Trial document




This trial has been registered retrospectively.
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  DRKS00009356

Trial Description

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Title

Laparoscopically assisted vaginal hysterectomy (LAVH) versus vaginal hysterectomy (VH) -
a prospective, randomized, double-blind study in patients with an indication for vaginal hysterectomy

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Trial Acronym

LAVA

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URL of the Trial

http:///

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Brief Summary in Lay Language

For the removal of the uterus, there are three different methods:
1. the removal of the uterus through an abdominal incision
2. the removal of the uterus through the vagina
3. a combination of both.

Distance by abdominal incision is used today only rarely. Whether the removal through the vagina or the combination of both with respect to postoperative pain, mobility and complications is beneficial, could not yet be clarified.
It is applied no new operational method, but two standard methods are compared.
When a group of patients in addition the inner lining of the abdominal cavity (peritoneum) is closed and left open at the other. So far, the decision has always been left to the surgeon. This study should be checked whether the leaving open leads to less pain after the obesity surgery.

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Brief Summary in Scientific Language

Hysterectomy is the most common surgical procedure for the treatment of dysfunctional bleeding with uterine leiomyoma and adenomyosis, with prolapse of the uterus and carcinomas. There are three methods to choose from: the abdominal hysterectomy (AH), vaginal hysterectomy (VH) and since 1989 also the laparoscopically assisted vaginal hysterectomy (LH) .All show work that the operation duration of LH compared to the VH is longer and complication rates and the loss of blood are comparable.
This study is designed as a multicenter study. The test facility is prospective, randomized, double-blind and has the objective to compare the postoperative pain and postoperative mobility after laparoscopically assisted vaginal hysterectomy with vaginal hysterectomy. It will be shown that the pain reliever consumption is similar in both treatment arms and are tested as successor hypothesis that the closing of peritoneum reinforces the pain stimulus. As a secondary objective of the study mobility is evaluated. The postoperative pain has been examined in only three studies. The statements are, however, contradictory.
The LAVA study should provide clarification regarding the recent conflicting results.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009356
  •   2015/10/14
  •   [---]*
  •   yes
  •   Approved
  •   56/07, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1174-1607 
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Health Condition or Problem studied

  •   N94 -  Pain and other conditions associated with female genital organs and menstrual cycle
  •   OPS-2015 5-683.02 (Laparoscopic assisted vaginal hysterectomy)
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Interventions/Observational Groups

  •   LAVH (laparoscopically assisted vaginal hysterectomy) arm:
    1. Postoperative to discharge from hospital, the pain intensity using the Visual Analog Scale (VAS) is a day of pain medication and am documenting. In addition, completed a mobility questionnaire daily both by the patient and by a blinded observer (not behandlender doctor's clinic, nurse or physiotherapist).
    2. In discharge the discharge questionnaire will be filled out. The following data are recorded: surgical technique with additional operational steps (eg Adnexexstirpation, colporrhaphy anterior and posterior, adhesiolysis, endometriosis stove destruction), duration of surgery, histology with uterine weight and additional findings, complications with the time of occurrence, hemoglobin pre-, postoperatively and at discharge, pain VAS and mobility score.
    3. Repeat after 6 weeks, six months and one year postoperatively by the patient.
  •   VH (Vaginal Hysterectomy)-arm:
    1. Postoperative to discharge from hospital, the pain intensity using the Visual Analog Scale (VAS) is a day of pain medication and am documenting. In addition, completed a mobility questionnaire daily both by the patient and by a blinded observer (not behandlender doctor's clinic, nurse or physiotherapist).
    2. In discharge the discharge questionnaire will be filled out. The following data are recorded: surgical technique with additional operational steps (eg Adnexexstirpation, colporrhaphy anterior and posterior, adhesiolysis, endometriosis stove destruction), duration of surgery, histology with uterine weight and additional findings, complications with the time of occurrence, hemoglobin pre-, postoperatively and at discharge, pain VAS and mobility score.
    3. Repeat after 6 weeks, six months and one year postoperatively by the patient.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

postoperative pain with and without open peritoneum

Postoperatively to discharge the pain medication consumption and morning, noon and evening pain intensity will be daily documented using the Visual Analog Scale.

This will be performed 6 weeks, six months and one year postoperatively by the patient.

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Secondary Outcome

postoperative mobility
- Daily survey of both the patient as well as by a blinded observer (not attending physician of the clinic, nurse or physiotherapist) with a mobility questionnaire

This will be performed 6 weeks, six months and one year postoperatively by the patient.

Additional Safety parameters:
intraoperative blood loss and the type and frequency of complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2007/08/28
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• removal of the uterus possible via the vaginal route
• circulatory disorders (hypermenorrhea, dysmenorrhea)
• Uterine fibroids
• adenomyosis
• uterine descent et vaginae with and without voiding dysfunction
• cervical cancer stage pT1a1
• Age> 18 years

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Exclusion Criteria

lack of study consent
• indication for vaginal hysterectomy after Sacrocolpopexy
• indication for lateral repair in lateral defect
• Malignancies with the indication for abdominal procedure
• Pre-existing conditions (internal medicine / orthopedic / anestesiologic) contraindicate the laparoscopic approach
• with continuous motion opioids in the last 12 months more than 2 weeks
• Metamizol- / Dipidolorallergie
• severe mental / neurological disorders
• alcohol, drugs, drug for pain-missuse
• polyneuropathy
• Immunosuppressive therapy
• participating in other studies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik
    • Mr.  Prof. Dr.med.  Serban-Dan  Costa 
    • Gerhart-Hauptmann-Straße 35
    • 39108  Magdeburg
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  OA Dr. med.  Holm  Eggeman 
    • Gerhart-Hauptmann-Straße 35
    • 39108  Magdeburg
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  OA Dr. med.  Holm  Eggemann 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsfrauenklinik
    • Mr.  Prof. Dr. med.  Serban-Dan  Costa 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/09/13
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.