Surgery Clinical Trial
Official title:
Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial
Introduction: Surgery is the only potential curative approach for the highly lethal
gallbladder carcinoma. The laparoscopic surgery has developed rapidly since invented. As a
kind of minimally invasive surgery, laparoscopic cholecystectomy including segmentg IVB and V
is preferred by most of surgeons. There have been studies comparing intraoperative blood
loss, postoperative morbidity, length of hospital stay and costs of laparoscopic
cholecystectomy over open surgery. However, randomized controlled trials are still lacking
but clearly required to reveal whether the laparoscopic approach or the open surgery is the
better option for treating gallbladder carcinoma. We hypothesize that incidence of
postoperative complications is lower, and time to functional recovery is shorter after
laparosopic compared with open approach, even in an enhanced recovery setting.
Methods/design: We designed this prospective, randomized, controlled trial with two treatment
approaches, laparoscopic versus open surgery for gallbladder carcinoma. The trial hypothesis
is that laparoscopic approach has advantages in postoperative recoveries and be equivalent in
operation time, oncological results and long-term follow-up compared with open counterpart.
The duration of the entire trial is four years including prearrangement, follow-up and
analyses.
Discussion: Although several studies have discussed different surgical approaches for
gallbladder carcinoma treatment, this trial will be a thorough RCT comparing laparoscopic and
open surgery for gallbladder carcinoma.
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