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Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery

  • Original Article
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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Objective

This study seeks to evaluate the level of anxiety, recall, and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery.

Methods

Sixty-one patients without cognitive disorders entered a prospective study designed to assess the effect of a surgical informed consent process. The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation. The State Trait Anxiety Inventory test was used to assess state anxiety and tract anxiety. The test was repeated after the informed consent process. A disease-specific feedback questionnaire was subsequently administered to assess the actual comprehension of the provided information.

Results

A significant decrease of the state anxiety scores was documented in most patients (p < 0.001). This effect was more evident in the elderly (p = 0.021) and in those who used Internet as a previous source of information (p = 0.032). The mean correct exact answer rate on the disease-specific questionnaire was 76% (IQ range 66.7–85%). No statistically significant relationship was found between the rate of correct answers and the state anxiety scores.

Conclusions

An exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are candidates to minimally invasive esophageal and gastrointestinal surgical procedures.

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Author information

Authors and Affiliations

  1. Clinical Psychology Unit IRCCS Policlinico San Donato, School of Medicine, University of Milano, Milan, Italy

    Simonetta Betti

  2. Department of Surgery IRCCS Policlinico San Donato, School of Medicine, University of Milano, Piazza Malan 2, 20097, San Donato Milanese, Milan, Italy

    Andrea Sironi, Greta Saino & Luigi Bonavina

  3. Clinical Epidemiology and Biometry Unit IRCCS Policlinico San Donato, School of Medicine, University of Milano, Milan, Italy

    Cristian Ricci

Authors
  1. Simonetta Betti
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  2. Andrea Sironi
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  3. Greta Saino
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  4. Cristian Ricci
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  5. Luigi Bonavina
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Corresponding author

Correspondence to Luigi Bonavina.

Appendix I

Appendix I

Disease-Specific Questionnaire (Esophageal Cancer)

  1. 1.

    Is a surgical operation necessary to restore your ability to swallow and to remove your cancer? (YES–NO–DO NOT KNOW)

  2. 2.

    Are you aware that an endoscopic stent would be the only alternative to make you eating again? (YES–NO)

  3. 3.

    Is the operation performed with a few short incisions in your chest, abdomen, and/or neck? (YES–NO–DO NOT KNOW)

  4. 4.

    Do you like this minimally invasive operation as opposed to the traditional open approach? (YES–NO)

  5. 5.

    Could a long abdominal and/or chest incision become anyway necessary during the operation? (YES–NO–DO NOT KNOW)

  6. 6.

    Is the operation carried out under general anesthesia? (YES–NO–DO NOT KNOW)

  7. 7.

    Will part of your stomach and the esophagus be removed? (YES–NO–DO NOT KNOW)

  8. 8.

    Is your esophagus going to be replaced by a sort of tube made with the stomach? (YES–NO–DO NOT KNOW)

  9. 9.

    Will the operation take between 3 and 6 h? (YES–NO–DO NOT KNOW)

  10. 10.

    May blood transfusions be needed during or after the operation? (YES–NO–DO NOT KNOW)

  11. 11.

    Will you be transferred to the Intensive Care Unit (ICU) at the end of the operation? (YES–NO–DO NOT KNOW)

  12. 12.

    Will you have tubes placed through your nose abdomen and/or chest after the operation? (YES–NO–DO NOT KNOW)

  13. 13.

    Will it take at least 1 week before you can start eating again? (YES–NO–DO NOT KNOW)

  14. 14.

    Could this surgical procedure, even if correctly performed, cause serious complications or even death? (YES–NO–DO NOT KNOW)

  15. 15.

    Are you aware that the risks of this operation may be increased if you already received chemotherapy or chemoradiation therapy? (YES–NO)

  16. 16.

    Are you aware that in the event complications occur your postoperative course will be longer than expected? (YES–NO)

  17. 17.

    Do you know that your eating capacity can be markedly reduced by the operation and that you may need to eat small meals more frequently during the day? (YES–NO)

  18. 18.

    Do you know that you may need to take antisecretory drugs (as Omeprazole) to control postoperative heartburn and acid regurgitation? (YES–NO)

  19. 19.

    Have you been told that the disease can recur despite radical surgery and that you may need further treatments including chemotherapy? (YES–NO)

  20. 20.

    Did you check on Internet about your esophageal disease and the way to treat it? (YES–NO)

Please answer each question by marking a slash on YES, NO, or DO NOT KNOW when appropriate.

Thank you for your cooperation!

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Betti, S., Sironi, A., Saino, G. et al. Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery. J Gastrointest Surg 15, 922–927 (2011). https://doi.org/10.1007/s11605-011-1517-7

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  • DOI: https://doi.org/10.1007/s11605-011-1517-7

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