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

NCT07237828 | Not Yet Recruiting DMC

• 1 other identifier: 2025(440)
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Minimal invasive surgery; Nipple-sparing mastectomy; Endoscopic surgery

Outcome Measures

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

  Preoperative (baseline), 3-month postoperative

Secondary Outcomes (13)

• Drainage tube indwelling duration

  Perioperative

• Quality of Life--EORTC Quality of Life scores

  14 days postoperative and 3 months postoperative

• wound care

  3 months postoperative

• Complications

  3 months, 1 year and 2 years postoperative

• Aesthetic outcome evaluation--BREAST-Q scores

  2 years postoperative

Study Arms (2)

Intervention group

EXPERIMENTAL

Remove drainage tubes on postoperative day 5

Procedure: Drain Removal Timing After Endoscopic Breast Reconstruction Surgery

Control group

NO INTERVENTION

Remove drainage tubes when the daily drainage volume is less than 30 ml/day for two consecutive days after surgery.

Interventions

Drain Removal Timing After Endoscopic Breast Reconstruction Surgery PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• BMI \< 40 kg/m²;
• Implant volume \< 600 mL;
• Patients who are able and willing to sign the informed consent form.

You may not qualify if:

• 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;
• Scars below the nipple level and a history of previous radiotherapy;
• Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;
• HbA1c \> 7.5%;
• Active smoking history (≥20 cigarettes per day);
• Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;
• Currently participating in other clinical studies that may affect participation in this trial.
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Du Zhenggui: lead
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• West China Fourth Hospital, Sichuan University: 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
• The 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 of Sichuan University: collaborator

Study Sites (1)

West China Hospital, SiChuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (6)

• Feng Y, Xie Y, Liang F, Zhou J, Yang H, Qiu M, Zhang Q, Liu Y, Liang P, Du Z. Twenty-four-hour discharge of patients after endoscopic nipple-sparing mastectomy and direct-to-implant breast reconstruction: safety and aesthetic outcomes from a prospective cohort study. Br J Surg. 2024 Jan 3;111(1):znad356. doi: 10.1093/bjs/znad356. No abstract available.

  PMID: 37991082 BACKGROUND

• Zhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.

  PMID: 38348883 BACKGROUND

• Yang H, Liang F, Xie Y, Qiu M, Du Z. Single axillary incision reverse-order endoscopic nipple/skin-sparing mastectomy followed by subpectoral implant-based breast reconstruction: Technique, clinical outcomes, and aesthetic results from 88 preliminary procedures. Surgery. 2023 Sep;174(3):464-472. doi: 10.1016/j.surg.2023.05.037. Epub 2023 Jul 7.

  PMID: 37422354 BACKGROUND

• Zhang S, Xie Y, Liang F, Wang Y, Wen N, Zhou J, Feng Y, Liu X, Lv Q, Du Z. Video-assisted Transaxillary Nipple-sparing Mastectomy and Immediate Implant-based Breast Reconstruction: A Novel and Promising Method. Aesthetic Plast Surg. 2022 Feb;46(1):91-98. doi: 10.1007/s00266-021-02527-6. Epub 2021 Aug 23.

  PMID: 34424367 BACKGROUND

• Jia-Jian C, Nai-Si H, Jing-Yan X, Ben-Long Y, Guang-Yu L, Gen-Hong D, Zhi-Min S, Jiong W. Current Status of Breast Reconstruction in Southern China: A 15 Year, Single Institutional Experience of 20,551 Breast Cancer Patients. Medicine (Baltimore). 2015 Aug;94(34):e1399. doi: 10.1097/MD.0000000000001399.

  PMID: 26313786 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenggui Du, Dr

CONTACT

+86 13880768222; docduzg@163.com

Tianyuan Li

CONTACT

+86 15510183188; Lity0526@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): June 30, 2032
• Last Updated: November 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of relevant research outputs, such as academic papers and books.
• Access Criteria: When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.

Locations

CN (1)