Adhesion
Conditions
Keywords
gynecological surgery, adhesion related morbidities
Brief summary
The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients. Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.
Interventions
DEVICECoseal
Adhesion reduction
Sponsors
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study. 2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation
Exclusion criteria
1\. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery. | within 2 years of surgery | Patient charts will be reviewed to collect the 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 (gynecologic operations, abdominal surgery, and nonoperative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions |
Countries
Italy, United States
Outcome results
None listed