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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient of a Laparoscopic Gynecologic Surgery | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADEPT | Device | Adhesion Reduction Solution (4% icodextrin solution) |
|
| 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:
| Within 2 years of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The population will consist of patients who underwent an index laparoscopic gynecologic surgery (performed at least 2 years prior to the start of the study) during which ADEPT (4% icodextrin solution) was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Fertility Center | Austin | Texas | 78731 | United States | ||
| Pius Hospital Oldenburg |
Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Upon approval of a legitimate research request.
Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oldenburg |
| Germany |