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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemostatic agent group | Experimental | During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding. |
|
| Suturing group | Active Comparator | During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy | Procedure | During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®) |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function preservation 12 weeks after surgery | Reduction rate of AMH level in serum 12 weeks after surgery | 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function preservation 48 weeks after surgery | Reduction rate of AMH level in serum 48 weeks after surgery | 48 weeks after surgery |
| The time required to finish hemostasis | Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyunji Lim, MD | Contact | 82-2-2072-2821 | hyunji3292@gmail.com | |
| Hee seung Kim, MD/PhD | Contact | 82-2-2072-4863 | bboddi0311@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee seung Kim, MD/PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Ilsan Hospital | Not yet recruiting | Goyang-si | Gyeonggi-do | 10326 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34289889 | Derived | 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. |
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| suturing with barbed sutures during laparoscopic ovarian cystectomy | Procedure | During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding |
|
| during operation |
| the success rate of hemostasis within 10 minutes | Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes | during operation |
| Blood loss during operation | The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle | during operation |
| Hemoglobin | Change of serum hemoglobin from baseline | post-op 2 days, 12 weeks and 48 weeks |
| Transfusion during admission | whether patients are transfused during admission period | post-op 2 days |
| Adverse events associated with operation, bleeding or transfusion | any adverse events during admission period | post-op 2 days |
| Hospitalization period | days from admission day to discharge day | within post-op 2 weeks |
| Operation running time | time from anesthesia start to delivery of patient to recovery room | during operation |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D006487 | Hemostasis |
| D013537 | Sutures |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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