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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Three dimensional laparoscopic cholecystectomy including segments IVB and V
Open cholecystectomy including segments IVB and V
Tongji Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Operation time
Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.
Time frame: 24 months
Estimated blood loss
EBL is defined as the blood loss during the surgical procedure
Time frame: 24 months
Intraoperative blood transfusion
IBT is defined as whether the subjects receive blood transfusion during the surgical procedure
Time frame: 24 months
Length of stay
LOS is defined as the days between the surgery and hospital discharged
Time frame: 24 months
Complication rate
Complication rate is defined as the number of subjects developed complication divided the total subjects number
Time frame: 24 months
R0 rescetion rate
R0 rescetion rate for the carcinoma
Time frame: 24 months
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