scholarly journals Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

2020 ◽  
Author(s):  
Wenwen Wang ◽  
Xiangyi Ma ◽  
Wei Zhang ◽  
Zhiying Li ◽  
Yan Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Conservative Surgery ◽  
Postoperative Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Triptorelin Acetate

Abstract Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate. Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery. Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

scholarly journals Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

2019 ◽  
Author(s):  
Wenwen Wang ◽  
Xiangyi Ma ◽  
Wei Zhang ◽  
Zhiying Li ◽  
Yan Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Conservative Surgery ◽  
Postoperative Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Triptorelin Acetate

Abstract Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate. Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery. Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

scholarly journals Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

2019 ◽  
Author(s):  
Wenwen Wang ◽  
Xiangyi Ma ◽  
Wei Zhang ◽  
Zhiying Li ◽  
Yan Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Conservative Surgery ◽  
Postoperative Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Triptorelin Acetate

Abstract Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate. Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery. Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

scholarly journals Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial

2019 ◽  
Author(s):  
Wenwen Wang ◽  
Xiangyi Ma ◽  
Wei Zhang ◽  
Zhiying Li ◽  
Yan Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Conservative Surgery ◽  
Postoperative Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Triptorelin Acetate

Abstract Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate. Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery. Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

scholarly journals Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

2017 ◽  
Vol 10 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Katharine Hamlin ◽  
Christopher Munro ◽  
Scott L. Barker ◽  
Sean McKenna ◽  
Kapil Kumar
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Open Release ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

scholarly journals Electroacupuncture for postoperative pain after nasal endoscopic surgery: Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Qing Zhang ◽  
Xuan Yin ◽  
Hongyu Yue ◽  
Wei Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Endoscopic Surgery ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Electroacupuncture Treatment

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This trial protocol provides an example of clinical application for the management of postoperative pain using electroacupuncture treatment. If the electroacupuncture treatment protocol confirms that this treatment method is effective and safe, it can be implemented as a standard of care for relieving postoperative pain in Chinese and Western medicine.

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