Efficacy of local hemostatic material in ovarian endometriotic cyst surgery

JRCT ID: jRCTs032220355

Registered date:03/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: surgery
• Date of first enrollment: 10/02/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): After obtaining consent prior to surgery, the test drug is applied intraperitoneally to the site of bleeding during surgery.

Outcome(s)

Primary Outcome

1) Number of times of electrocoagulation during surgery
2) Cumulative time of electrocoagulation during surgery
The following items will be evaluated in the PureStat- and non-use groups, as well as by site of bleeding in all patients. The number of ovarian bleeding sites, the number of ovarian bleeding sites that stopped spontaneously without hemostatic treatment, the number of ovarian bleeding sites that required hemostatic treatment, and the number of bleeding sites and hemostatic sites for each side of the ovary will be counted. For each ovarian bleeding site, the number of times of electrocoagulation, cumulative time of electrocoagulation, amount of PureStat used, hemostatic method, and the nature of bleeding (arterial or venous) are evaluated.

Secondary Outcome

1) Postoperative change in serum AMH level (percentage decrease from preoperative value)
2) Peritoneal bleeding at the site of detachment of peri-ovarian adhesions associated with ovarian cyst removal: Count the number of bleeding sites, the number of sites where the bleeding stopped spontaneously without hemostatic treatment, and the number of peritoneal bleeding sites that required hemostatic treatment. For each site of peritoneal bleeding due to detachment of peri-ovarian adhesions associated with ovarian cyst removal, the number of times of electrocoagulation, cumulative time of electrocoagulation, amount of PureStat used, hemostatic method, and nature of bleeding (arterial or venous) will be evaluated.
3) Achievement rate of hemostasis with PureStat alone (number of bleeding sites hemostatic with PureStat alone/total number of bleeding sites)
4) Rebleeding rate after achieving hemostasis with PureStat alone (number of rebleeding sites/number of bleeding sites hemostatically stopped with PureStat alone)
5) Amount of PureStat used per case
6) Douglas fossa echo free space

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Female

Include criteria

1) Women between the ages of 20 and 40
2) Patients with unilateral or bilateral chocolate cysts diagnosed by MRI, ultrasound, or both.
3) Patients with at least one chocolate cyst with a diameter greater than 4 cm.
4) Patients with chocolate cysts not exceeding 10 cm in diameter on either bilateral ovaries
5) Patients for whom the decision to undergo laparoscopic ovarian cystectomy was made at a conference including at least 3 obstetricians/gynecologists.
6) Patients who are able to cooperate with condom contraception until the first postoperative month of outpatient visits or until the onset of the first postoperative menstrual period, whichever is longer.
7) Patients whose written consent to participate in this study has been obtained.

Exclude criteria

1) Patients suspected of having malignant or borderline malignant ovarian tumors
2) Pregnant patients
3) Patients with a history of hypersensitivity to peptide or protein preparations
4) Patients on dialysis
5) Patients with severe hepatic impairment
6) Patients with renal failure
7) Patients with obvious bleeding tendency
8) Patients who are otherwise deemed unsuitable for the study in the judgment of the physician.

Related Information

• Primary Sponsor: Iwase Akira
• Secondary Sponsor: 3-D Matrix, Inc