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OpenTrials
Completed

NCT Number: NCT02059954

Vaginal vs. Laparoscopic Hysterectomy

Hysterectomy for benign indication is one of the most common surgical procedures in women. Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but the proportion of laparoscopic (and robotic) hysterectomies is increasing.

This study will compare a range of clinical and subjective outcomes of vaginal vs. total laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to work as well as cosmesis, quality of life and sexual health.

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Key information

Conditions

Uterine Fibroids Abnormal Uterine Bleeding, Unspecified Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Metrorrhagia Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases Urogenital Diseases Uterine Diseases Uterine Hemorrhage Uterine Leiomyoma

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus der Barmherzigen Brüder, Abteilung Gynäkologie, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • benign indication for vaginal hysterectomy (e.g., abnormal uterine bleeding, fibroids, atypical endometrial hyperplasia)
  • clinical exam indicates vaginal hysterectomy is feasible
  • no major concomitant surgery
  • able to complete questionnaires in German

Exclusion criteria

  • uterine malignancy
  • major concomitant surgery (e.g., for incontinence or prolapse)
  • clinical exam indicating vaginal hysterectomy not feasible
  • contraindication for surgery or laparoscopy

Treatment and study plan

Hysterectomy

Procedure

Primary outcomes

  1. Operating time (min.)

    Time frame: Surgery

    Operating time (min.)

Secondary outcomes

  1. Complications

    Time frame: 6 weeks

    Intraoperative and postoperative complications

  2. Anesthesia time (min.)

    Time frame: surgery

  3. Quality of life

    Time frame: 12 months

  4. Sexual health

    Time frame: 12 months

  5. Return to work

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Austrian Urogynecology Working Group (AUWG)

Registry information

Official study title

Vaginal Hysterectomy Versus Total Laparoscopic Hysterectomy for Benign Indications: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 11, 2014
Registry last updated
Apr 17, 2018

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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