NCT00905320

Brief Summary

This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

7.2 years

First QC Date

May 18, 2009

Last Update Submit

April 19, 2021

Conditions

Hernia

Keywords

Hernia repair

Outcome Measures

Primary Outcomes (1)

  • Post-op Pain

    Short-Form McGill Pain Questionnaire (SFMP)

    12 Weeks

Secondary Outcomes (1)

  • Hernia recurrence

    2 Years

Study Arms (2)

Metallic Fasteners and Sutures

ACTIVE COMPARATOR

Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures

Procedure: Metallic Fasteners and Sutures

Metallic Fasteners Alone

EXPERIMENTAL

Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone

Procedure: Metallic Fasteners Alone

Interventions

Metallic Fasteners and SuturesPROCEDURE

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.

Also known as: Metallic fasteners and sutures.
Metallic Fasteners and Sutures
Metallic Fasteners AlonePROCEDURE

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Also known as: Metallic fasteners alone for mesh fixation
Metallic Fasteners Alone

Eligibility Criteria

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

You may qualify if:

  • Demographics:
  • Age ≥ 18 years old
  • If female, negative pregnancy test
  • Pre-Operative Findings:
  • Presence of an abdominal hernia associated with previous surgical incision
  • Midline ventral\\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.
  • CT scan, MRI, Ultrasound
  • No evidence of incarceration, strangulation
  • Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)
  • Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter

You may not qualify if:

  • Pre-Operative History:
  • Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
  • History of the following:
  • Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
  • Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired
  • Allergy to products used in hernia repair including surgical mesh
  • Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity
  • Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)
  • Presence of simultaneous intra-abdominal infection
  • Simultaneous presence of a bowel obstruction
  • History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
  • Intra-operative Findings:
  • Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
  • Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Hernia

Interventions

Sutures

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Don Selzer, MD

    Indiana University Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

September 1, 2009

Primary Completion

November 21, 2016

Study Completion

November 21, 2018

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)