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

NCT06468488 | Not Yet Recruiting

• 1 other identifier: S68700
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Inserting surgical drains is an ancient approach used across different specialties because of its many advantages such as discharge of fluid accumulation, appraising and qualifying drain capacities, lowering infection percentages, and eliminating dead space. Most commonly, abdominal closed-suction drains are used following autologous breast reconstruction with a DIEP flap to prevent donor site complications such as seroma, hematoma, and wound dehiscence. Although abdominal drains are effective in impeding accumulation, they are a potential portal for infection, Furthermore, they restrict patient mobility, are cumbersome, require time-consuming care upon discharge, potentially increase inpatient stay and ultimately resulting in impaired health-care costs. In the context of an Enhanced Rapid Protocol (ERP), not placing abdominal drains would be a step forward. This involves using \"quilting sutures\" to close the dead space after flap prelevation. Quilting sutures are placed between the subcutaneous tissues of the abdominal flap and the underlying fascia of the rectus abdominis muscle and aim to minimizes the shearing forces and collapse the death space without the use of drains. Progressive tension sutures were first described in 2000, in a retrospective paper on cosmetic abdominoplasty patients. Since then, their procedure has been analysed and adapted by many authors and applied in perforator-based abdominal flaps for breast reconstruction. Despite the drainless approach is well known in the literature for cosmetic abdominoplasty procedures, prospective clinical investigations to encourage the drainless approach in DIEP flap reconstruction is lacking. Therefore we want to set up a prospective study to make a comparison between the outcomes succeeding donor site closure after DIEP flap harvesting with (AD) or without (W-AD) the use of abdominal drains and investigate whether there is a correlation between the use of drains and the length of hospital stay. Secondary outcomes involve the complication rate of seroma, hematoma, and dehiscence analysis of abdominal drain output and postoperative recovery, including pain and follow-up complications as described above.

Conditions

Breast Reconstruction

Keywords

Breast reconstruction; DIEP; Drainless

Outcome Measures

Primary Outcomes (1)

• Length of stay (LOS)

  Length of hospital stay (LOS) is the same or less in patients without abdominal drains versus patients with drains

  During admission to the hospital

Secondary Outcomes (3)

• Complication rate

  from enrollment until study completion, an average of 1 year

• Pain (VAS)

  from enrollment until study completion, an average of 1 year

• Patient satisfaction (Breast Q)

  from enrollment until study completion, an average of 1 year

Study Arms (2)

DIEP flap surgery with drains

ACTIVE COMPARATOR

Patients will undergo a breast reconstruction by a DIEP flap with drains.

Procedure: DIEP flap surgery with drains

DIEP flap surgery without drains

EXPERIMENTAL

Patients will undergo a breast reconstruction by a DIEP flap without drains.

Procedure: DIEP flap surgery without drain

Interventions

DIEP flap surgery without drain PROCEDURE

Patients will undergo a breast reconstruction with a DIEP flap without the placement of drains.

DIEP flap surgery without drains

DIEP flap surgery with drains PROCEDURE

Patients will undergo a breast reconstruction with a DIEP flap with the placement of drains.

DIEP flap surgery with drains

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained prior to any screening procedures
• Gender: female
• Age \>18 years old
• Breast cancer for which mastectomy is planned (primary case) OR patient has already had mastectomy (secondary case)
• Wish to have a DIEP flap procedure (uni-or bilateral) for breast reconstruction
• Meets criteria for DIEP flap procedure (no previous open abdominal surgery)
• Pre- and postoperative smoking cessation of 3 months

You may not qualify if:

• Patient has history of open abdominal surgery wich compromises blood flow to DIEP flap
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
• No informed consent
• Age \< 18 years old
• Currently smoking or cessation \<3 months preoperatively
• The use of immunosuppressive drugs
• Other ongoing therapies which might compromise normal postoperative course (e.g. chemotherapy, radiotherapy, …)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Uz Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Felix De Bruyn, Medical doctor

CONTACT

+32479931742; felixdebruyn@hotmail.com

Julie Paternoster, Medical doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor in plastic surgery

Model Details: Non blindend randomized controlled trial

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

BE (1)