Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorDu Zhenggui

About this trial

Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery, radiotherapy, chemotherapy, and endocrine therapy, among which surgery is the key. Postoperative care is also very important. Traditional breast surgery requires long-term placement of drainage tubes after the operation. However, long-term placement of drainage tubes increases the incidence of postoperative complications such as infection and delayed wound healing, prolongs hospital stays, increases economic burden, and also affects the aesthetic outcome. Our team has innovatively adopted the "reverse-sequence" endoscopic nipple-sparing-mastectomy with direct-to-implant breast reconstruction. This method is highly efficient and safe, with no incisions on the surface of the breast, reducing the risk of incision dehiscence and the probability of flap ischemia and necrosis. Based on this, our team proposes to appropriately relax the drainage criteria and remove the drainage tube earlier under the premise of ensuring the sterility of the effusion, and preliminary findings show that patients have better postoperative aesthetic outcomes, with a lower incidence of flap infection, ischemia, and necrosis than expected, and the degree of breast deformation caused by radiotherapy is also reduced. However, there is still controversy over the pros and cons of drainage criteria. Some scholars believe that strict drainage criteria can reduce the risk of infection and implant displacement, and plastic surgeons are more concerned about the impact of long-term tube placement on aesthetic outcomes and quality of life. Currently there is a lack of large sample, multicenter, randomized controlled studies to provide high - level evidence. Therefore, our team plans to conduct a national multicenter, open, randomized controlled study to compare the advantages and disadvantages of the two drainage methods under the premise of not reducing postoperative surgical and oncological safety, in order to explore the optimal timing for drain removal and improve patients' satisfaction with the reconstructed breast.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-70 years (inclusive);

Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;

Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;

Patients with a maximum tumor diameter≤5 cm (before/after neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;

Disqualifiers

History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);

Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;

Advanced tumor stage (M1);

Breast cancer during pregnancy or lactation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drain Removal Timing After Endoscopic Breast Reconstruction Surgery

    Procedure/Surgery

    The optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery.

Treatment groups

379 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Aesthetic outcome evaluation--BREAST-Q scores

The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores

Time frame
Preoperative (baseline), 3-month postoperative

Secondary outcomes

1

Drainage tube indwelling duration

The duration of drainage tube indwelling refers to the total time from the postoperative insertion of the drainage tube to its removal, measured in days

Time frame
Perioperative
2

Quality of Life--EORTC Quality of Life scores

EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms.

Time frame
14 days postoperative and 3 months postoperative
3

wound care

The differences in the number of dressing changes and wound care procedures.

Time frame
3 months postoperative
4

Complications

Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission

Time frame
3 months, 1 year and 2 years postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Du Zhenggui

Lead sponsor

West China Hospital

Sponsor institution

The First Affiliated Hospital of Shanxi Medical University

Collaborator

West China Fourth Hospital

Collaborator

Bethune Hospital of Shanxi Medical University

Collaborator

The First Hospital of Jilin University

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Suining Central Hospital

Collaborator

The Second Affiliated Hospital of Kunming Medical University

Collaborator

Zhengzhou Central Hospital

Collaborator

Deyang People's Hospital

Collaborator

Suzhou Municipal Hospital

Collaborator

Chengdu Fifth People's Hospital

Collaborator

Hunan University of Traditional Chinese Medicine

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Fourth People's Hospital of Sichuan Province

Collaborator

China-Japan Union Hospital, Jilin University

Collaborator

Guangzhou First People's Hospital

Collaborator

Xinjiang Medical University Affiliated Cancer Hospital

Collaborator

Fujian Medical University Union Hospital

Collaborator

Central Hospital of Taiyuan

Collaborator

West China Tianfu Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: