Know Cancer

forgot password

Prospective Randomized Trial on Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II: Thunderbeat Technology Versus Standard Bipolar Electro-surgery.

75 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

Prospective Randomized Trial on Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II: Thunderbeat Technology Versus Standard Bipolar Electro-surgery.

The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures
include washing for cytology, total extrafascial hysterectomy and bilateral
salpingo-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic
lymphadenectomy is debated, staging information is a critical determinant of adjuvant
therapy for most gynecologic oncologists.

Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are
positive lymph nodes, those around the obturator nerve and around the external and common
iliac vessels are more likely to be involved than those in the presacral area. Isolated
involvement of the para-aortic nodes is rare. Complete excision of the nodes located around
the iliac vessels and above the obturator nerve allows identification of 90% of node-positive

The decision on whether to undertake lymphadenectomy should not be based on palpation of the
nodal area, because less than 10% of patients with nodal metastases have grossly enlarged

Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3
endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph
nodes. In our current treatment protocol, these patients undergo complete pelvic
lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with
grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal infiltration.

Although the complication rate of a simple hysterectomy with bilateral salpingo-oophorectomy
is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal
women, commonly associated with medical co-morbidities, such as diabetes, hypertension and
obesity. Abdominal surgery therefore exposes them to an increased risk of complications.
Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery
for these patients, but this approach does not allow exploration of the abdominal cavity,
peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or
total laparoscopic hysterectomy overcome the previous limitations.

In 1993, Childers et al first proposed laparoscopy as an option for early-stage endometrial
cancer. Despite its recognized benefits, many surgeons found this approach difficult for
routine use such that relatively few centers offered laparoscopic hysterectomy and
lymphadenectomy for a majority of their patients.

From those first reports there have been 12 major reports on the use of laparoscopy, often
comparing to series of similar patients staged by laparotomy. Clear advantages, such as the
reduction of peri-operative complications, the shorter hospital stay and the earlier
recovery, have been confirmed in each series. Failure to complete the staging procedure by
laparoscopy ranges between 5 and 35% of the patients, most frequently due to obesity of the
patients. In reality in 2005 some researchers have suggested that laparoscopic surgery is
safe in obese or elderly patients with endometrial cancer too.

Moreover, this approach does not seem to modify the incidence of recurrence and overall
patient survival. The big randomized trials planned to study differences in morbidity and
survival between laparoscopy or laparotomy in endometrial cancer are the GOG LAP-2 study,
the Dutch study from Bijen and Mourits, and the Australian study LACE. Unfortunately none of
these three randomised trials have yet reported survival data, but only on health-related
issues and complications. In the GOG study 33, patients with clinical stage I to IIA uterine
cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920),
including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic
lymphadenectomy. Laparoscopy resulted in fewer postoperative moderate or severe adverse
events, a shorter hospital stay, and a longer operative time than did laparotomy. The
median operative time for the open laparotomy arm was 130 minutes (range 102-167 minutes),
and for the laparoscopy arm, it was 204 minutes (rang 160-252 minutes; P < .001).

In the Dutch 34-35 study the major and minor complication rates were the same in the group
of patients treated with laparoscopy compared with laparotomy. However, TLH was associated
with less blood loss, less use of pain medication, a shorter hospital stay, and a longer
operative time than with TAH. The median duration of surgery was 115 minutes in the TLH
group, (range 35-267) and 71 minutes (range 31-239) in the TAH group. The difference with
the GOG study is probably due to the fact that the patients in the Netherlands only
underwent a hysterectomy and bilateral salpingo-oophorectomy and not a complete surgical
staging including pelvic and para-aortic lymphadenectomy.

In the Australian LACE study 36 patients with stage I endometrioid adenocarcinoma were
randomly assigned to TLH (n=190) or TAH (n=142). Surgeons were required to perform pelvic
node (with or without) para-aortic lymph-node dissection as part of the treatment in both
groups. Operating time was significantly longer in the TLH group (138 minutes [SD 43]) than
in the TAH group (109 minutes [34]; p=0•001).

Health-related outcome was reported in all three trials. Better physical functioning, body
image, reduced pain, and an earlier resumption of work over the 6-week post-laparoscopy
period was reported in the GOG and the Dutch study than in the laparotomy patients, but
these differences disappeared 6 months after surgery. In the Australian study, quality of
life was still improved 6 months after surgery.

In conclusion, laparoscopic treatment of endometrial cancer clinically confined to the
uterus is associated with less pain, shorter hospital stay, faster recovery, and better
quality of life at least 3 months post surgery, but with a longer operative time than with

Another recent single institution Italian trial randomized patients with clinical stage I
endometrial cancer to receive TLH (n=81) or TAH (n=78) with bilateral salpingo-oophorectomy
and bilateral pelvic lymphadenectomy. 37 Para-aortic lymphadenectomy was performed in
selected cases. The mean operative time was 123 minutes ± 29 (95% CI 111-198) in the LPT
group and 136 minutes ± 31 (95% CI 118- 181) in the LPS group (P<0.01). These operative
times match closely with our experience by both laparotomy and laparoscopy, using
conventional bipolar electrosurgery.

Shortening the operative time of laparoscopy could further increase the benefits of the
laparoscopic approach, especially in obese patients. Overweight (defined as body-mass index
[BMI] of at least 25 kg/m2) is an important risk factor present in almost 50% of women with
endometrial cancer.

Since these patients are characterised by several systemic physiopathological alterations,
the perioperative management may present some problems, mainly related to their respiratory
system (obstructive sleep apnea, airway intubation and atelectasis). Obstructive sleep
apnea-hypopnea syndrome (OSA) occurs in up to 70% of morbidly obese patients undergoing
surgery 39 being OSA a known risk factor for adverse perioperative outcomes.

Shortening the operative time could reduce these perioperative complications and the
postoperative pain. This could translate in fewer days of hospitalization and than lower
incidence of hospital infections and lower costs for the health care system.

Inclusion Criteria

Inclusion/Exclusion Criteria:

- Age ≤ 75 years

- Patient's informed consent

- American Society of Anesthesiologists: < class III or IV

- No actual pregnancies or P.I.D.

- No previous major abdominal surgical procedures

- Endometrial cancer FIGO stages IB-II

- Endometrioid histotype

- No previous radiotherapy on pelvic fields

- No uterine size larger than conform 10 weeks gestation

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Operative time for total laparoscopic hysterectomy with pelvic lymphadenectomy

Outcome Description:

Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.

Outcome Time Frame:

24 months

Safety Issue:



Italy: Ethics Committee, Catholic University of the Sacred Hearth

Study ID:

Thunder Endometrium



Start Date:

October 2012

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • operative time
  • laparoscopy
  • total hysterectomy
  • pelvic lymphadenectomy
  • endometrial cancer
  • Thunderbeat
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma