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| Name | Class |
|---|---|
| Ethicon Endo-Surgery (Europe) GmbH | INDUSTRY |
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The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enseal | Experimental | Tissue sealing with Enseal device |
|
| Supracervical hysterectomy using conventional instruments | Active Comparator | Supracervical hysterectomy using conventional instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sealing tissue with the Enseal device | Device |
| ||
| Conventional supracervical hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | The perioperative blood loss (ΔHb) was calculated using the comparison of the preoperative red blood cells (RBC) versus the RBC on the first post-operative day. The intraoperative blood loss was measured by the suction unit (categories: < 50 ml, 50 - 100 ml, > 100 ml) and by the number of applied blood transfusions. | Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Women' Clinic Tübingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23791399 | Derived | Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20. | |
| 23670744 | Derived |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Procedure |
|
| Post-operative pain |
Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay. |
| Day 2 |
| Rothmund R, Szyrach M, Reda A, Enderle MD, Neugebauer A, Taran FA, Brucker S, Hausch A, Wallwiener C, Kraemer B. A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy. Surg Endosc. 2013 Oct;27(10):3852-9. doi: 10.1007/s00464-013-2994-4. Epub 2013 May 14. |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |