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Completed

NCT Number: NCT01806012

Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

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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Key information

Conditions

Indications for Laparoscopic Supracervical Hysterectomy Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Urogenital Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Women' Clinic Tübingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sealing tissue with the Enseal device

Device

Conventional supracervical hysterectomy

Procedure

Primary outcomes

  1. Operation time

    Time frame: 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 outcomes

  1. Blood loss

    Time frame: 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.

  2. Post-operative pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Ethicon Endo-Surgery (Europe) GmbH

Registry information

Official study title

Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2013
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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