NCT03958825

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

May 20, 2019

Last Update Submit

September 16, 2020

Conditions

HepatolithiasisLaparoscopic Liver ResectionOpen Liver ResectionEnhanced Recovery

Outcome Measures

Primary Outcomes (1)

  • Hospital duration after operation (days)

    the length of hospital stay

    up to 30 days after liver resection

Secondary Outcomes (12)

  • Readmission percentage

    up to 30 days after liver resection

  • Total morbidity

    up to 1 year after liver resection

  • Composite endpoint of liver surgery specific morbidity

    up to 1 year after liver resection

  • Hospital and societal costs

    up to 1 year after liver resection

  • Incidence of incisional hernias

    up to 1 year after liver resection

  • +7 more secondary outcomes

Study Arms (2)

open left hepatic sectionectomy

ACTIVE COMPARATOR

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

Procedure: open left hepatic sectionectomy

laparoscopic hepatic sectionectomy

EXPERIMENTAL

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

Procedure: laparoscopic hepatic sectionectomy

Interventions

laparoscopic hepatic sectionectomyPROCEDURE

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

Also known as: open left hepatic sectionectomy
laparoscopic hepatic sectionectomy
open left hepatic sectionectomyPROCEDURE

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

open left hepatic sectionectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second hospital of Anhui Medical University,

Hefei, Anhui, 230061, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38383461DERIVED

Study Officials

  • hui hou, master

    Second Affiliated Hospital of Anhui Medical University

    STUDY CHAIR

Central Study Contacts

hui s hou, master

CONTACT

+8615856943673aydpanshubo@126.com

shubo s pan, Doctor

CONTACT

+8615856943673aydpanshubo@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgery

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

August 10, 2019

Primary Completion

December 26, 2022

Study Completion

June 1, 2023

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)