Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes
<p>Abstract</p> <p>Background</p> <p>Laparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of random...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2006-12-01
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| Series: | BMC Surgery |
| Online Access: | http://www.biomedcentral.com/1471-2482/6/17 |
| _version_ | 1818825288951267328 |
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| author | Bäckman Karin Rahmqvist Mikael Carlsson Per Ros Axel Nilsson Erik |
| author_facet | Bäckman Karin Rahmqvist Mikael Carlsson Per Ros Axel Nilsson Erik |
| author_sort | Bäckman Karin |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Laparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of randomised trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy has not been studied. The aim of this study is to analyse characteristics, procedures, and outcomes for all patients who underwent cholecystectomy without being included in such a trial.</p> <p>Methods</p> <p>Characteristics (age, sex, co-morbidity, and ASA-score), operation time, hospital stay, and mortality were compared for patients who underwent cholecystectomy outside and within a randomised controlled trial comparing mini-laparotomy and laparoscopic cholecystectomy.</p> <p>Results</p> <p>During the inclusion period 1719 patients underwent cholecystectomy. 726 patients were randomised and 724 of them completed the trial; 993 patients underwent cholecystectomy outside the trial. The non-randomised patients were older – and had more complications from gallstone disease, higher co-morbidity, and higher ASA – score when compared with trial patients. They were also more likely to undergo acute surgery and they had a longer postoperative hospital stay, with a median 3 versus 2 days (p < 0.001 for all comparisons). Standardised mortality ratio within 90 days of operation was 3.42 (mean) (95% CI 2.17 to 5.13) for non-randomised patients and 1.61 (mean) (95%CI 0.02 to 3.46) for trial patients. For non-randomised patients, operation time did not differ significantly between mini-laparotomy and open cholecystectomy in multivariate analysis. However, the operation for laparoscopic cholecystectomy lasted 20 minutes longer than open cholecystectomy. Hospital stay was significantly shorter for both mini-laparotomy and laparoscopic cholecystectomy compared to open cholecystectomy.</p> <p>Conclusion</p> <p>Non-randomised patients were older and more sick than trial patients. The assignment of healthier patients to trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy limits the external validity of conclusions reached in such trials.</p> |
| first_indexed | 2024-12-19T00:09:24Z |
| format | Article |
| id | doaj.art-aba50e4018b4453fbd5cb9b7864eee70 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-12-19T00:09:24Z |
| publishDate | 2006-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj.art-aba50e4018b4453fbd5cb9b7864eee702022-12-21T20:46:02ZengBMCBMC Surgery1471-24822006-12-01611710.1186/1471-2482-6-17Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomesBäckman KarinRahmqvist MikaelCarlsson PerRos AxelNilsson Erik<p>Abstract</p> <p>Background</p> <p>Laparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of randomised trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy has not been studied. The aim of this study is to analyse characteristics, procedures, and outcomes for all patients who underwent cholecystectomy without being included in such a trial.</p> <p>Methods</p> <p>Characteristics (age, sex, co-morbidity, and ASA-score), operation time, hospital stay, and mortality were compared for patients who underwent cholecystectomy outside and within a randomised controlled trial comparing mini-laparotomy and laparoscopic cholecystectomy.</p> <p>Results</p> <p>During the inclusion period 1719 patients underwent cholecystectomy. 726 patients were randomised and 724 of them completed the trial; 993 patients underwent cholecystectomy outside the trial. The non-randomised patients were older – and had more complications from gallstone disease, higher co-morbidity, and higher ASA – score when compared with trial patients. They were also more likely to undergo acute surgery and they had a longer postoperative hospital stay, with a median 3 versus 2 days (p < 0.001 for all comparisons). Standardised mortality ratio within 90 days of operation was 3.42 (mean) (95% CI 2.17 to 5.13) for non-randomised patients and 1.61 (mean) (95%CI 0.02 to 3.46) for trial patients. For non-randomised patients, operation time did not differ significantly between mini-laparotomy and open cholecystectomy in multivariate analysis. However, the operation for laparoscopic cholecystectomy lasted 20 minutes longer than open cholecystectomy. Hospital stay was significantly shorter for both mini-laparotomy and laparoscopic cholecystectomy compared to open cholecystectomy.</p> <p>Conclusion</p> <p>Non-randomised patients were older and more sick than trial patients. The assignment of healthier patients to trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy limits the external validity of conclusions reached in such trials.</p>http://www.biomedcentral.com/1471-2482/6/17 |
| spellingShingle | Bäckman Karin Rahmqvist Mikael Carlsson Per Ros Axel Nilsson Erik Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes BMC Surgery |
| title | Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes |
| title_full | Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes |
| title_fullStr | Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes |
| title_full_unstemmed | Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes |
| title_short | Non-randomised patients in a cholecystectomy trial: characteristics, procedures, and outcomes |
| title_sort | non randomised patients in a cholecystectomy trial characteristics procedures and outcomes |
| url | http://www.biomedcentral.com/1471-2482/6/17 |
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