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

Official title

Drainage Removal After Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy With Direct-to-Implant Prepectoral Breast Reconstruction on Postoperative Safety and Patient Satisfaction : A National Multicenter, Open, Randomized Controlled Study

Overview

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.

Detailed description

This study is a multicenter, open, randomized controlled trial. Prior to group allocation, participants were stratified by axillary lymph node dissection. The proportion of patients undergoing axillary lymph node dissection is 25%, while the proportion of patients not undergoing axillary lymph node dissection is 75%. Following stratification, participants within each stratum were randomized in a 3:1 ratio to the intervention or control groups. The target sample size is 379 participants, comprising 95 in the ALND group (71 intervention, 24 control) and 284 in the non-ALND group (213 intervention, 71 control).

An interim analysis will occur 1 year after study initiation and 1 month post-enrollment completion. Final analysis follows 5-year postoperative follow-up for all participants. Categorical variables will be analyzed using chi-square or Fisher's exact tests; continuous variables via t-tests, ANOVA, or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. Survival outcomes will employ Kaplan-Meier curves with log-rank testing.

Interventions

• Procedure Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
  The optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery.

Primary outcome measures

• Aesthetic outcome evaluation--BREAST-Q scores [Time frame: Preoperative (baseline), 3-month postoperative]

Secondary outcome measures (12)

• Drainage tube indwelling duration [Time frame: Perioperative]
• Quality of Life--EORTC Quality of Life scores [Time frame: 14 days postoperative and 3 months postoperative]
• wound care [Time frame: 3 months postoperative]
• Complications [Time frame: 3 months, 1 year and 2 years postoperative]
• Aesthetic outcome evaluation--BREAST-Q scores [Time frame: 2 years postoperative]
• Quality of Life--BREAST-Q scores [Time frame: Preoperative (baseline), 3 months and 2 years postoperative]
• Surgical margin involvement [Time frame: 2-3 weeks postoperative after paraffin-embedded pathological report available]
• The total volume of drainage [Time frame: Perioperative]
• Aesthetic outcome evaluation--Harris score [Time frame: 2-year postoperative]
• Aesthetic outcome evaluation--Ueda score [Time frame: 2-year postoperative]
• Local Recurrence-Free Survival(LRFS) [Time frame: 2-year postoperative and 5-year postoperative]
• Disease-Free Survival(DFS) [Time frame: 2-year postoperative and 5-year postoperative]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• West China Hospital, SiChuan University — Chengdu

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07237828 · 2025(440)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗