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Uterine Fibroid clinical trials

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NCT ID: NCT04068766 Recruiting - Uterine Fibroid Clinical Trials

Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)

PALM
Start date: August 23, 2019
Phase: N/A
Study type: Interventional

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to LM for benign gynecologic conditions on postoperative pain relief.

NCT ID: NCT03792009 Recruiting - Adenomyosis Clinical Trials

Paracervical Block in Laparoscopic Hysterectomy

PALAPA
Start date: February 21, 2019
Phase: N/A
Study type: Interventional

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

NCT ID: NCT03509168 Recruiting - Uterine Fibroid Clinical Trials

The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.

MM
Start date: January 10, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Open myomectomy remains the principal treatment for symptomatic fibroids in sub-Saharan countries irrespective of fertility desires. This however has got to be balanced against potential risks such as profuse hemorrhage; blood loss at open myomectomy remains dreary with the use of various pharmacologic agents yielding inconclusive results. This trial is aimed at exploring the benefit of preoperative use of a readily available uterotonic, Misoprostol in reduction of intraoperative blood loss during open myomectomy with the Null hypothesis stating: there is no difference in mean blood loss during open myomectomy whether one preoperatively inserts a single dose of 400mcg vaginal misoprostol or not. Alternate hypothesis: single dose 400mcg vaginal Misoprostol given 60 minutes preoperatively during open myomectomy reduces intra-operative blood loss by at least 20% as measured by surgical mops and suction. Participants from two referral hospitals in Uganda with symptomatic fibroids and scheduled for open myomectomy will be recruited. 48 women that meet the inclusion criteria and have none of the exclusion criteria and provide signed informed consent will be enrolled. The screening will be done on the gynecological wards and patients will be randomized to either the control or interventional arm by means of sealed, sequentially numbered opaque envelopes containing computer-generated random numbers. Blinding will affect theatre team and patients. Primary (blood loss as estimated by surgical mops and suction) and secondary endpoints (e.g. postoperative drop in Hb) will be calculated. Data analysis: Data will be analyzed on an intention-to-treat basis. Analysis will be done using STATA software 14.0. This will include descriptive statistics for measures of central tendency and dispersion. Student t-test and Mann Whitney U test will be used for mean blood loss. Stratification for age, parity, complaints, total fibroid mass and usage of other intraoperative blood-loss techniques will be analyzed. categorical data to be analyzed by coefficients. Results of this study are meant to better inform clinicians about the use of misoprostol for this role and possibly include it in the management protocols for open myomectomy in Sub-Saharan countries where burden of blood products is strained.

NCT ID: NCT03118037 Recruiting - Uterine Fibroid Clinical Trials

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

SAGE
Start date: June 14, 2017
Phase:
Study type: Observational [Patient Registry]

SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.

NCT ID: NCT01239641 Recruiting - Uterine Fibroid Clinical Trials

High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.