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Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

A Prospective Cohort Study: Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03297099
Enrollment
60
Registered
2017-09-29
Start date
2017-06-01
Completion date
2020-06-01
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatolithiasis

Keywords

robot-assisted laparosocpic, hepatectomy

Brief summary

The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by contrast of open procedures.

Detailed description

Robot-assisted laparoscopic operation is a safe and feasible treatment for selected patients with complicated hepatolithiasis, with an advantage over open surgery in the field of intraoperative blood loss, less hilar occlusion, lower transfusion rate, less postoperative hospital stay.

Interventions

PROCEDURERobot-assisted Laparoscopic operation

Thirty patients with hepatolithiasis were selected and divided into robot group as described in the detailed description. Under general anesthesia, the patient was placed in a supine 30-degree reverse Trendelengburg position with both legs separating. The surgeon work on the console, and assist surgeon stand between legs. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.

PROCEDUREopen surgery

surgery group as described in the detailed description.Open surgery was performed under general anesthesia with the patient in the supine position. Routinely, a reversed L-shape incision was performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.

Sponsors

Southwest Hospital, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with intrahepatic bile duct stones or hepatolithiasis. 2. Liver function \> Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved 3. Age: Between 18 to 70 years 4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis 5. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved 6. Other organ lesions and previous biliary tract operation is not the absolute

Exclusion criteria

7. Written informed consent

Design outcomes

Primary

MeasureTime frameDescription
initial stone clearance rateduring the operationrate of the removal of the stones from intrahepatic bile duct identified by ultrasonic or computed tomography or magnetic resonance

Secondary

MeasureTime frameDescription
intraoperative parametersduring the operationoperation time, intraoperative blood loss, rate of blood transfusion

Other

MeasureTime frameDescription
postoperative complicationsDuration hospitalization(an expected average of 7 days)ascites, pleural effusion,cardiopulmonary insufficiency,mortality, postoperative liver function failure.

Countries

China

Contacts

Primary ContactShuguo Zheng
shuguozh@yahoo.com.cn0086-13508308676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026