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Session: ePoster: Benign Abdominal 6 (Mon8)

EP604 - Dehydrated Human Amnion/Chorion Membrane (DHACM) to Protect Against Anastomotic Leaks in Patients Undergoing a Low Anterior Resection Without Protective Ostomy

Monday, May 12, 2025
8:27 AM – 8:32 AM PT
Location: Monitor 1, Sails Pavilion, Upper Level

    ePoster Presenter(s)

  • Bidhan Das, MD, FACS (he/him/his)

    Associate Professor of Surgery
    Southwest Surgical Associates, LLP
    Houston, Texas, United States

    All of the relevant financial relationships listed below have been mitigated.
    This individual has no financial relationships with ineligible companies.

    • Author(s)

  • DC

    Dennis Choat, MD, FACS, FASCRS

    Associate Professor of Surgery
    Piedmont Physicians Colon and Rectal Surgery of Fayetteville
    Fayetteville, Georgia, United States

    Disclosure information not submitted.

  • NJ

    Nezar Jrebi, MD, FACS, FASCRS

    Colorectal Surgeon
    North Texas Surgical Specialists
    Ft. Worth, Texas, United States

    Disclosure information not submitted.

  • MB

    Matthew Bardin, PharmD, BCPS

    Principal
    STC Clinical, LLC
    Tampa, Florida, United States

    Disclosure information not submitted.

All of the relevant financial relationships listed below have been mitigated.
Bidhan Das, MD, FACS: This individual has no financial relationships with ineligible companies.
Image or Table (Do Not add text here):

Purpose/Background: Cell-based therapy in tissue regeneration has been recently reported for anal fistula repair, but these regenerative techniques can apply to more morbid concerns. Anastomotic leaks (AL) are the most serious complications of colorectal (CR) surgery due to increased morbidity, mortality, and costs. In the US, the overall incidence of AL in CR surgery has been estimated to be 6%,(1,2) however this has been estimated to be 7%-9.5% in patients undergoing a LAR without a protective ostomy.(3-5) Therefore, risk mitigation of anastomotic leaks remains a priority in this high-risk group. DHACM allografts are FDA-regulated, commercially available, non-viable cellular allografts derived from donated human placentas.(6) This tissue is rich in cytokines and growth factors known to play critical roles in wound healing and tissue growth.(7) Animal models have demonstrated the benefits of placental tissue in anastomotic wound healing in terms of increased bursting pressures, neoangiogenesis, fibroblast activity, collagenization, and epithelialization, as well as regenerative immunomodulation.(8) While human data is limited, several reports indicate DHACM may help to significantly decrease the rate of AL in patients receiving multiple types of colonic resections.(9,10) The purpose of this study is to evaluate real-world outcomes in patients receiving DHACM as an anastomotic risk mitigator during a LAR.

Methods/Interventions: Chart review of consecutive adult patients who received DHACM directly applied to the colorectal anastomosis during a LAR without a protective ostomy between 01MAR2016 and 30JUN2023. The primary endpoint was the incidence of any AL (defined by reanastomosis, stent, colostomy, drainage, fluid collection, and/or abscess) from closure of the operation up to 90 days post-op. US based studies evaluating ALrates in patients having a LAR without a protective ostomy were used as a control.(3-5) Prior to data collection, the study was granted an IRB Exemption (WCG IRB).

Results/Outcomes: 147 patients received DHACM applied to the colorectal anastomosis during an LAR, Figure 1. Only one met the protocol-defined criteria of an AL (0.68%). This patient (49 y/o male with stage T2 rectal cancer) returned to the ED 3 days after discharge on post-op day 5 with a fever and abdominal pain. His clinical condition and radiologic tests were indicative of an AL and he was taken to surgery. At that time the anastomotic leak was confirmed as well as a pelvic abscess and evidence of bleeding at the anastomosis site. Of the cancer patients identified in this study, all had not yet undergone chemo- or radiation-therapy at the time of surgery. There were no deaths in the cohort.

Conclusion/Discussion: The current data highlights that with the addition of DHACM as a risk-mitigation strategy, a significant reduction in protocol-defined AL is observed compared to historical controls. This data is reflective of previous reports demonstrating low AL rates in patients receiving DHACM for colorectal anastomoses.(9,10) Larger multi-centered studies are warranted to confirm these findings and the overall applicability of DHACM in colorectal surgery.

1. Hammond. J Gastrointest Surg, 2014;1176.
2. Turrentine. J Am Coll Surg, 2015;195.
3. Kang. JAMA Surg, 2013;65.
4. Caulfield. JAMA Surg, 2013;177.
5. Hrebinko. Int J Colorectal Dis, 2024;39.
6. AMNIOFIX® Human Amniotic Membrane Allograft Instructions for Use.2022.
7. Koob. Int Wound J, 2013;493.
8. Uludag. Int J Colorectal Dis, 2009;809.
9. Ortega. J Am Coll Surg, 2017;e6.
10. Jrebi. Am J Gastroenterol, 2024.