PMCF Study for COSEAL® in Gynecologic Surgery

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Device: Coseal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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

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 |
| --- | --- |
| Patients who underwent an index gynecologic surgery<br>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 | Device: Coseal<br>* Adhesion reduction<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 following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index 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 | within 2 years of surgery | 

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