Neoplasms

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Pathological Conditions, Anatomical

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Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Ovarian Cancer

Ovarian Epithelial Cancer

TLH _adnexal preservation

Fulvio Zullo

Roberta Venturella, MD

Daniela Lico, MD

Roberta Venturella

The aim of this RCT of study is to compare the standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes

Ovarian cancer accounts for 3% of all female cancers and represents the fifth leading cause of cancer death in the Western world (1). In 90% of cases, these are epithelial ovarian cancers (2).

Because of the biological aggressiveness of this tumor and nonspecific symptoms, that causes a diagnosis at an advanced stage in 75% of cases, ovarian cancer is the gynecological cancer with the highest mortality rate (3).

To date, an effective screening strategy to the early diagnosis of ovarian cancer doesn't exist, so the prophylactic adnexectomy is the only available tool to reduce the incidence and the mortality rate, even if the role of this surgical strategy is controversial, especially in premenopausal women (4). In fact, the American College of Obstetricians and Gynaecologists (ACOG) guidelines recommend the ovarian preservation in premenopausal women with no family history or other risk factors for ovarian cancer (5).

Some clinical studies have shown that the prophylactic adnexectomy and the consequent surgical menopause increase significantly the long term risk of cardiovascular and psychosexual diseases. (6-8). In particular, a case-control study done in a population of 29,380 women subjected to hysterectomy with and without adnexectomy, showed an increased risk of total mortality ( HRs 1.12 95 % CI 1:03 to 1:21 ), lethal and non- lethal cardiovascular disease ( HRs 1.17 95 % CI 1:02 to 1:35 ) and stroke ( HRs 1.14 95 % CI 0.98-1.33 ) (9) . In this population of women subjected to salpingectomy, the surgery wasn't able to lead to an improvement in general survival (10).

Considering the new histopathological classification of the epithelial ovarian cancer, proposed by Kurman (11) and based on new acquisitions about the pathogenesis and the origin of these tumors, it is possible to conceive a new preventive strategy associated with a less morbidity.

In fact, the carcinogenesis model proposed by Kurman, provides for the classification of the most important histological types of epithelial tumors into two types, diversified according to clinico-pathological and genetic features.

The type I is composed of low-grade serous, low-grade endometrioid, clear cell and mucinous carcinomas, whose the ovarian borderline tumors and endometriosis represent the pre-neoplastic lesions. Conversely, the II type includes high-grade endometrioid carcinomas, carcinosarcomas and undifferentiated carcinomas and, more frequently, high-grade serous carcinomas, whose preneoplastic lesion, now, seems to be represented by the serous tubal intraepithelial carcinoma (STIC).

Plenty of evidence, to support the correlation between the epithelial ovarian cancer and the STIC, has been obtained by immunohistochemical and molecular genetics investigations (11). However, from a clinical point of view, this association has been demonstrated only by a study on 55 patients affected by a high-grade serous carcinoma, whose results have shown an involvement in the endosalpinx in 70% of cases and the presence of STIC in about 50% of cases (12).

Some studies, performed on BRCA1 / 2 populations, showed the presence of strongly sites reactive to p53, defined "p53 signature", in the distal tube (13). These sites seem to be more frequent and characteristically multifocal in those tubes with concomitant STIC (14). The finding of "p53 signature" may, therefore, identify an early clonal expansion of the neoplastic proliferation.

This new theory has given the opportunity to prevent this devastating type of cancer by the addition of the prophylactic bilateral salpingectomy (PBS, with the only removal of the tube and the preservation of the ovaries) in all surgical procedures performed in those women with benign diseases once they have accomplished their reproductive desire. The PBS, in place of the current standard procedure (bilateral salpingo-oophorectomy) could reduce the risk of cancer, improving at the same time the quality of life and reducing the risk of premature death due to cardiovascular disease, seen in women subjected to salpingo-oophorectomy before the onset of natural menopause.

Our preliminary data (17) show that, if the bilateral salpingectomy is performed with great care, no patient has negative effects in terms of ovarian function. In addition, in our experience, no perioperative complication is attributable to salpingectomy alone. Despite the retrospective design of our first study, according to the post hoc analysis, these data have shown a significant statistical reliability.

However, prospective data on the effetc of PBS in patients submitted to TLH are still needed

Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy

The Effect in Term of Ovarian Reserve Modification of Adding Prophylactic Bilateral Salpingectomy (PBS) to TLH for Preventing Ovarian Cancer

Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI

University Magna Graecia

Full Professor Obstetric Gynecology

Behaviors and Mental Disorders

Carcinoma

Adenocarcinoma

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Quality of Life

For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.

Total Abdominal Hysterectomy

The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.

Total Laparoscopic Hysterectomy

Andreas Obermair

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.

The secondary hypotheses are:

* TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;
* TLH is associated with reduced treatment-related morbidity;
* TLH is associated with shorter hospital stay;
* TLH is associated with less analgesic consumption;
* TLH is cost effective;
* TLH is associated with improved pelvic floor function.

Laparoscopic Approach to Cancer of the Endometrium

LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tyco Healthcare Group

Gynetech

Queensland Government - Smart Health Research Grant

National Health and Medical Research Council, Australia

Cancer Council Queensland

Cancer Council New South Wales

Cancer Council Victoria

Cancer Council Western Australia

Cancer Australia

Queensland Centre for Gynaecological Cancer

Hemorrhage

Endometriosis

Uterine Hemorrhage

Neoplasms, Connective Tissue

Connective Tissue Diseases

Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.

Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.

Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

Kimberly A Kho, MD

The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.

The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.

Objectives:

1. To evaluate differences in total operating time between subjects undergoing AM compared to VM.
2. To evaluate differences in morcellation time between AM and VM.
3. To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
4. To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
5. To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
7. To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
8. To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.

Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

A Comparison of Perioperative and Patient-Centered Outcomes With Abdominal Versus Vaginal Morcellation: A Randomized-Controlled Trial

Total operating room time is defined as skin incision to skin closure

Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being "very dissatisfied" with overall body image

Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced

Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery

Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life

Defined as specimen bag introduction to specimen bag removal

Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality

The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy	NCT02086344	Uterine Fibroid... Adenomyosis Pelvic Pain Pelvic Prolapse	PBS TLH _adnexal pr...	35 Years - 50 Years	University Magna Graecia
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy	NCT04434066	Abnormal Uterin... Uterine Bleedin... Fibroid Uterus Surgery	Total Laparosco...	18 Years - 50 Years	University of Texas Southwestern Medical Center
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer
Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy	NCT02086344	Uterine Fibroid... Adenomyosis Pelvic Pain Pelvic Prolapse	PBS TLH _adnexal pr...	35 Years - 50 Years	University Magna Graecia
Laparoscopic Approach to Cancer of the Endometrium	NCT00096408	Endometrial Can...	Total Abdominal... Total Laparosco...	18 Years -	Queensland Centre for Gynaecological Cancer

Spots Global Cancer Trial Database for total laparoscopic hysterectomy