Open Versus Laparoscopic Left Hepatic Sectionectomy

NCT ID: NCT03958825

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2023-06-01

Brief Summary

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Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.

Detailed Description

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The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.

Conditions

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Hepatolithiasis Laparoscopic Liver Resection Open Liver Resection Enhanced Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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open left hepatic sectionectomy

patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme

Group Type ACTIVE_COMPARATOR

open left hepatic sectionectomy

Intervention Type PROCEDURE

patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme

laparoscopic hepatic sectionectomy

patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme

Group Type EXPERIMENTAL

laparoscopic hepatic sectionectomy

Intervention Type PROCEDURE

patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme

Interventions

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laparoscopic hepatic sectionectomy

patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme

Intervention Type PROCEDURE

open left hepatic sectionectomy

patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme

Intervention Type PROCEDURE

Other Intervention Names

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open left hepatic sectionectomy

Eligibility Criteria

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Inclusion Criteria

* Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver
* Able to understand the nature of the study and what will be required of them
* Men and non-pregnant,non-lactating women between age 18-80
* BMI between 18-35
* Patients with ASA I-II-III

Exclusion Criteria

* Inability to give written informed consent
* Patients undergoing liver resection other than left lateral hepatic sectionectomy
* Patients with ASA IV-V Underlying liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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hui hou

general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hui hou, master

Role: STUDY_CHAIR

Second Affiliated Hospital of Anhui Medical University

Locations

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The second hospital of Anhui Medical University,

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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hui s hou, master

Role: CONTACT

+8615856943673 ext. +8615856943673

shubo s pan, Doctor

Role: CONTACT

+8615856943673 ext. +8615856943673

Facility Contacts

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shubo pan

Role: primary

+8615856943673 ext. +8615856943673

hui hou

Role: backup

+8615856943673 ext. +8615856943673

References

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Pan SB, Wu CL, Zhou DC, Xiong QR, Geng XP, Hou H. Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial. Trials. 2024 Feb 22;25(1):137. doi: 10.1186/s13063-023-07476-w.

Reference Type DERIVED
PMID: 38383461 (View on PubMed)

Other Identifiers

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520

Identifier Type: -

Identifier Source: org_study_id

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