Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology.

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 3D 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 standard laparoscopy technology. 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.

3D Laparoscopy

Standard Laparoscopy

This prospective randomized pilot study is aimed to verify if the operative time of a total laparoscopical hysterectomy (TLH) with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using 3D laparoscopy versus standard laparoscopy

The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures include washing for cytology, total extrafascial hysterectomy and bilateral salpinges-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 salpinges-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, patients with clinical stage I to IIA uterine cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpinges-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 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 salpinges-oophorectomy and not a complete surgical staging including pelvic and para-aortic lymphadenectomy.

In the Australian LACE study 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 salpinges-oophorectomy and bilateral pelvic lymphadenectomy. 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) infect 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 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.

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 3D laparoscopy (Olympus Medical Systems Corp) vs standard laparoscopy .

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, days of hospitalization and costs for the health care system.

2D Versus 3D Radical Laparoscopic Hysterectomy for Endometrial Cancer: a Prospective Randomized Trial

Prospective Randomized Trial on 2D Versus 3D Laparoscopic Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II

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

Fagotti, Anna, M.D.

Fanfani, Francesco, M.D.

Catholic University of the Sacred Heart

Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Hemorrhage

Prolapse

Leiomyoma

Myofibroma

Uterine Prolapse

Uterine Hemorrhage

Pathological Conditions, Anatomical

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Pelvic Organ Prolapse

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 3D laparoscopic camera

Patients submitted to vaginal cuff closure after total laparoscopic hysterectomy using a 4k laparoscopic camera

Francesco Fanfani, Professor

Stefano Restaino, MD

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and / or magnetic resonance and / or CT) and with indication for total laparoscopic hysterectomy with consequently need for laparoscopic suture of the vaginal cuff, will be enrolled in the study.

- I TIME/OUT OF PROTOCOL TIME (performed by expert surgeons) While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. 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° 4K high-definition telescope (VISERA UHD 4K 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany).

Two additional 5 mm ports are placed under direct visualization, in the right lower abdomen medial to the right obliterated umbilical artery and in the left lower abdomen lateral to the inferior epigastric vessels. 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. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique.

- II TIME/PROTOCOL TIME (performed by surgeon in training) The vaginal vault is closed with a 0 Vycril suture laparoscopically (continuous suture). In order to avoid excess operating time, 15 min was allocated for completion of cuff closure by surgeons-in-training, after which time the attending surgeon took over this task.

Operative time, estimated blood loss, incidence of intra or post-operative complications, postoperative pain, days of hospitalization and costs will be recordered

4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

- Evaluate the incidence of postoperative complications (dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

To compare the time taken to close the vaginal cuff, which was defined as time, starting from the initial grasp of the suture to cutting the suture, with 3D Laparoscopy vs 4K laparoscopy

Evaluate the incidence of intraoperative complications in the two laparoscopic system (intraoperative blood loss, need for intraoperative transfusions, bladder lesions, ureteral lesions, vascular lesions, intestinal lesions)

professor

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology.

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 3D 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 radical hysterectomy with pelvic lymphadenectomy are performed with standard laparoscopy technology. 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.

The aim of this prospective randomized pilot study is to verify if the operative time of a Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard laparoscopy

Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA\<2cm. Since the early 90's laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRH) has been suggested as surgical approach for the treatment of cervical cancer. In the recent years, many institutions have begun to consider it an attractive technique and to study its feasibility and safety. Most of these studies have shown that LRH is relatively more time-consuming than standard laparotomy and ranges from 90 to 420 minutes according to surgeons' experience and different techniques adopted to achieve hemostasis, resect the parametrium and uterosacrals. Spirtos et al. demonstrated that staplers could reduce mean operation time from 253 to 205 minutes if compared to argon beam coagulator. Moreover, the pulsed bipolar system was associated with significant reduction in operative time in comparison with the conventional bipolar system (mean, 172 minutes vs 229 minutes; P \< 0.001). The largest series of LRH reported from a single institution by Puntambekar et al included 248 patients and described the "Pune technique" (anterior and posterior peritoneal U cuts, early dissection of the rectovaginal space, fully mobilization of the uterus, resection of the cardinal and uterosacral ligaments with Ligasure system (Ligasure Vessel Sealing System; Valleylab, Tyco Healthcare, Boulder, CO)), obtaining a very short mean operative time (mean, 92 minutes; range 6-120 minutes).

A recent review on laparoscopic and robot-assisted radical hysterectomy with pelvic lymphadenectomy including 17 studies reported a mean operating time of 202 minutes \[range, 184-221 minutes\] in the group of LRH, which matches with our experience of 210 min (range 180-240), using conventional bipolar electrosurgery.

This prospective randomized pilot study is aimed to verify if the operative time of a LRH with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) vs. standard laparoscopy.

Saving operative time would mean shorter anesthesia and faster recovery, further improving the safety profile of the laparoscopic approach in the treatment of cervical cancer.

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

2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial

Prospective Randomized Trial on2D Versus 3D Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response.

patients submitted to total hysterectomy using a 3D laparoscopic camera

patients submitted to total hysterectomy using a 2D laparoscopic camera (standard laparoscopic camera)

total laparoscopic hysterectomy using a 3D laparoscopy high-definition system

0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. 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 (HD EndoEye 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany). The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).

Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)

Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?

2D Versus 3D Total Laparoscopic Hysterectomy by Surgeons in Training: a Prospective Randomized Trial

To compare operative time for Total Laparoscopic Hysterectomy with 3D laparoscopy vs. conventional laparoscopy

• Evaluate the incidence of intraoperative complications in the two laparoscopic system (intraoperative blood loss, need for intraoperative transfusions, bladder lesions, ureteral lesions, vascular lesions, intestinal lesions)

Evaluate the incidence of postoperative complications (need for postoperative transfusions, dehiscence of the vaginal cuff, fever, urinary tract infections, surgical wound infections)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
2D Versus 3D Radical Laparoscopic Hysterectomy for Endometrial Cancer: a Prospective Randomized Trial	NCT02320565	Endometrial Can...	3D Laparoscopy Standard Laparo...	- 75 Years	Catholic University of the Sacred Heart
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial	NCT02320578	Uterine Cervica... Laparoscopic Su...	3D Laparoscopy Standard Laparo...	- 75 Years	Catholic University of the Sacred Heart
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart
4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial	NCT04637022	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...		-	Catholic University of the Sacred Heart
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?	NCT04209036	Uterine Fibroid Uterine Bleedin... Uterine Prolaps...	0° 3D laparosco...	-	Catholic University of the Sacred Heart

Spots Global Cancer Trial Database for 3d laparoscopy