BACKGROUND: Although the issue of drain use in open cholecystectomy has been adequately addressed by prospective randomized trials, there is lack of evidence on the usefulness of drains in elective laparoscopic cholecystectomy, and the surgeons follow their beliefs and bias on this debate. Therefore, a controlled randomized trial was designed to assess the value of drains in elective laparoscopic cholecystectomy. METHODS: During a 5-year period (January 2002 to December 2006), 284 patients were randomized to have a drain placed (group A), whereas 281 patients were randomized not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, and hospital stay between the 2 groups. RESULTS: There was no mortality in either group and no statistically significant difference in morbidity or hospital stay between the 2 groups. However, postoperative pain was significantly increased in patients who had a drain placed; median visual analog scale (VAS) score was 5 (range 1 to 8) versus 3 (range 1 to 8), in the non-drained group (P < .0001). Interestingly, in 2 of 3 patients in whom a drain was placed against randomization because of bile leak suspicion, a bile leak occurred. CONCLUSIONS: The routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with increased pain. It would be reasonable, however, to leave a drain if there is a worry about an unsolved or potential bile leak, bearing in mind that drain placement, although sometimes providing a false sense of security, does not guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.
RCT Entities:
BACKGROUND: Although the issue of drain use in open cholecystectomy has been adequately addressed by prospective randomized trials, there is lack of evidence on the usefulness of drains in elective laparoscopic cholecystectomy, and the surgeons follow their beliefs and bias on this debate. Therefore, a controlled randomized trial was designed to assess the value of drains in elective laparoscopic cholecystectomy. METHODS: During a 5-year period (January 2002 to December 2006), 284 patients were randomized to have a drain placed (group A), whereas 281 patients were randomized not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, and hospital stay between the 2 groups. RESULTS: There was no mortality in either group and no statistically significant difference in morbidity or hospital stay between the 2 groups. However, postoperative pain was significantly increased in patients who had a drain placed; median visual analog scale (VAS) score was 5 (range 1 to 8) versus 3 (range 1 to 8), in the non-drained group (P < .0001). Interestingly, in 2 of 3 patients in whom a drain was placed against randomization because of bile leak suspicion, a bile leak occurred. CONCLUSIONS: The routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with increased pain. It would be reasonable, however, to leave a drain if there is a worry about an unsolved or potential bile leak, bearing in mind that drain placement, although sometimes providing a false sense of security, does not guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.