Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04093999

Collaborator

(none)

126

Enrollment

Location

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Sensory nerve coaptation

Study Design

Study Type:

Observational

Actual Enrollment :

126 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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. Other Names: Neurotization Reinnervation Neurorrhaphy
Noninnervated DIEP flaps Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.

Arm

Intervention/Treatment

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

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.

Other Names:

Neurotization

Reinnervation

Neurorrhaphy

Noninnervated DIEP flaps

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

Outcome Measures

Primary Outcome Measures

Mean monofilament value as a measure for the sensory recovery of the reconstructed breast [Through study completion up to 36 months postoperatively]
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.

Secondary Outcome Measures

Mean monofilament value as a measure for the sensory recovery of the reconstructed breast [Through study completion up to 36 months postoperatively]
The sensory recovery of the donor site to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Four areas of the donor site were tested, two areas above and two areas below the scar. Mean monofilament values were calculated for the total donor site and compared between groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229 HX

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: René van der Hulst, MD, PhD, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rene van der Hulst, Head of the Plastic Surgery department, Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT04093999

Other Study ID Numbers:

METC 16 - 4 - 147

First Posted:

Sep 18, 2019

Last Update Posted:

Sep 23, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rene van der Hulst, Head of the Plastic Surgery department, Maastricht University Medical Center

Breast reconstruction

Study Results

No Results Posted as of Sep 23, 2019