Clinical trial NCT04643106: Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
Official title: A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Ovarian Cyst
Keywords: endometriosis
endometrioma
ovarian cystectomy
ovarian function
ovarian reserve
hemostatic agent
suture
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

Detailed description: In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Eligibility criteria: Inclusion Criteria:

* Informed consent.
* Age: 19-45 year-old women
* American Society of Anesthesiologists Physical Status classification 1 or 2
* Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
* Regular menstruation every 21-45 days

Exclusion Criteria:

* No 'ovarian' endometriosis
* Suspicious disease of ovarian malignancy
* Age: 18 and younger, 46 and older
* Pregnancy or breastfeeding.
* Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
* Hormonal therapy within recent 3 months
* Considered as inappropriate by the researcher's judgment.

Primary outcomes:
measure: Ovarian function preservation 12 weeks after surgery
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Ovarian function preservation 48 weeks after surgery
timeFrame: 48 weeks after surgery
measure: The time required to finish hemostasis
timeFrame: during operation
measure: the success rate of hemostasis within 10 minutes
timeFrame: during operation
measure: Blood loss during operation
timeFrame: during operation
measure: Hemoglobin
timeFrame: post-op 2 days, 12 weeks and 48 weeks
measure: Transfusion during admission
timeFrame: post-op 2 days
measure: Adverse events associated with operation, bleeding or transfusion
timeFrame: post-op 2 days
measure: Hospitalization period
timeFrame: within post-op 2 weeks
measure: Operation running time
timeFrame: during operation
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee seung Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim H, Park SJ, Paik H, Mun J, Lee EJ, Lee S, Lim W, Song G, Shim SH, Lee CH, Yim GW, Kim HS; PRAHA Study Group. Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial). Trials. 2021 Jul 21;22(1):473. doi: 10.1186/s13063-021-05431-1.