PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Adhesion

Intervention / Treatment
-----------------
* Device: ADEPT


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient of a Laparoscopic Gynecologic Surgery<br>ADEPT administered intraperitoneally as a liquid, used for irrigation throughout the procedure and for final instillation of a suitable amount at the end of the procedure. | Device: ADEPT<br>* Adhesion Reduction Solution (4% icodextrin solution)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital readmissions directly or possibly related to adhesions | 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. | Within 2 years of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic gynecologic surgery, adhesion-related morbidities