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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy

The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.

The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.

Storz 3D Laparoscopy System

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

2D Laparoscopy

Jon Einarsson, MD, PhD, MPH

Sarah L Cohen, MD, MPH

The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.

This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy

The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.

The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.

Brigham and Women's Hospital

Division Chair, Minimally Invasive Gynecology

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy

2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.

Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.

3D Laparoscopy

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Denmark

Region of Enrollment

Jon I. Einarsson

Vaginal Cuff Closure Times

Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy

Overall Study

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Intraoperative sentinel lymph node identification (lymphatic mapping)

Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.

Intraoperative Lymphatic Mapping

Michael M. Frumovitz, MD

The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.

Experimental Procedures:

Lymph nodes are oval-shaped glands where immune reactions occur. For patients with endometrial cancer, lymph node status is an important factor for planning the cancer treatment course and predicting the status of the cancer. The "sentinel" node is the lymph node closest to the main tumor area, and it is believed to be at greatest risk for spread of the cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes are usually cancer-free.

In this study, researchers want to study possibly using lymphatic mapping in future patients as an alternative to completely removing the lymph nodes in the pelvis (hip area) and para-aortic (upper abdomen) area.

Intraoperative sentinel lymph node identification (lymphatic mapping) uses 2 techniques. The first technique involves injecting a small amount of weak radioactive material, and the second involves injecting a drug called isosulfan blue or methylene blue. These techniques are being studied to see if the surgeon can locate ("map") lymph nodes that may contain tumor cells.

Routine Surgical Treatment:

As part of routine care, all participants in this study will have surgery to remove the uterus, cervix, 1-2 inches of the vagina, fallopian tubes, ovaries, and the lymph nodes in 2 areas of the waist.

Study Procedures:

If you agree to take part in this study, after you have been given the anesthetic for your surgery, your uterus will be examined to locate the tumor(s). After the tumor(s) are located, they will be injected with a radioactive substance called Tc-99m sulfur colloid. The tumors will then be injected with a dye called isosulfan blue or methylene blue, which is used to turn the sentinel node blue.

Before and during your surgery, a gamma counter (a special hand-held instrument that measures radioactivity) will be used to identify lymph nodes that have absorbed the Tc-99m sulfur colloid. The surgeon will also be able to see the lymph nodes that have absorbed the blue dye.

Information Collection:

In addition to the study procedures, researchers will collect clinical information about you that will be compared with the study results. This information includes your date of birth, age, race, height, weight, number of any past pregnancies and deliveries, any other medical conditions, and any earlier surgeries. It also includes the date of the cancer diagnosis, the status of the cancer diagnosis before surgery, the status of the disease, and the results of routine scans before surgery (chest x-ray and computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan, if performed).

Length of Study Participation:

Your participation in this study will be over after the 15-20 minute procedure for identifying the sentinel nodes. The routine surgery will occur after that, which can take up to 5 hours.

This is an investigational study. Tc-99m sulfur colloid, the blue dye (either isosulfan blue or methylene blue), and the gamma counter are FDA approved for the procedures used in this study.

Performing lymph node mapping and sentinel node identification during surgery in patients with endometrial cancer is considered experimental.

Up to 20 women will take part in this multicenter study. Up to 10 will be enrolled at M. D. Anderson.

Hysteroscopic Lymphatic Mapping for Endometrial Cancer

Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer

Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.

M.D. Anderson Cancer Center

Early termination due to low detection rate of sentinel lymph nodes in the five participants.

Dr. Michael Frumovitz, ND/Assistant Professor

Analysis was per protocol; no analysis conducted due to low detection rate.

Sentinel Node Identification Rate

Endometriosis

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

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

University of Texas Southwestern Medical Center

Associate Professor

Coagulants

All Drugs and Chemicals

Hemostatics

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery.

A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope.

Two additional 5 mm ports are placed under direct visualization. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut.

Thunderbeat is used to coagulate the fallopian tubes, to coagulate and divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to incise the bladder peritoneum, to dissect the bladder, to develop rectovaginal septum, to cut parametria, and to divide the uterosacral ligaments. Thunderbeat is also used to perform the pelvic lymphadenectomy and, if necessary, the para-aortic lymphadenectomy.

Thunderbeat technology

Standard bipolar electrosurgery

Catholic University of Sacred the Hearth

Anna Fagotti, PhD

Francesco Fanfani, MD

Valerio Gallotta, MD

Giuseppe Vizzielli, MD

Elisa Piovano, MD

Raffaella Iodice

This prospective randomized pilot study is aimed to verify if the operative time of a TLH with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .

Secondary endpoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

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 patients.

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 nodes.

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 laparotomy.

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.

Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer

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.

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

Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?	NCT02192606	Uterine Fibroid... Abnormal Uterin... Pelvic Pain Adenomyosis	Storz 3D Laparo... 2D Laparoscopy	18 Years - 80 Years	Brigham and Women's Hospital
Hysteroscopic Lymphatic Mapping for Endometrial Cancer	NCT00671606	Endometrial Can...	Intraoperative ...	-	M.D. Anderson Cancer Center
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
Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer	NCT01717794	Endometrial Can...	Thunderbeat tec... Standard bipola...	- 75 Years	Catholic University of the Sacred Heart
Hysteroscopic Lymphatic Mapping for Endometrial Cancer	NCT00671606	Endometrial Can...	Intraoperative ...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for total hysterectomy