Laparoscopic Hysterectomy Clinical Trial
Official title:
Surgicel Snow in Gynecological Surgery
Verified date | July 2021 |
Source | Danbury Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgicel Snow is an FDA approved topical hemostatic agent for use during surgical procedures. Like the other mechanical agents, Surgicel Snow forms a physical barrier that blocks blood flow while providing a large surface area for the rapid formation of a fibrin clot. As a mechanical agent derived from oxidized regenerated cellulose, Surgicel Snow shares with other mechanical hemostatic agents, the benefits of a favorable risk profile. This study would examine the efficacy of Surgicel Snow vs. direct compression in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective in patients undergoing laparoscopic or robotic assisted laparoscopic hysterectomy. The intraoperative inclusion bleeding characteristics are minimal and mild retroperitoneal bleeding and moderate retroperitoneal bleeding that has been adequately reduced by standard surgical methods. 60 patients will be recruited for this study, all of which will be scheduled for hysterectomy at Western Connecticut Health Network (Norwalk Hospital and Danbury Hospital) under the direction of Dr. Thomas Rutherford, Dr. John Garofalo, and Dr. Robert Samuelson. The investigators will randomize 30 patients to the treatment group and 30 patients to the control group. Participants may continue all regular medications before and during the study. The consent process will be incorporated into the last pre-operative office visit. The health risks associated with use of Surgicel Snow may be less, the same or more than direct pressure alone. Surgicel Snow is generally used for minimal to mild bleeding from specific or widespread area; however, its effectiveness compared to direct pressure is unknown for a hysterectomy surgery.
Status | Completed |
Enrollment | 43 |
Est. completion date | February 11, 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. Women =18 years of age 2. Women scheduled for standard multiport laparoscopic, single site laparoscopic, and robotic assisted laparoscopic hysterectomy. 3. Sites of surgery include Norwalk Hospital and Danbury Hospital. 4. Indication for surgery includes benign, complex benign, and malignant conditions. 5. Signed informed consent Exclusion criteria: 1. Vaginal hysterectomy or open abdominal hysterectomy; 2. Congenital or acquired coagulation disorder including recent (within 7 days of surgery) therapeutic anticoagulation or use agents affecting platelet function, other than low dose aspirin. (Preoperative prophylactic heparin is not an exclusion criterion.) 3. Hysterectomy at the time of sacrocolpopexy. 4. Ovarian cancer |
Country | Name | City | State |
---|---|---|---|
United States | Danbury Hospital | Danbury | Connecticut |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | Physicians for Women's Health | Norwalk | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Danbury Hospital | Ethicon, Inc. |
United States,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bleeding at Specified Time Intervals | Because multiple factors other than retroperitoneal bleeding contribute to the total intraoperative bleed loss, the investigators believe that the intraoperative estimated blood loss is not a pure indicator of the efficacy of a topical hemostatic agent for control of retroperitoneal bleeding. Data from the specified time points (4 minutes, 7 minutes and 10 minutes) was combined to calculate an average bleeding event time for each subject. | 4 minutes, 7 minutes and 10 minutes | |
Secondary | Total Intraoperative Time | Total intraoperative was collected from medical record. | up to 4 hours | |
Secondary | Rate of Intraoperative Blood Loss | Intraoperative blood loss data was collected from medical record. | up to 4 hours | |
Secondary | Blood Transfusion | Blood transfusion details was collected from medical record. | up to 4 hours | |
Secondary | Total Postoperative Symptomatic Fluid Collection | Postoperative symptomatic fluid collection data collected at 2 week and 6 week time period was obtained from medical record. Data from 2 week and 6 week time points was combined to calculate the total postoperative symptomatic fluid collection for each subject. | through study completion, an average of 6 weeks | |
Secondary | Number of Participants With Postoperative Pelvic Abscess | Postoperative pelvic abscess data was collected from medical record. | through study completion, an average of 6 weeks |
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