Evidence map›Paper›PMID 38401421›Full record

Trial reportBreast (Edinburgh, Scotland)2024

The efficacy of sensory nerve coaptation in DIEP flap breast reconstruction - Preliminary results of a double-blind randomized controlled trial.

Jeske M Bubberman, Lloyd Brandts, Sander M J van Kuijk, René R W J van der Hulst, Stefania M H Tuinder

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07308275 (Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07308275 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry

TypeinterventionalSponsorFakultas Kedokteran Universitas IndonesiaRan2025 to 2027Enrolled28ConditionsBreast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve RegenerationArmsAutologous Breast Reconstruction With Direct Neurotization, Autologous Breast Reconstruction without Neurotization
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Pushing the DIEP Envelope: Where Are We Now?Journal of clinical medicine · 2025
    Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Jeske M BubbermanDepartment of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; GROW - Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
Lloyd BrandtsDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
Sander M J van KuijkDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
René R W J van der HulstDepartment of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; GROW - Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
Stefania M H TuinderDepartment of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; GROW - Research Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands. Electronic address: s.tuinder@mumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSensory nerve coaptation has great potential to restore sensation after autologous breast reconstruction. However, blinded and randomized studies are lacking. We therefore present the preliminary results of our ongoing double-blinded randomized controlled trial that compares sensory recovery of innervated versus non-innervated DIEP flaps.

methodsPatients who underwent DIEP flap breast reconstruction between July 2019 and February 2022 were included and randomized. The anterior cutaneous branch of the second or third intercostal nerve was coapted. Pre- and postoperative sensory testing was performed with Semmes-Weinstein Monofilaments, Pressure Specified Sensory Device, and a thermostimulator, for tactile and temperature thresholds.

resultsThis interim analysis comprised 41 patients contributing 29 innervated and 38 non-innervated breasts. At 24 months of follow-up, the mean monofilament value of the flap skin was lower in innervated than in non-innervated flaps (4.48 vs. 5.20, p = 0.003). Touch thresholds were lower the center of the innervated flaps (47.8 vs. 71.2 g/mm

conclusionsThese preliminary results indicate superior sensibility and recovery of protective sensation in innervated compared with non-innervated DIEP flaps. Although the results of the completed trial must be awaited to establish the full clinical impact, including highly anticipated quality of life outcomes, we encourage continuation of scientific and clinical efforts in this promising technique.

Indexed as

Breast NeoplasmsMammaplastyBreastDouble-Blind MethodFemaleHumansQuality of LifeTouchAutologous breast reconstructionBreast cancerDIEP flapSensationSensibility

Identifiers

PMID38401421
PMCPMC10904190

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.