OBJECTIVES: The decision to perform cholecystectomy in case of gallstones is based on a trade-off between the costs and risks of treatment related complications at the one hand and the mortality and morbidity associated with gallstones on the other hand. An adequate instrument for treatment planning, outcome monitoring, and clinical trials of patients with gallstone-related symptoms is therefore crucial. The Gastrointestinal Quality of Life Index (GIQLI) questionnaire has previously been validated for various gastrointestinal disorders. The purpose of the present study was to validate the Swedish translation of GIQLI specifically for gallstone disease. METHODS: GIQLI was translated to Swedish and re-translated back to German for linguistic control. Responsiveness was tested in 187 consecutive patients who underwent planned cholecystectomy. Internal consistency and test-retest stability 12 and 15 months after surgery was tested on the same sample. Construct validity was assessed by comparing the GIQLI score with the bodily pain scale of SF-36 and four single-item questions regarding pain frequency, pain localisation, the patient's own conviction of the origin of pain, and a VAS-scale in x consecutive patients. RESULTS: No major deviation was found between the original questionnaire and the re-translated version. A high responsiveness was seen, with GIQLI score increasing from 95.1 (SD 24.8) to 111.8 (SD 20.1) six months after surgery (p<0.001). The GIQLI score correlated significantly with all other measures of gallstone-related symptoms except a question regarding the patient's own conviction of the origin of the symptoms. There was a high test-retest stability, with significant correlations between the ratings 12 and 15 months for all items except one. Cronbach's alpha was found to be 0.91. CONCLUSION: The Swedish translation of GIQLI has a high validity and reliability for assessing gallstone-related symptoms.