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Myoma clinical trials

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NCT ID: NCT02737553 Completed - Myoma Clinical Trials

Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal

Start date: October 2016
Phase: N/A
Study type: Interventional

Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic surgery. For this reason, electromechanical morcellation has long been used to facilitate the tissue removal in gynecology. However, electromechanical morcellation has long been performed inside the abdomen without any containment. Therefore, this practice has recently undergone increased scrutiny because of important concerns related to tissue dissemination during intracorporeal power morcellation. Thus, the US Food and Drug Administration released a safety communication discouraging power morcellation in laparoscopic hysterectomy and myomectomy procedures in April 2014. As a result of this serious concern, the enclosed laparoscopic power morcellation has been come into prominence in gynecological surgery. Besides the removal of the tissues through vagina with posterior colpotomy is considered an another solution for this critical problem. In the literature the comparison for the two techniques for tissue removal is considerably scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic enclosed electromechanical morcellation and tissue removal thorough vagina with posterior colpotomy according to surgical time, postoperative pain and postoperative sexual function.

NCT ID: NCT02661087 Withdrawn - Clinical trials for Symptomatic Submucosal Myoma

Comparing Intra Uterine Synechiae Occurence Using Bipolar Energy Compared With Monopolar Energy in Myoma Resection on Women Having Menorraghia and/or Infertility

Start date: March 14, 2017
Phase: N/A
Study type: Interventional

Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current. It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

NCT ID: NCT02377492 Withdrawn - Myoma Clinical Trials

Paracervical Vasopressin Injection Compared With Intramyometrial Vasopressin in Abdominal Myomectomy

Start date: March 2015
Phase: N/A
Study type: Interventional

The goal of the investigators study is to evaluate the effectiveness of paracervical injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The investigators will continue to use intramyometrial vasopressin as this has previously been shown to be effective. The study will not exceed the safely documented dose of vasopressin.

NCT ID: NCT02103933 Not yet recruiting - Gynecologic Cancer Clinical Trials

Pilot Study to Evaluate the Knowledge and Understanding on Surgery for Patients With Hysterectomy

Start date: April 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess the level of knowledge of surgery for women who underwent hysterectomy

NCT ID: NCT01829022 Completed - Myoma Clinical Trials

Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures

E-NOTES
Start date: April 2013
Phase: N/A
Study type: Observational

Primary objectives : To investigate technical feasibility and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with Traction of Multidirectional Sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.

NCT ID: NCT01564602 Recruiting - Adenomyosis Clinical Trials

To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

Start date: January 2011
Phase: N/A
Study type: Interventional

The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.

NCT ID: NCT01537822 Completed - Clinical trials for Residual Placental Tissue

The Hysteroscopic Morcellator (HM).

HM
Start date: May 2011
Phase: N/A
Study type: Interventional

Rationale: The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps, myomas and placental tissue. It withholds some technical advantages over resectoscopy. Previous data suggest that it's a faster technique than the latter, and shows that it has a low complication rate. Objective: To compare the HM to bipolar resectoscopy for removal of: 1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue, in terms of efficiency and complications. Study design: Single blind, randomized controlled multicenter trial. Study population: Women aged over 18 years old with: 1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual placental tissue, who are planned for hysteroscopic removal. Intervention: Patients are randomized between removal with the HM or the bipolar resectoscope. Main study parameters/endpoints: Installation and operating time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women who are referred to our polyclinic will be seen on a first visit, and, according to the standard work-up, an ultrasound will be performed when intrauterine pathology is suspected. To confirm the diagnosis a saline infusion sonography (SIS) and/or ambulant diagnostic hysteroscopy will be performed consequently. Once the diagnosis is confirmed and surgery is planned, women will be asked whether they want to take part in this study. At this moment, both techniques are used in our hospitals and the choice of treatment depends on the preference of the gynaecologist. All women will be treated with operative hysteroscopy in a daycare setting according to the standard of care, only now randomized between the two techniques. A standard postoperative visit with ultrasound examination and/or ambulant diagnostic hysteroscopy is scheduled 6 weeks later. Late postoperative complications and complaints are recorded. It is expected that the HM beholds some advantages over the bipolar resectoscope such as shorter operating time and less complications (e.g. risk of perforation, current and fluid related complications). Previous data do not demonstrate any additional risks related to the use of the HM. Moreover we will check whether the HM has a lower risk of intrauterine adhesion formation, as this might influence patient's fertility. After completion of the RCT, an observational study is planned considering pregnancies subsequent to the hysteroscopic procedure.

NCT ID: NCT01412489 Completed - Myoma Clinical Trials

Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

HYGEM
Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

NCT ID: NCT01032213 Completed - Myoma Clinical Trials

Effect of Magnesium Sulphate on Coagulation

Start date: January 2010
Phase: N/A
Study type: Interventional

Arterial and venous thrombotic events are the clinical manifestation of postoperative hypercoagulability. Altered serum magnesium may play a role in the balance of coagulation. In this study, the investigators investigated the effect of magnesium sulphate on the postoperative coagulation change in total intravenous anesthesia (TIVA).

NCT ID: NCT00898170 Completed - Hypertension Clinical Trials

Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Start date: May 2008
Phase: N/A
Study type: Interventional

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.