Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2015-09-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Innervated DIEP flaps
Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (DIEP) flap breast reconstruction with additional sensory nerve coaptation.
Sensory nerve coaptation
A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.
Non-innervated DIEP flaps
Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (DIEP) flap breast reconstruction without sensory nerve coaptation.
No interventions assigned to this group
Interventions
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Sensory nerve coaptation
A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between September 2015 and July 2017
* Informed consent
Exclusion Criteria
* Flaps that required a take-back
18 Years
FEMALE
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Rene van der Hulst
Prof. Dr.
Principal Investigators
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René van der Hulst, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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METC 16-4-147
Identifier Type: -
Identifier Source: org_study_id
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