Impact of Sarcopenia on Postoperative Outcomes of Patient... | NCT03630978

Studies
Impact of Sarcopenia on Postoperative Outcomes of Patients Undergoing Liver Resection

NCT03630978

Sponsor

San Camillo Hospital, Rome

Status

Completed

Last Update Posted

Dec 24, 2019Actual

Enrollment

251Actual

Phase

Not provided

Conditions

Liver Neoplasms
Sarcopenia
Postoperative Complications

Interventions

Liver resection

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 20, 2019Actual

Completion Date

Dec 20, 2019Actual

First Submitted Date

Aug 11, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2019

Last Update Posted Date

Dec 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will investigate the impact of different biometric parameters (Body mass index, sarcopenia, lean muscle mass, hand-grip strength, gait speed, fat composition) on the postoperative outcomes of patients undergoing liver resections.

Major and minor liver resections will be considered as well as open and minimally invasive techniques.

Benign and malignant indications will be included. Patients characteristics and perioperative variables will be considered for analysis.

Short-term outcomes will be evaluated focusing on 90-days morbidity and mortality and readmission rate.

Detailed Description

According to the null hypothesis, no difference in postoperative morbidity between the two groups would be expected. To calculate sample size, a 42% morbidity rate would be expected in sarcopenic patients while a 22% rate would be expected in the non-sarcopenic group. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 224 subjects. Considering a 10% drop-out rate of patients undergoing explorative laparoscopy or laparotomy without parenchymal resection a total of 249 patients will be required for completion of the study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

251Actual

Label	Type	Description	Intervention Names
Liver resection			Procedure: Liver resection

Name	Type	Description	Arm Group Labels	Other Names
Liver resection	Procedure	Major or minor, open or laparoscopic liver resection	Liver resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity	Patients experiencing medical or surgical complications after surgery	within 90 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Patients dying after surgery	within 90 days after surgery
Readmission rate	patients readmitted to hospital after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing open or laparoscopic liver resection
Patients undergoing major or minor liver resection
Patients undergoing liver resection for primary or secondary liver malignancies
Patients undergoing liver resections for benign diseases (cysts, adenoma, focal nodular hyperplasia, hemangioma) -

Exclusion Criteria:

Patients undergoing extrahepatic resection
Patients undergoing cyst fenestration or biopsies without liver resections
Patients with extrahepatic metastases
Patients undergoing explorative laparoscopy or laparotomy without parenchymal transection -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing liver resection for benign and malignant indications with CT scan imaging availability within 30 days before surgery.

Of all the patients included in the study muscle function tests will be collected including handgrip strength, gait speed and fat composition.

Preoperative antropometric, biochemical and disease presentation characteristics will be collected as well as operative details and postoperative outcomes.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Giuseppe Maria Ettorre, Prof	San Camillo Hospital Spallanzani	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
San Camillo Hospital		Rome		00100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29254263	Result	Zhang G, Meng S, Li R, Ye J, Zhao L. Clinical significance of sarcopenia in the treatment of patients with primary hepatic malignancies, a systematic review and meta-analysis. Oncotarget. 2017 Jul 28;8(60):102474-102485. doi: 10.18632/oncotarget.19687. eCollection 2017 Nov 24.
29149975	Result	Harimoto N, Yoshizumi T, Izumi T, Motomura T, Harada N, Itoh S, Ikegami T, Uchiyama H, Soejima Y, Nishie A, Kamishima T, Kusaba R, Shirabe K, Maehara Y. Clinical Outcomes of Living Liver Transplantation According to the Presence of Sarcopenia as Defined by Skeletal Muscle Mass, Hand Grip, and Gait Speed. Transplant Proc. 2017 Nov;49(9):2144-2152. doi: 10.1016/j.transproceed.2017.09.017.

ID	Term
D008113	Liver Neoplasms
D055948	Sarcopenia
D011183	Postoperative Complications
D006528	Carcinoma, Hepatocellular
D020518	Focal Nodular Hyperplasia

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative