Indications for Laparoscopic Supracervical Hysterectomy
Conditions
Keywords
Supracervical Hysterectomy, Leiomyomas, Adenomyosis
Brief summary
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.
Interventions
DEVICESealing tissue with the Enseal device
PROCEDUREConventional supracervical hysterectomy
Sponsors
Ethicon Endo-Surgery (Europe) GmbH
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy) * Willingness and capability to comply with all study tests, procedures, and assessment tools * Capability of providing informed consent.
Exclusion criteria
* History of, or evidence of, gynecologic malignancy within the past five years * Pace maker, internal defibrilator/cardioconverter * Impaired coagulation parameters * Unwillingness to be randomized to treatment * History of median laparotomy * Intraabdominal adhesions * Requirement for open laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Day 2 | 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. |
| Post-operative pain | Day 2 | Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay. |
Countries
Germany
Outcome results
None listed