What is Adept Adhesion Reduction Solution?

What is Adept Adhesion Reduction Solution?

Post-surgical adhesions, bands of connective tissue that join two normally separate anatomical structures, are one of the most common sequelae of gynecological surgeries, leading to chronic pain, infertility or bowel obstruction.¹ The extent of the problem of adhesions has been underestimated by surgeons and the health authorities, but there is rising evidence that surgeons can take important steps to reduce the impact of adhesions.¹ Among them, Adept Adhesion Reduction Solution is a broad coverage adhesion reduction agent that is designed for application during laparoscopic procedures as an adjunct to good surgical technique.²

This article will provide an overview of Adept Adhesion Reduction Solution, a 4% icodextrin solution, by exploring its mechanism of action, key clinical findings, and providing guidance on use. Whether you're already familiar with this adhesion barrier or hearing about it for the first time, Mona Orady, MD, Past President of the Society of Laparoscopic and Robotic Surgery and Director of Robotic Surgery at St. Francis Memorial Hospital*, will outline the crucial role it plays in minimally invasive gynecologic surgery.

Introduction

The formation and reformation of post-surgical adhesions lead to significant patient morbidity such as small bowel obstruction, infertility, chronic pain, and difficult, complicated subsequent surgeries.^3-5   Pre-existing adhesions significantly prolong the duration of surgery and lead to considerable complications in an important percentage of patients.⁶ Pelvic adhesions are the most common cause of infertility and chronic pelvic pain.⁷

Various strategies have been put forth to prevent adhesion development including meticulous surgical techniques, pharmacological agents and new equipment and instrumentation.⁴  Adept Adhesion Reduction Solution is a 4% icodextrin  solution that acts as a hydroflotation fluid reservoir that effectively separates damaged peritoneal surfaces providing a barrier to adhesion formation.^2,8

What is ADEPT Adhesion Reduction Solution? 

Adept Adhesion Reduction Solution received approval from the United States (US) Food and Drug Administration (FDA) in 2006 and is available in North America and worldwide.^8,9 It is a single use, sterile, clear, colorless-to-pale yellow fluid for intraperitoneal administration containing icodextrin at a concentration of 4% w/v in an electrolyte solution.⁸ Icodextrin is a cornstarch-derived, water-soluble branched glucose polymer.⁸  Adept solution is packaged in flexible polyvinylchloride bags containing 1 L or 1.5 L of solution.⁸ 

Selected Risk Information for Adept solution: Do not use in patients with known or suspected allergy to cornstarch-based polymers e.g. icodextrin, or with maltose or isomaltose intolerance or with glycogen storage disease.⁸ 

What is the Indication? 

Adept Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.⁸  

How Does It Work?   

The use of fluids in the peritoneal cavity to separate damaged peritoneal surfaces and prevent contact between organs during the time of postoperative repair has been proposed as a method of adhesion reduction—a process known as hydroflotation.² Icodextrin, as an alpha (14) linked glucose polymer, is similar in structure to carbohydrates which occur physiologically, e.g. glycogen.⁸ When administered intraperitoneally as a 4% solution, icodextrin functions as a colloid osmotic agent. This colloidal osmotic action of icodextrin allows the retention of a reservoir of fluid within the peritoneal cavity for 3-4 days.⁸ 

During laparoscopic gynecological surgery, Adept solution may be used as an irrigant solution during the course of surgery.⁸ Once the surgical procedure is completed, and the cavity is aspirated of all remaining fluid, a final volume of 1 liter of Adept solution is then introduced into the cavity before removal of the scope.⁸ 

Adept solution is believed to perform its function through a physical effect by providing a temporary separation of peritoneal surfaces by hydroflotation as a result of maintaining a fluid reservoir.⁸ This minimizes tissue apposition during the critical period of fibrin formation and mesothelial regeneration following surgery, thereby providing a barrier to adhesion formation.⁸ 

The peritoneal surface takes several days to recover after surgery, so solutions with a short residence time would not be expected to prevent adhesion formation.² This is supported by the results of a meta-analysis of 22 published reports, which showed that the use of crystalloid instillates in volumes of up to 500 mL did not increase adhesion-free outcome in patients undergoing abdominopelvic surgery.¹⁰ 

Marked differences in intraperitoneal residence times between icodextrin (which is absorbed slowly over a period of several days) and crystalloid solutions (which remain in the cavity for approximately 24 hours) support the idea that prolonged hydroflotation helps to keep peritoneal surfaces apart during the key stages of wound repair, thus reducing the likelihood of adhesion formation.³

Clinical Evidence: Pivotal Study   

In the pivotal study for Adept Adhesion Reduction Solution known as PAMELA (Pivotal, Double-Blind, Comparative, Multicenter Study to Determine the Efficacy and Safety of ADEPT Adhesion Reduction Solution in Reduction of Post Surgical Adhesions after Laparoscopic Surgery), the object was to evaluate the safety and efficacy in reducing adhesions after laparoscopic gynecologic surgery involving adhesiolysis as compared to lactated Ringer’s solution (LRS).² The methodology involved initial adhesion scoring and follow-up laparoscopy 4–8 weeks later, assessing the presence, extent, and severity of adhesions, with clinical success defined as a reduction in adhesions of at least 3 or 30% of sites lysed.²  

Results demonstrated a significant reduction in adhesion formation with Adept Adhesion Reduction Solution as compared to LRS, with 49% of the Adept solution patient achieving clinical success versus 38% in the LRS group (Figure 2).² Safety profiles were similar between both groups, indicating Adept solution is an effective and safe option for reducing adhesions following gynecologic laparoscopic adhesiolysis.²  

Clinical Evidence: ARIEL Patient Registry  

The ARIEL (ADEPT Registry for Clinical Evaluation) Registry was established in 2000 to provide systematic feedback on the use of Adept Adhesion Reduction Solution in routine gynecological surgery.¹¹ Gynecological surgeons from 150 centers recorded patient demographics, use of Adept Adhesion Reduction Solution and adverse events, and made subjective assessments of ease of use and patient acceptability with the agent.¹¹  The gynecological surgery registry included 2,882 patients; 72% (n=2,069) underwent laparoscopies.

Most surgeons rated the ease of use (viewing of surgical field and handling of tissues) as ‘excellent’ or ‘good’.¹¹ The incidence of adverse events reflected expected rates in gynecological surgery.¹¹ ARIEL data indicate that Adept Adhesion Reduction Solution was well tolerated and easy to use for the reduction of adhesion formation following gynecological surgery.¹¹

In summary, Adept Adhesion Reduction Solution represents an important advancement in the reduction of post-surgical adhesions, a common complication in abdominopelvic surgeries.¹ Composed of icodextrin 4% solution, Adept Adhesion Reduction Solution Barrier prevents contact between organs during the time of postoperative repair in a process known as hydroflotation.²

Clinical evidence has demonstrated the effectiveness of Adept Adhesion Reduction Solution in reducing post-surgical adhesions following minimally invasive gynecological surgery that involves adhesion release.² A key aspect of Adept solution is its ease of use which most surgeons rated as ‘excellent’ or ‘good’.¹¹ In addition, it is the only fluid-based solution for gynecological adhesion reduction approved by the US FDA.² By offering a reliable option to a longstanding challenge in surgery, Adept Adhesion Reduction Solution supports patient recovery and exemplifies the progress in surgical adhesion reduction.⁸

*Dr. Mona Orady was compensated for her time developing this blog.