Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to breast reconstruction surgery called the DIEP flap, specifically looking at whether it’s safe and effective to avoid using surgical drains after the procedure. Surgical drains are typically used to remove excess fluid from the surgical site, but they can also lead to complications like infections and may make recovery more uncomfortable. In this trial, researchers will compare two groups of women: one that uses drains after the surgery and one that does not. They will look at how this choice affects complications, recovery time, and overall hospital stay.

To participate in the trial, women must be at least 18 years old and planning to have a DIEP flap procedure for breast reconstruction due to breast cancer. They should not have had previous open abdominal surgery and must be non-smokers for at least three months before surgery. Participants will be closely monitored for any issues during recovery and will help researchers understand if avoiding drains can lead to a quicker and safer recovery process. This trial aims to improve the experience for women undergoing this type of surgery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent must be obtained prior to any screening procedures
• • 2. Gender: female
• • 3. Age \>18 years old
• • 4. Breast cancer for which mastectomy is planned (primary case) OR patient has already had mastectomy (secondary case)
• • 5. Wish to have a DIEP flap procedure (uni-or bilateral) for breast reconstruction
• • 6. Meets criteria for DIEP flap procedure (no previous open abdominal surgery)
• • 7. Pre- and postoperative smoking cessation of 3 months
• Exclusion Criteria:
• • 1. Patient has history of open abdominal surgery wich compromises blood flow to DIEP flap
• • 2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
• • 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
• • 4. No informed consent
• • 5. Age \< 18 years old
• • 6. Currently smoking or cessation \<3 months preoperatively
• • 7. The use of immunosuppressive drugs
• • 8. Other ongoing therapies which might compromise normal postoperative course (e.g. chemotherapy, radiotherapy, ...)