NCT02382952

Brief Summary

The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Status
withdrawn

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

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

March 3, 2015

Last Update Submit

August 3, 2016

Conditions

Surgical AdhesionsBlood Loss, Surgical

Keywords

Abdominal surgeryPelvic surgeryStoma takedownBowel resectionLysis of abdominal adhesions

Outcome Measures

Primary Outcomes (2)

  • Operative Blood Loss

    From start of surgery to wound closure

  • Post-operative Blood Loss

    After surgical closure and drain insertion through drain removal

Study Arms (2)

Differential Dissector

EXPERIMENTAL

For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate.

Device: Differential Dissector

Standard Dissection Method

ACTIVE COMPARATOR

For patients in the control group, blunt dissection will be performed by standard method.

Other: Standard Dissection Method

Interventions

Differential DissectorDEVICE
Differential Dissector
Standard Dissection MethodOTHER
Standard Dissection Method

Eligibility Criteria

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

You may qualify if:

  • Age greater than 18
  • Patient will be undergoing open abdominal surgery
  • Patient willing and able to provide his/her own consent

You may not qualify if:

  • Current alcohol or other substance abuse
  • Current incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tissue AdhesionsBlood Loss, Surgical

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhageIntraoperative Complications

Study Officials

  • Mark Koruda, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share