Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (DIEP) flap breast reconstruction with additional sensory nerve coaptation.

Patients in this group underwent immediate or delayed, unilateral or bilateral deep inferior epigastric artery perforator (DIEP) flap breast reconstruction without sensory nerve coaptation.

A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.

Sensory nerve coaptation

René van der Hulst, MD, PhD

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated DIEP flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.

Nerve Coaptation in DIEP Flap Breast Reconstruction

Sensory Recovery of the Breast Following Innervated and Non-innervated DIEP Flap Breast Reconstructions

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.

Maastricht University Medical Center

Prof. Dr.

Patients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction

No preoperative vessel mapping will be done

Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction

Preoperative CT angiography

No imaging will be done to map blood vessels prior to surgery

No Preoperative Imaging

David W Mathes, MD

This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).

CT-Angiography Prior to DIEP Flap Breast Reconstruction

CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial

Time required to perform breast reconstruction with DIEP flap

University of Colorado, Denver

Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.

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

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.

Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

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

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.

Head of the Plastic Surgery department

Breast Diseases

Skin Diseases

No preoperative imaging is performed for this group

Patients randomized to this group will undergo a preoperative CTA scan.

Patients randomized to this group will undergo a preoperative MRA scan.

Joan Lipa, MD, MSc

The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.

This study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either CTA or MRA with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control) preoperatively. An operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned for controls.

Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. Groups will be compared in terms of all variables measured.

Preoperative Imaging in DIEP Flap Breast Reconstruction

Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes

Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.

Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.

Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded

Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.

Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration.

The costs of medical imaging and operating expenses will be calculated and compared between study groups.

Canadian Breast Cancer Foundation

Sunnybrook Health Sciences Centre

pathway

Bernard T Lee, MD

Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Intraoperative Pathway in DIEP Flap Breast Reconstruction

Beth Israel Deaconess Medical Center

Assistant Professor in Surgery

Pre Pathway

Post Pathway

Total

Age, Categorical

Female

Male

Sex/Gender, Customized

More patient enrollment is necessary to ascertain long term outcomes

Bernard Lee

Operative Time

Overall Study

Infections

Symptoms and General Pathology

Communicable Diseases

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Cefazolin

Antibiotics, Antitubercular

In prophylactic antibiotics for drain group (PAD) (n = 15), prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative for 10-14 days when the drains were removed from the breast and abdomen.

In the 3-day prophylactic antibiotics group (PA3) (n = 11), prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in peri-operative period, and 6-hourly thereafter for 3 days.

In the 1-day prophylactic antibiotics group (PA1) (n = 82), patients received prophylactic cefazolin 1000 mg 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative period and antibiotics were discontinued within 24 hours of surgery.

Prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative care. Different discontinued duration of antibiotics was divided to 3 groups in one day, 3 days and until to drain removal.

prophylactic antibiotics duration

Chien-Liang Fang, Director

Background: There is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy. We try to standardize prophylactic antibiotics use during breast reconstruction with deep inferior epigastric perforator flap following mastectomy.

Methods: This retrospective case series involved 108 patients who underwent immediate breast reconstruction with deep inferior epigastric perforator flap in Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019. Patients were divided into three groups based on prophylactic antibiotic duration: 1 day, 3 days and \>7 days for patients with drains Data were analyzed between January and April, 2021.

Deep Inferior Epigastric Artery Flap for Breast Reconstruction

Division of Plastic and Reconstruction Surgery

Prophylactic antibiotics discontinued within 24 hours after deep inferior epigastric perforator flap reconstruction can prevent surgical site infection occurrence.

Infection rate of surgical wounds of breast and abdomen.

Chiayi Christian Hospital

Patients who have undergone mastectomy for breast cancer prior to implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program

Patients who have undergone mastectomy for breast cancer after implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Outcomes of a Deep Inferior Epigastric Perforator Flap Program

Breast Q, Michigan Breast Outcomes Survey

Professor of Surgery

Ischemia

Mechanical ischemic preconditioning: Performing series of reperfusion ischemia on the flap pedicle, before cold ischemia of the flap (flap harvesting before vascular mechanical anastomoses at the recipient site)

* 10 min of clamping with single-use microvascular forceps
* 10 min declamping
* 10 min of tightening with pliers
* 10 min declamping Either preconditioning for 40 minutes, simulating 2 cycles of ischemia reperfusion prior to flap harvesting and cold ischemia before revascularization.

Mechanical ischemic preconditioning of diep-type flap

Sarra CRISTOFARI, MD, PhD

Michael ATLAN, PU-PH

Sara CRISTOFARI, MD, PhD

Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast cancer is around 85%. Surgical treatment by total mastectomy concerns around 30% of cases. For patients who have been treated for breast cancer by total mastectomy, secondary breast reconstructions are often carried out via excess abdominal fat flaps of DIEP type.

Postoperative partial fat necrosis is a common complication of breast reconstruction. This necrosis is qualified as pathological when it is palpable or when there are symptoms leading to pain, deformation, or leakage. Necrosis occurs in the first 6 months after surgery. Diagnosis is carried out by the detection of a nodule of fat necrosis measuring at least 5 mm on the ultrasound.

Partial flat necrosis results from ischemia reperfusion (IR) to the fat tissues during reconstruction. IR leads to inflammatory lesions, edema, capillary occlusion that can lead to tissue necrosis. The deleterious impact of IR has been shown on the organs (liver, kidney) on muscular, cutaneous and adipose tissues in humans and animals.

Ischaemic preconditioning is a procedure used in organ transplant surgery, allowing a better tolerance of the graft for ischemia reperfusion, without further complications. It is used in usual practice for kidney or liver transplants; short cycles of ischemia reperfusion are carried out on the organ pedicle before harvesting using cold ischemia (out of the donor's body) pre-transplant.

Ischaemic preconditioning before reconstruction has been studied in animal models but not in human reconstruction surgery, although it seems to be beneficial. For patients undergoing total mastectomy after being diagnosed with breast cancer, we hypothesize that ischaemic preconditioning, usually used for organ transplants, could decrease adipose tissue lesions caused by ischemia reperfusion after breast reconstruction with DIEP (deep inferior epigastric perforator) flaps.

This is a phase 2 monocentric study, following the 2 step Simon Minimax design.

We will be carrying out cycles of ischemic preconditioning for 40 minutes, simulating 2 cycles of ischemia-reperfusion (per 10min) prior to flap harvesting and cold ischemia before revascularization.

The pre operation visit will occur between M3 and M1 before the scheduled operation date. The visit will be carried out by the surgeon who will inform the patient of the study.

The inclusion visit (D0) will be carried out by the investigator the day before surgery (collection of signed consent form). The surgery will be carried out as usual: breast reconstruction with DIEP type flap. Modification of the intervention for the study: preconditioning of the flap (for patients) and 3 biopsies.

During post-operative hospitalization, usual visits will be carried out twice a day (not specifically for the study) by an doctor (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation).

After postoperative discharge, 4 follow up visits are planned which correspond to 3 postoperative consultations at the hospital (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation) at D21 (+/- 2 days), M1 (+/- 2 days), M3 (+/- 15 days, same assessment plus search for palpable, painful or deforming nodules) and M6 (+/- 15 days, last visit) plus a mammary ultrasound (this is the only supplementary assessment carried out for the study, Tenon hospital).

BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.

Number of successes of the technique defined by the absence of pathological postoperative fat necrosis to evaluate the efficacy of ischaemic preconditioning on the tolerance of the adipose tissue to the ischemia-reperfusion of DIEP flaps

proportion of patients with skin necrosis

* Skin infection
* Skin necrosis of the flap
* Scar disunion

Proportion of overall reconstruction failure (need to remove the flap for total necrosis)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT03428789	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
CT-Angiography Prior to DIEP Flap Breast Reconstruction	NCT02883387	Breast Cancer	Preoperative CT... No Preoperative...	18 Years - 75 Years	University of Colorado, Denver
Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT03428789	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT04093999	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
Preoperative Imaging in DIEP Flap Breast Reconstruction	NCT02111239	Breast Cancer	CTA MRA	18 Years -	Sunnybrook Health Sciences Centre
Intraoperative Pathway in DIEP Flap Breast Reconstruction	NCT00543764	Breast Cancer	pathway	-	Beth Israel Deaconess Medical Center
Deep Inferior Epigastric Artery Flap for Breast Reconstruction	NCT05088239	Breast Cancer Perforator Flap Anti-Infectives... Infections	prophylactic an...	24 Years - 63 Years	Chiayi Christian Hospital
Preoperative Imaging in DIEP Flap Breast Reconstruction	NCT02111239	Breast Cancer	CTA MRA	18 Years -	Sunnybrook Health Sciences Centre
Outcomes of a Deep Inferior Epigastric Perforator Flap Program	NCT00543907	Breast Cancer		20 Years - 70 Years	Beth Israel Deaconess Medical Center
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT04093999	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
Nerve Coaptation in DIEP Flap Breast Reconstruction	NCT03428789	Breast Cancer	Sensory nerve c...	18 Years -	Maastricht University Medical Center
Preoperative Imaging in DIEP Flap Breast Reconstruction	NCT02111239	Breast Cancer	CTA MRA	18 Years -	Sunnybrook Health Sciences Centre
BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.	NCT05373069	Breast Cancer	Mechanical isch...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for diep flap

Every month we try and update this database with for diep flap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for diep flap

Every month we try and update this database with for diep flap cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for diep flap cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.