NCT04093999

Brief Summary

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

September 17, 2019

Last Update Submit

September 19, 2019

Conditions

Breast Cancer

Keywords

Breast reconstructionDIEP flapSensory recoveryBreast sensationNerve coaptation

Outcome Measures

Primary Outcomes (1)

  • Mean monofilament value as a measure for the sensory recovery of the reconstructed breast

    The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.

    Through study completion up to 36 months postoperatively

Secondary Outcomes (1)

  • Mean monofilament value as a measure for the sensory recovery of the reconstructed breast

    Through study completion up to 36 months postoperatively

Study Arms (2)

Innervated DIEP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.

Procedure: Sensory nerve coaptation

Noninnervated DIEP flaps

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.

Interventions

Sensory nerve coaptationPROCEDURE

A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.

Also known as: Neurotization, Reinnervation, Neurorrhaphy
Innervated DIEP flaps

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients of 18 years or older.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In this prospective study, patients who underwent an innervated or noninnervated DIEP flap breast reconstruction between August 2016 and August 2018 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between August 2016 and August 2019.

You may qualify if:

  • Female patients 18 years or older
  • Unilateral or bilateral DIEP flap breast reconstruction
  • Returned for follow-up between August 2016 and August 2019
  • Informed consent

You may not qualify if:

  • Total flap loss complication
  • Flaps that required a take-back
  • Follow-up less than six months postoperatively
  • Only one postoperative measurement at less than 12 months follow-up
  • Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • René van der Hulst, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Plastic Surgery department

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 18, 2019

Study Start

August 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)