Clinical trial · Observational
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction
Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sensory nerve coaptation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Innervated DIEP flaps
- description
- Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.
- interventionNames
- Procedure: Sensory nerve coaptation
- label
- Noninnervated DIEP flaps
- description
- Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.
Primary outcomes (1)
- measure
- Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
- timeFrame
- Through study completion up to 36 months postoperatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available