Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Sensory nerve coaptation

• Registration Number: NCT04093999
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2019-09
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Innervated DIEP flaps	Sensory nerve coaptation	Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands