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Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

NCT03491878 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Gallbladder Cancer
  • Surgery

Interventions

PROCEDURE

Three dimensional laparoscopic

Three dimensional laparoscopic cholecystectomy including segments IVB and V

PROCEDURE

Open

Open cholecystectomy including segments IVB and V

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-05-01
Completion
2022-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03491878 on ClinicalTrials.gov