Breast CancerNCT04093999
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sensory nerve coaptation
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2016to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction
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
- Breast Cancer
- Being tested
- Sensory nerve coaptation
- Keywords
- Breast reconstruction, DIEP flap, Sensory recovery, Breast sensation, Nerve coaptation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory nerve coaptationProcedure or surgery
Also called Neurotization, Reinnervation, Neurorrhaphy
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.
| Study group | Role | What they receive |
|---|---|---|
| Innervated DIEP flaps | Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Through study completion up to 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Aug 2016
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene van der Hulst, Maastricht University Medical Center
- Investigators
- René van der Hulst, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093999
- Sponsor's protocol ID
- METC 16 - 4 - 147
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04093999
- Acronym / sponsor ID
- METC 16 - 4 - 147
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, DIEP flap, Sensory recovery, Breast sensation, Nerve coaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innervated DIEP flaps | – | Procedure: Sensory nerve coaptationPatients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory nerve coaptationAlso: Neurotization, Reinnervation, NeurorrhaphyA 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. | Procedure or surgery | Innervated DIEP flaps |
Primary outcome
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
Time frame: 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.
1 secondary outcome
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
Time frame: Through study completion up to 36 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René van der Hulst, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast (time frame: Through study completion up to 36 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.