Health TrialsbyHealthPanel

The Comparison Between DEDTI BR and T/E BR

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWest China Hospital

About this trial

This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;

At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;

Voluntary provision of informed consent.

Disqualifiers

Local/regional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);

Pectoralis major muscle was resected during the initial surgery;

Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;

Immunodeficiency;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Delayed endoscopic direct-to-implant breast reconstruction

    Procedure/Surgery

    This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.

  • Two-stage expander-to-implant breast reconstruction

    Procedure/Surgery

    The two-stage expander-to-implant breast reconstruction involves initially placing a tissue expander to stretch the skin. Once the skin has sufficient capacity, a second surgery is performed to replace the expander with a breast implant. The expander can be gradually adjusted based on the patient's skin expansion progress, physical recovery, and aesthetic needs to achieve optimal reconstruction results.

Treatment groups

412 Participants
are divided into 2 treatment groups
Group A: DEDTI groupExperimental treatment 1 intervention
Group B: T/E groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgical complication rates

Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis.

Time frame
Postoperative 2 years

Secondary outcomes

1

Operation time

The surgical time includes total anesthesia time, total operative time, and flap dissociation time.

Time frame
Intraoperative
2

Number of operations

The number of surgical procedures performed, representing the total count of operations conducted.

Time frame
Intraoperative
3

Contralateral breast adjustment operation rates

The rate of contralateral breast adjustment operations, defined as the proportion of patients who undergo additional surgical procedures to modify or adjust the contralateral (opposite) breast to achieve symmetry with the reconstructed breast.

Time frame
Intraoperative
4

Surgery-related costs

Surgery-related costs include total hospitalization expenses, surgical costs, postoperative dressing change costs, expander injection costs, etc.

Time frame
Postoperative 1 month

Other outcomes

Sponsors and contacts

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

West China Hospital

Lead sponsor

West China Second University Hospital

Collaborator

Fourth People's Hospital of Sichuan Province

Collaborator

West China Fourth Hospital

Collaborator

The Second People's Hospital of Chengdu

Collaborator

Suzhou Municipal Hospital

Collaborator

Source ClinicalTrials.gov

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