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Genital Diseases, Female clinical trials

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NCT ID: NCT03093675 Completed - Uterine Diseases Clinical Trials

Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

Start date: October 23, 2013
Phase: N/A
Study type: Interventional

This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.

NCT ID: NCT03007654 Recruiting - Gynecologic Disease Clinical Trials

Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

antiadhesion
Start date: December 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

NCT ID: NCT02957500 Recruiting - Gynecologic Disease Clinical Trials

To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

antiadhesion
Start date: November 22, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

NCT ID: NCT02851186 Completed - Postoperative Pain Clinical Trials

Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

Start date: October 12, 2016
Phase: N/A
Study type: Interventional

Objectives: To examine the efficacy and safety of electroacupuncture (EA) combined with auricular acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for gynecological diseases. Hypothesis: Acupuncture is effective and safe to reduce postoperative pain during the first 5 days following surgery as compared to a sham control. Design and strategy: This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or sham control. Subjects in both groups will undergo standard operation procedure and receive post-operative analgesics based on usual care. Study instrument: A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome assessment. Intervention: Subjects in the treatment group will receive EA combined with AA within two hours before operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days. Subjects in the control group will receive non-invasive sham procedure in the same schedule. Main outcome measures: Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge. Secondary outcome: Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D, EQ-5D-5L and adverse events will be documented and compared between groups. Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's T-test. Expected outcome: AUC of the acupuncture group is expected to be significantly lower than sham acupuncture group.

NCT ID: NCT02811081 Completed - Clinical trials for Gynecologic Diseases

Effective Maneuver for Post-laparoscopic Shoulder Pain

Start date: June 26, 2016
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

NCT ID: NCT02747641 Completed - Vaginal Atrophy Clinical Trials

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

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

The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

NCT ID: NCT02729272 Completed - Clinical trials for Gynecologic Diseases

Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

ULMOST
Start date: April 2016
Phase: N/A
Study type: Interventional

The aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

NCT ID: NCT02698527 Completed - Clinical trials for Genital Diseases, Female

The Effect of Buffered Lidocaine Versus Nonbuffered Lidocaine on Pain Scores During Infiltration for Vulvar Biopsies

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

Objective: To compare pain scores on a visual analogue scale during infiltration of local anesthetic for vulvar biopsies between women who are treated with buffered versus non- buffered lidocaine Hypothesis: Patients treated with buffered lidocaine at the site of vulvar biopsy will have lower pain scores on a visual analogue scale during the biopsy. Study Design: Double blinded randomized controlled trial Population: Women undergoing vulvar biopsy at the Women's Primary Care Center and The Program In Women's Oncology Clinic of a non-infectious vulvar lesion.

NCT ID: NCT02642835 Completed - Clinical trials for Pelvic Organ Prolapse

A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

Start date: August 2015
Phase:
Study type: Observational

Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time. Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.

NCT ID: NCT02634242 Completed - Clinical trials for Gynecological Disorders

Study on the Antiaging Effect of Chinese Herb Drink

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

The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.