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Use of PEQ-I technique in Immediate Breast Reconstrution with Latissimus Dorsi Myocutaneous Flap Combined with Silicone Implant (P-BRELD trial)

Use of PEQ-I technique in Immediate Breast Reconstrution with Latissimus Dorsi Myocutaneous Flap Combined with Silicone Implant (P-BRELD trial): A Randomized Multicenter, Prospective, Three-arm controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031116
Enrollment
Unknown
Registered
2020-03-22
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

1:Traditional maneuver for Latissimus dorsi myocutaneous flap harvest
2:Quilting suture
3:PEQ-I

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Female breast cancer patient aged between 18 and 60 years; 2. Tumor stage T0-2N0-1M0; 3. Accept to undergo mastectomy and Latissimus dorsi myocutaneous flap combined with implant-based immediate breast reconstruction; 4. BMI ranging from 18 to 28 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Tumor stage: T>=3 or N>=2 or M>=1; 2. Women during pregnancy; 3. Women with mental disorder or drug abuse; 4. Women with unstable diabetes, hypertension, or cardio-cerebrovascular disease; 5. Smoking or with smoking history; 6. ASA score up to at least level 3; 7. Women with previous surgery on the axillary or on the back; 8. Other severe comorbidities that is not suitable to be enrolled.

Design outcomes

Primary

MeasureTime frame
complication rate of donor site;draining time of donor site;

Secondary

MeasureTime frame
inpatient time after surgery;draining volume of donor site;rate of flap necrosis;patient-reported outcomes;

Countries

China

Contacts

Public ContactJian Yin

Tianjin Medical University Cancer Institute and Hospital

healthyin2018@163.com+86 022-23340123-1171

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026