PMCF Study for COSEAL® in Gynecologic Surgery

Recruiting

• Conditions: Adhesion
• Interventions: Device: Coseal

• Registration Number: NCT05996809
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-18
• Study Start: 2024-02-23
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent an index gynecologic surgery	Coseal	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Universita Campus Bio Medico di Roma; 🇮🇹 Rome, Italy

Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States