An interventional study of Bipolar coagulation and Coagulation by FLOSEAL haemostatic agent in Benign Ovarian Cyst and Cystectomy, sponsored by University Hospital, Montpellier. Not yet recruiting at 2 sites in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Health services research
Introduction : The most common technique used for ovarian cystectomy is the stripping technique. After stripping the cyst wall, the subsequent bleeding of the ovarian stromal wound is usually controlled by bipolar coagulation or/and by suturing. However, hemostasis achieved with bipolar coagulation could result in damage to the ovarian reserve. To avoid damage to healthy ovarian tissue, hemostasis using various topical hemostatic agents has been introduced to control post- cystectomy ovarian wound bleeding. Among these, FloSeal (Baxter Healthcare Corporation, Deer- field, IL, USA) is a hemostatic sealant composed of a gelatin-based matrix and thrombin solution.
Aim: The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Müllerian hormone (AMH).
Methods: A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions (n = 80), Montpellier University Hospital and Nimes University Hospital, France. Patients were randomly divided into two groups treated with either a topical hemostatic sealant (Floseal) or bipolar coagulation for hemostasis. Preoperative, 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared.
73 studies on the registry are indexed under Ovarian Cysts; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 48 interventional studies indexed under Ovarian Cysts.
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Exclusion Criteria:
The bipolar forceps allow electrocoagulation and are part of the standard laparoscopy box, delivered by the sterilization service to the gynecology operating room.
Procedure: Bipolar coagulation
FLOSEAL® is a hemostatic agent based on gelatin of bovine origin added to thrombin of human origin. It is a recommended medical device in surgical procedures as an adjunct to hemostasis when control of bleeding, arterial jet seepage, ligation or any other conventional method proves impractical or ineffective. During this study, it will be used in 1st intention.
Procedure: Coagulation by FLOSEAL haemostatic agent
Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps. Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by bipolar coagulation. Then, the remnant tissue will be examined using irrigation and coagulated with minimal bipolar power (20-W current) on any sites that are bleeding.
Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps. Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by either hemostatic sealants (FloSeal). Using a laparoscopic applicator, FloSeal will be applied to the surface of bleeding sites under direct vision and the ovarian cortex was gently pressed for 2 min with small gauze.
Serum anti-Mullerian hormone (AMH) level preoperative
A biological assessment with determination of the serum AMH level will be carried out for each patient during the preoperative consultation.
Time frame: Between 2 and 17 days before cystectomy
Serum anti-Mullerian hormone (AMH) level at 3 months
A biological assessment with determination of the serum AMH level will be carried out for each patient, 3 months postoperatively.
Time frame: 3 months after the cystectomy
Serum anti-Mullerian hormone (AMH) level at 6 months
A biological assessment with determination of the serum AMH level will be carried out for each patient, 6 months postoperatively.
Time frame: 6 months after the cystectomy
Time to achieve hemostasis
The time is measured in minutes from the end of the cystectomy to the end of hemostasis.
Time frame: From the end of the cystectomy to the end of hemostasis (up to 1 hour)
Use of additional hemostatsis technique
Another technique can be used to achieve hemostasis: bipolar forceps, suture or second hemostasis agent. The other technique will be specified if it is used
Time frame: From the end of the cystectomy to the end of hemostasis, during surgery
Blood loss
Blood loss will be measured in ml throughout the surgery.
Time frame: From the start of the surgery to the end of hemostasis
Intraoperative adverse effects
Adverse effects related to the coagulation procedure will be collected.
Time frame: From the end of the cystectomy to the end of hemostasis
Revision surgery for bleeding at the operative site
In the event of bleeding at the operative site, revision surgery may be necessary. In this case the information will be collected.
Time frame: From the end of the cystectomy to the end of hemostasis
Plan to share: No
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier