的参与者对知情同意过程表示满意，满意度因居住地点和教育程度而有显著差异。
结论 该研究表明，在印度东北部的这家三级护理医院，腹部大手术的知情同意做法总体上依从性良好。虽然对同意过程的总体满意度较高，但在确保向所有患者群体一致且全面地提供信息方面仍有改进空间。
