Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

35 patients undergoing laparoscopic ovarian cystectomy A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp

35 patients undergoing laparoscopic ovarian cystectomy It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.

• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp

Laparoendoscpoic single site surgery LESS

• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.

Conventional multiport laparoscopy

The aim of this work is to evaluate the postoperative consequences of laparoendoscopic single site surgery relative to conventional laparoscopy in presumed benign ovarian cyst.

The hypothesis is that single incision technique might offer advantages over the standard multi-port laparoscopy as potentially leading to less postoperative pain and improved cosmoses from a relatively hidden umbilical scar, as well as risk reduction of postoperative wound infection, hernia formation and elimination of multiple trocar site closure

Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy

Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Presumed Benign Ovarian Cystectomy: A Randomized Controlled Trial

The pain will be assessed by a numeric rating scale of 0-10

the time between the start of the incision up to the cutaneous closing of the trocar orifices

Ain Shams University

Doctor

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):

* During the inclusion visit,
* At the postoperative visit,
* At the 6-month follow-up visit

For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):

* At the inclusion visit,
* During the postoperative visit,
* At the follow-up visits (6 months post-surgery and then every 6 months until 24 months)

For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):

* At the inclusion visit,
* During the postoperative visit,
* During pre- and post-chemotherapy visits (before and after each cycle)
* During follow-up visits (every 4 months until 24 months)

Salivary samples

Raffaèle Fauvet, Pr

Philippe Descamps, Pr

Laetitia Elisabeth Rocca, Dr

François Golfier, Pr

Mathieu Poilblanc, Dr

Marie Gosset, MD

Sandrine Richard, Dr

Sofiane Bendifallah, Dr

Cyril Touboul, Pr

Emile Darai, Pr

Vincent Lavoué, Pr

Vinvent Lavoué, Pr

Claire Marie Roger, MD

Clotilde Hennetier, MD

Ludivine Genre, MD

Lobna Ouldamer, Pr

Lobna Ouldamer

OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in 8 obstetrics and gynecology departments in France; in order to describe the evolution of salivary miRNA expression between the pre-operative and post-therapy visits according to the type of mass. In time, the clinical application will be to significantly reduce the time to diagnosis and improve the care pathway for ovarian adnexal mass.

The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care.

The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.

In this study, the management and follow-up of patients :

* Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
* Are not modified in comparison with the usual follow-up, except for the performance of the Collection of saliva

Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin

Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study

Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects

Monitoring Force Group

iGenSeq

ZIWIG

Coagulants

All Drugs and Chemicals

Hemostatics

Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery

Bipolar electrocauterization during surgery Drug(-)

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Surgiguard

Hee Seung Kim, MD/PhD

The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy

In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination

PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

ovarian volume measured by ultrasonography

Seoul National University Hospital

Associate Professor, Department of Obstetrics & Gynecology

Sarcoma

Uterine Cervical Neoplasms

Endometriosis

Adenomyosis

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Pathological Conditions, Anatomical

Soft Tissue Sarcoma

Uterine Sarcoma

Patients will be intravenously injected ICG (Yichuang Pharmaceutical Limited Liability Company, Dandong, China) at a dose of 2-5 mg per kg of body weight before surgery or 0.25-0.5 mg per kg of body weight during surgery. Then, a NIR imaging systems included the NIR (800-900 nm) and white-light (400-650nm) dual-channel will be used to detect In situ lesions, metastatic lesions, lymph nodes, obturator nerve, pelvic autonomic nerve, etc during surgery according to disease and clinical needs.

Patients will be intravenously injected ICG (Yichuang Pharmaceutical Limited Liability Company, Dandong, China) at a dose of 2-5 mg per kg of body weight before surgery or 0.25-0.5 mg per kg of body weight during surgery. Then real-time near-infrared imaging will be conducted during surgery.

Intravenous ICG and Real-Time Near-infrared Imaging

Chunlin Chen, MD/PhD

chunlin chen, MD/PhD

Removing in situ and metastasis lesions completely during gynecological surgery is central to reduce the recurrence and death, and the identification of lesions in traditional gynecological surgery often depends on the experience of surgeons. The identification of nerves is often needed in gynecological surgery, such as the obturator nerves in pelvic lymphadenectomy, and the pelvic autonomic nerves in nerve-sparing radical hysterectomy for cervical cancer. Nerve identification also relies heavily on the experience of surgeons. This project aims to realize the identification of lesions and nerves under the navigation of indocyanine green fluorescent imaging, and evaluate the accuracy of fluorescent imaging of lesions and the effectiveness of nerves identification by near-infrared imaging. This project may reduce the recurrence or death caused by residual lesions and postoperative dysfunction caused by nerves injury, thus, improve the survival rate and quality of life for patients with gynecological diseases.

The Application of Real-Time Near-infrared Imaging in Gynecological Surgery

Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery

Evaluation of the effectiveness of real-time near-infrared imaging in detecting the margin of in situ lesions, whether there is metastasis lesions and whether the metastasis lesions has been completely removed , lymph node metastasis or not during gynecological surgery. The criteria of evaluation is postoperative pathological results and fluorescence intensity of specimen sections measured by laser scanning confocal microscope.

Evaluation of the effectiveness of real-time near-infrared imaging in detecting nerves associated with gynecological surgery, including the pelvic autonomic nerves composed of the abdominal aortic plexus, the superior hypogastric plexus, the hypogastric nerves, the pelvic splanchnic nerves, the inferior hypogastric plexus and its branches, obturator nerves, genitofemoral nerve, etc.

Chinese Academy of Sciences

Chen Chunlin

Department of Obstetrics and Gynecology

The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.

the absorbable hemostat and suture

The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.

electrocoagulation and suture

The placebo comparator is to use suture alone for hemostasis.

suture

Yanru Long

The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.

Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

Antral follicle count (AFC) generally refers to the basic follicles in ovaries, which have not yet begun to develop. If the number of AFC is within the normal range (usually 5-10), it indicates that the ovarian reserve function is normal. If the number is low, it generally means that the ovarian reserve function is relatively low. If the number is high, it may be caused by polycystic ovary syndrome. Besides, AFC can be detected through ultrasound examination, and the number of AFC can directly reflect the ovarian reserve of each ovary.

Anti-Mullerian hormone (AMH), which can be detected through blood tests, is considered a reliable marker produced by ovarian granulosa cells. The level of AMH indirectly reflects the number of ovarian follicular pools and the joint reserve of both ovaries. In addition, the level of AMH fluctuates less throughout the menstrual cycle. Besides, AMH is almost unrelated to the menstrual cycle and is not affected by gonadotropin-releasing hormone (GnRH) agonists or oral contraceptives.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic Single-site Surgery Versus Conventional Entry in Ovarian Cystectomy	NCT04788498	Ovarian Cyst Be...	Laparoendoscpoi... Conventional mu...	18 Years - 45 Years	Ain Shams University
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin	NCT05514028	Ovarian Cancer Ovarian Cyst Be... Borderline Ovar...	Salivary sample...	18 Years -	ZIWIG
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy	NCT03374397	Ovarian Cyst Be...	Surgiguard	18 Years - 45 Years	Seoul National University Hospital
The Application of Real-Time Near-infrared Imaging in Gynecological Surgery	NCT04224467	Cervical Cancer Ovarian Tumor Endometrial Car... Uterine Myomato... Adenomyosis Ovarian Cyst Be... Ovarian Cyst Ma... Endometriosis Uterine Sarcoma	Intravenous ICG...	18 Years - 80 Years	Southern Medical University, China
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin	NCT05514028	Ovarian Cancer Ovarian Cyst Be... Borderline Ovar...	Salivary sample...	18 Years -	ZIWIG
The Application of Real-Time Near-infrared Imaging in Gynecological Surgery	NCT04224467	Cervical Cancer Ovarian Tumor Endometrial Car... Uterine Myomato... Adenomyosis Ovarian Cyst Be... Ovarian Cyst Ma... Endometriosis Uterine Sarcoma	Intravenous ICG...	18 Years - 80 Years	Southern Medical University, China
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst	NCT06350227	Ovarian Cyst Be...	the absorbable ... electrocoagulat... suture	18 Years - 40 Years	West China Second University Hospital

Spots Global Cancer Trial Database for ovarian cyst benign