Breast CancerDRAINNCT07237828
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
A study testing Drain Removal Timing After Endoscopic Breast Reconstruction Surgery in people with Breast Cancer, run by Du Zhenggui at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, SiChuan University
Chengdu, Sichuan, 610041
Zhenggui Du, Dr, +86 13880768222, docduzg@163.com
Tianyuan Li, +86 15510183188, Lity0526@163.com
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Keywords
- Breast Cancer, Minimal invasive surgery, Nipple-sparing mastectomy, Endoscopic surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drain Removal Timing After Endoscopic Breast Reconstruction SurgeryProcedure or surgery
The optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Remove drainage tubes on postoperative day 5 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative (baseline), 3-month postoperative
Secondary outcomes (13)
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
Measured: Perioperative
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.
Measured: 14 days postoperative and 3 months postoperative
wound care
The differences in the number of dressing changes and wound care procedures.
Measured: 3 months postoperative
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
Measured: 3 months, 1 year and 2 years postoperative
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
Measured: 2 years postoperative
Quality of Life--BREAST-Q scores
The Psychosocial Well-Being, Sexual Well-Being, and Physical Well-Being of the Chest modules of BREAST-Q questionnaire are used to evaluate quality of life (QoL) outcomes. Transformed scores range from 0 to 100, with higher values indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be recorded, along with pre- to postoperative differences in transformed scores
Measured: Preoperative (baseline), 3 months and 2 years postoperative
Surgical margin involvement
Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination
Measured: 2-3 weeks postoperative after paraffin-embedded pathological report available
The total volume of drainage
The volume of drainage refers to the total amount of fluid drained from the time of tube placement to the time of tube removal, measured in milliliters.
Measured: Perioperative
Aesthetic outcome evaluation--Harris score
The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).
Measured: 2-year postoperative
Aesthetic outcome evaluation--Ueda score
Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented
Measured: 2-year postoperative
Local Recurrence-Free Survival(LRFS)
The time interval from initiation of treatment to the first recurrence at the primary tumor site.If local recurrence appears, record the time and location of recurrence
Measured: 2-year postoperative and 5-year postoperative
Disease-Free Survival(DFS)
The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location.
Measured: 2-year postoperative and 5-year postoperative
Overall Survival(OS)
The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason.
Measured: 2-year postoperative and 5-year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Zhenggui
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, West China Fourth Hospital, Bethune Hospital of Shanxi Medical University, The First Hospital of Jilin University, Shanxi Province Cancer Hospital, Suining Central Hospital, The Second Affiliated Hospital of Kunming Medical University, Zhengzhou Central Hospital, Deyang People's Hospital, Suzhou Municipal Hospital, Chengdu Fifth People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Fourth People's Hospital of Sichuan Province, China-Japan Union Hospital, Jilin University, Guangzhou First People's Hospital, Xinjiang Medical University Affiliated Cancer Hospital, Fujian Medical University Union Hospital, Central Hospital of Taiyuan, West China Tianfu Hospital
- Responsible party
- Sponsor-investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237828
- Sponsor's protocol ID
- 2025(440)
- Acronym
- DRAIN
- Status last verified
- May 2025
- First submitted
- 20 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
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.
PubMed 37991082Zhou 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.
PubMed 38348883Yang 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.
PubMed 37422354Zhang 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.
PubMed 34424367Jia-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.
PubMed 26313786Sung 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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07237828
- Acronym / sponsor ID
- DRAIN / 2025(440)
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Minimal invasive surgery, Nipple-sparing mastectomy, Endoscopic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 379 participants (estimated)
- Lead sponsor
- Du ZhengguiUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, West China Fourth Hospital, Bethune Hospital of Shanxi Medical University, The First Hospital of Jilin University, Shanxi Province Cancer Hospital, Suining Central Hospital, The Second Affiliated Hospital of Kunming Medical University, Zhengzhou Central Hospital, Deyang People's Hospital, Suzhou Municipal Hospital, Chengdu Fifth People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Fourth People's Hospital of Sichuan Province, China-Japan Union Hospital, Jilin University, Guangzhou First People's Hospital, Xinjiang Medical University Affiliated Cancer Hospital, Fujian Medical University Union Hospital, Central Hospital of Taiyuan, West China Tianfu Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 20 Nov 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Drain Removal Timing After Endoscopic Breast Reconstruction SurgeryRemove drainage tubes on postoperative day 5 |
| Control group | No intervention | –Remove drainage tubes when the daily drainage volume is less than 30 ml/day for two consecutive days after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| Drain Removal Timing After Endoscopic Breast Reconstruction SurgeryThe optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery. | Procedure or surgery | Intervention group |
Primary outcome
Aesthetic outcome evaluation--BREAST-Q scores
Time frame: Preoperative (baseline), 3-month postoperative
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
13 secondary outcomes
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
Overall Survival(OS)
Time frame: 2-year postoperative and 5-year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 37991082Feng 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.
- Background: PubMed 38348883Zhou 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.
- Background: PubMed 37422354Yang 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.
- Background: PubMed 34424367Zhang 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.
- Background: PubMed 26313786Jia-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.
- Background: PubMed 33538338Sung 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.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain Removal Timing After Endoscopic Breast Reconstruction Surgery in people with Breast Cancer, run by Du Zhenggui at 1 site in China.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Nov 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenggui Du, Dr (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic outcome evaluation--BREAST-Q scores (time frame: Preoperative (baseline), 3-month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237828, which also lists 6 linked publications.
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 20 Nov 2025.