Hysterectomy Clinical Trial
Official title:
Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
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.
Around 600,000 hysterectomies are performed every year in the United States, making
hysterectomy the second most common surgery for women, first being cesarean section. Most of
the hysterectomies are done for non cancerous conditions. And the most common indication for
the same is symptomatic fibroid uterus.
In spite of being the most common gynaecological surgery the route of hysterectomy has always
been an issue of debate since early 19th century. In the beginning it started as vaginal
hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as
the recent minimally invasive route the choices have further increased. Laparoscopic route
has prompted the need for development of other forms of hysterectomy which are minimally
invasive and are associated with less perioperative morbidity with better postoperative
outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route
includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic
Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route
is preferable because it is associated with less perioperative morbidity and faster recovery.
Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy
when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic
pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a
long learning curve involved in the training, and the operating time with this route is
prolonged.
The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as
the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy
hysterectomy as an alternative minimally invasive surgery method was started. It relies on
traditional open techniques and inexpensive instrumentation, making it significantly faster
than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy
procedure effective and safe in non-obese women in whom vaginal approach was contraindicated.
Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy
hysterectomy and found it to be a feasible route of surgery in benign gynaecological
conditions with operative time similar or shorter as compared to vaginal, laparotomy and
laparoscopy surgery. Few surgeons have modified the incision depending on the their
experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.
The final choice of the route and method depends on multiple factors which include indication
of surgery, size of fibroid, equipments available in the surgical set up, surgeons'
expertise, patient's financial background.
All patients followed the same standard pre-operative protocol. All surgeries were performed
under general anesthesia with endotracheal intubation. Demographic details that included age,
parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were
collated a day prior to the day of surgery. On admission, patients were informed in detail
about the operation modalities and the associated complications. Patients along with their
relatives were counselled about the advantages and disadvantages of both the surgical methods
and the final decision was made on a joint consensus between the surgeon and the patient,
following which an informed written consent was obtained.
The aim of the study was to compare the feasibility of two minimally invasive surgical
procedures in low resource settings (such as India) - Laparoscopic assisted vaginal
hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision <7cm).
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