PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.

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Key information

Conditions

Adhesion Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pius Hospital Oldenburg, Oldenburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study.
Patients in whom ADEPT® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery.

Exclusion criteria

Patients who had frank infection in the abdominopelvic cavity at the time of the surgery.
Patients who were pregnant or nursing at the time of the surgery.

Treatment and study plan

ADEPT

Device

Adhesion Reduction Solution (4% icodextrin solution)

Primary outcomes

Incidence of hospital readmissions directly or possibly related to adhesions

Time frame: Within 2 years of surgery
Patient charts will be reviewed to collect data on readmissions related to adhesions, which are defined as:
- Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract);
- Possibly related to adhesions (gynecological operations, abdominal surgery, and non-operative readmissions);
- Open or laparoscopic reoperations that could potentially be complicated by present adhesions.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Post-Market Clinical Follow-up Study for ADEPT® in Laparoscopic Gynecologic Surgery

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Apr 13, 2023
Registry last updated: Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed