Clinical trial · Interventional
ERAS in Autologous Breast Reconstruction: A Pilot RCT
Enhanced Recovery After Surgery in Autologous Breast Reconstruction: A Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Over 26,000 Canadian women are diagnosed with breast cancer each year and 1 in 3 patients undergo mastectomy. With an upward of 40% of breast cancer patients seeking post-mastectomy breast reconstruction (PMBR), there is a significant opportunity to improve the quality of perioperative care for breast reconstruction patients. Enhanced Recovery After Surgery (ERAS) is a multidisciplinary, multimodal, and evidence-based approach to perioperative care that safely reduces hospital length of stay and opioid use following colorectal surgery. ERAS recommendations have been proposed for women undergoing autologous PMBR who typically stay in hospital 4 to 5 days after surgery. However, the evidence to support ERAS in breast reconstruction is limited to observational studies compared to the numerous clinical trials in colorectal surgery. The goal of this study is to address this knowledge gap by evaluating the feasibility of conducting a RCT comparing ERAS to standard perioperative care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS pathway | Other | — | UNRESOLVED |
| Standard Perioperative Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enhanced Recovery After Surgery (ERAS) pathway
- description
- Preop 1. Diet: Solids until midnight before surgery with a carbohydrate rich drink before midnight and 3-hours prior to surgery. 2. Analgesia: Acetaminophen 975mg \& Celecoxib 400mg administered PO 1-hour before surgery. Intraop 1. Hypothermia prevention: Forced-air warming units and core temperature monitoring. 2. Fluid management: Euvolemic fluid management with balanced crystalloid solution. 3. Analgesia: 0.25% bupivacaine block of intercostal nerves and rectus sheath by the surgical team. Additional IV analgesia by anesthesiologist with the goal to minimize opioids. 4. PONV prophylaxis: Ondansetron 4-8mg IV during emergence. Postop 1. Diet: Clear fluids immediately post-op. Saline lock and advance to DAT on POD#1. 2. Analgesia: Routine administration of Acetaminophen 975mg PO q6h \& Celecoxib 200mg PO q12h. Opioids used as breakthrough analgesia only. No PCA. 3. Early mobilization: Mobilization within the first 24 hours after surgery with assistance.
- interventionNames
- Other: ERAS pathway
- type
- ACTIVE_COMPARATOR
- label
- Standard Perioperative Care
- description
- Patients in the control arm received routine perioperative care as determined by respective surgeons participating in the study.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women of age 18 years or greater 2. Able to understand and communicate in English 3. Diagnosis of breast cancer or BRCA gene 4. Undergoing (or previously had) unilateral or bilateral mastectomy 5. Undergoing immediate or delayed DIEP breast reconstruction (unilateral or bilateral). Patients undergoing repeat breast reconstruction (secondary reconstruction) after a previously failed alloplastic or autologous reconstruction will be eligible to participate. Patients undergoing both DIEP and alloplastic reconstruction (e.g. DIEP reconstruction for one breast, alloplastic reconstruction for the other breast) will also be eligible to participate. Exclusion Criteria: 1. Non-ambulatory at baseline 2. Pregnant 3. Unable to provide informed consent or unable to complete quality of life questionnaires due to mental capacity, cognitive impairment, or language barrier.
References
Publications (0)
Data not yet available