NCT02365194

Brief Summary

A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at a safety-net hospital results in a higher proportion of patients being hernia- and complication-free 2 years after surgical consultation.

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
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

February 2, 2015

Last Update Submit

April 30, 2018

Conditions

Hernia, VentralWeight Loss

Keywords

Ventral HerniaPrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who are hernia- and complication-free

    2 years after enrollment

Secondary Outcomes (8)

  • Weight loss (number of participants with weight loss of at least 7%)

    6 months after enrollment

  • Receipt of elective or emergency surgery

    6 months after enrollment

  • surgery-related complications (number of patients who developed infections or other complications related to the surgery)

    2 years after surgery

  • hernia-related complications (number of patients who developed complications from their hernia)

    2 years after surgery

  • Functional Status (Quality of life questionnaire responses)

    2 years after surgery

  • +3 more secondary outcomes

Study Arms (2)

Prehabilitation

OTHER

physical conditioning and weight loss intervention done pre-operatively

Behavioral: Prehabilitation

Standard Counseling

OTHER

initial clinic counseling

Behavioral: Standard counseling

Interventions

PrehabilitationBEHAVIORAL

information included in arm description

Prehabilitation
Standard counselingBEHAVIORAL

information included in arm description

Standard Counseling

Eligibility Criteria

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

You may qualify if:

  • Patient desires an elective surgical repair
  • Diagnosis of a ventral hernia with width on CT scan of 3-20 cm in diameter
  • Age 18 years or greater
  • Able to give informed consent
  • BMI of 30-40 kg/m2
  • Surgical candidate based upon surgeon assessment

You may not qualify if:

  • Patient has a severe comorbid condition likely to limit survival to \< 2 years
  • Patient has cirrhosis with or without ascites
  • Patient has a bowel obstruction, strangulation, peritonitis, or perforation
  • Patient has an indication for urgent surgery determined by surgeon such as full-thickness skin breakdown, enterocutaneous fistula, intermittent incarceration, or severe symptoms
  • Patient has a local or systemic infection
  • Patient is a prisoner
  • Patient is pregnant or intends to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Related Publications (2)

  • Bernardi K, Olavarria OA, Dhanani NH, Lyons N, Holihan JL, Cherla DV, Berger DH, Ko TC, Kao LS, Liang MK. Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194). Ann Surg. 2022 Feb 1;275(2):288-294. doi: 10.1097/SLA.0000000000004486.

    PMID: 33201119DERIVED

  • Liang MK, Bernardi K, Holihan JL, Cherla DV, Escamilla R, Lew DF, Berger DH, Ko TC, Kao LS. Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial. Ann Surg. 2018 Oct;268(4):674-680. doi: 10.1097/SLA.0000000000002961.

    PMID: 30048306DERIVED

MeSH Terms

Conditions

Hernia, VentralWeight Loss

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBody Weight ChangesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mike K Liang, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 18, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

US(1)