Comparative Study of LAVH and Minilaparotomy Hysterectomy (NCT03548831) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study of LAVH and Minilaparotomy Hysterectomy
52 participantsStarted 2014-08
Plain-language summary
Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non descent uterus with benign gynaecological conditions
Exclusion Criteria:
* Uterine size \> 20 weeks
* Minilaparotomy was contraindicated in patients where severe adhesions might exist eg -
* Endometriosis
* Previous pelvic inflammatory disease
* Patients with one or more contraindications for LAVH were excluded -
* Cardiac or respiratory morbidity contraindicating laparoscopy
* Frozen pelvis
* Cervix flushed with vagina
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study compared two surgical approaches — laparoscopic-assisted vaginal hysterectomy and minilaparotomy hysterectomy — and measured blood loss and pain after surgery; based on the completed results, which of these two approaches does my doctor think would be safer or better tolerated for my specific situation?
2Since this trial tracked how long each surgery took as a primary outcome, can my doctor explain whether the difference in operating time between the two methods would matter for my recovery or for any risks related to anesthesia?
3Given that this was a comparative study looking at postoperative pain, what do the findings suggest about how much pain I should expect with each approach, and how would that be managed in my case?
4Both of these are minimally invasive options for benign gynecologic conditions like mine, but are there reasons my doctor might recommend a different surgical approach entirely — including a standard open hysterectomy — rather than either of the two methods studied here?
5Now that this trial is completed, has my doctor seen or reviewed the results, and do those findings actually change the recommendation they would make for my surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of surgery
Timeframe: Intra operatively
2
Blood loss
Timeframe: Intra operatively
3
Postoperative pain
Timeframe: Starting from immediate post-operative period till 72 hours.