Trial document
This trial has been registered retrospectively.
DRKS00009356
Trial Description
Title
Laparoscopically assisted vaginal hysterectomy (LAVH) versus vaginal hysterectomy (VH) -
a prospective, randomized, double-blind study in patients with an indication for vaginal hysterectomy
Trial Acronym
LAVA
URL of the Trial
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.
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.
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
Secondary IDs
- U1111-1174-1607
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)
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.
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- patient/subject, assessor
- Active control (effective treament of control group)
- Other
- Parallel
- N/A
- N/A
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.
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2007/08/28
- 200
- Multicenter trial
- National
Inclusion Criteria
- Female
- 18 Years
- no maximum age
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsfrauenklinik
- Mr. Prof. Dr.med. Serban-Dan Costa
- Gerhart-Hauptmann-Straße 35
- 39108 Magdeburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49-391-67-17301
- +49-391-67-17311
- serban-dan.costa at med.ovgu.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsfrauenklinik
- Mr. OA Dr. med. Holm Eggeman
- Gerhart-Hauptmann-Straße 35
- 39108 Magdeburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49-391-67-17473
- [---]*
- holm.eggemann at med.ovgu.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsfrauenklinik
- Mr. OA Dr. med. Holm Eggemann
- Gerhart-Hauptmann-Str. 35
- 39108 Magdeburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49-391-67-17473
- [---]*
- holm.eggemann at med.ovgu.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsfrauenklinik
- Mr. Prof. Dr. med. Serban-Dan Costa
- Gerhart-Hauptmann-Str. 35
- 39108 Magdeburg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49-391-67-17301
- +49-391-67-17311
- serban-dan.costa at med.ovgu.de
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2013/09/13