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NCT Number: NCT06071234

Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy

The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

About this study

The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knife separation,the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3D tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed diagnosis of breast cancer
  • Age: 18 to 70 years old
  • No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
  • Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;

Exclusion criteria

  • Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
  • Participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;

Treatment and study plan

3D reconstruction technology

Procedure

Preoperative application of 3D reconstruction technology to evaluate the breast blood supply of participants and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to surgery without preoperative evaluation.

Primary outcomes

  1. Ischemic complications of flap and nipple areola complex

    Time frame: 1 week and 2 week after surgery

    The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery

Secondary outcomes

  1. Severity of ischemic complications in the flap and nipple areola complex

    Time frame: 1 week and 2 week after surgery

    Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery

  2. Duration of surgery

    Time frame: postoperative

    Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.

  3. Blood loss

    Time frame: Preoperative and 2 hours postoperatively

    Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test

  4. Breast-Q Satisfaction

    Time frame: Preoperative, 3 months and 1 year postoperatively

    The outcome will be the score (continuous variable ranging from 0 to 100 for linear regression or ordinal categories, ranging from 1 to 4 for ordinallogistic regression, where 1 represents lowest satisfaction and 4 represents highest satisfaction), and the primary predictor of interest will be type of consultation provided.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

An Exploration of 3D Reconstruction Tool for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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