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Study protocol
Shixuan Wang
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Corresponding Author
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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.
Keywords
focal adenomyosis, adenomyomectomy, relapse, triptorelin acetate
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CURRENT STATUS: Published
View the published article at Trials.
Version 4
Posted 24 Feb, 2020
No community comments so far
Editorial decision: Accept
On 28 Mar, 2020
Editor assigned
On 24 Feb, 2020
Submission checks complete
On 23 Feb, 2020
No comments provided
Editorial decision: Minor revision
On 07 Feb, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Editor assigned
On 19 Dec, 2019
Submission checks complete
On 18 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 09 Dec, 2019
Editor assigned
On 26 Nov, 2019
Submission checks complete
On 25 Nov, 2019
No comments provided
Editorial decision: Major revision
On 07 Nov, 2019
Reviewer #2 agreed
On 27 Oct, 2019
Review #2 received
Received 27 Oct, 2019
Reviewers invited
Invitations sent on 23 Oct, 2019
Reviewer #1 agreed
On 23 Oct, 2019
Review #1 received
Received 23 Oct, 2019
Editor assigned
On 06 Sep, 2019
Submission checks complete
On 25 Jul, 2019
First submitted
On 12 Jun, 2019
Metrics
Comments: 0
PDF Downloads: ...
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Shixuan Wang
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 4
Posted 24 Feb, 2020
No community comments so far
Editorial decision: Accept
On 28 Mar, 2020
Editor assigned
On 24 Feb, 2020
Submission checks complete
On 23 Feb, 2020
No comments provided
Editorial decision: Minor revision
On 07 Feb, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Editor assigned
On 19 Dec, 2019
Submission checks complete
On 18 Dec, 2019
No comments provided
Editorial decision: Minor revision
On 09 Dec, 2019
Editor assigned
On 26 Nov, 2019
Submission checks complete
On 25 Nov, 2019
No comments provided
Editorial decision: Major revision
On 07 Nov, 2019
Reviewer #2 agreed
On 27 Oct, 2019
Review #2 received
Received 27 Oct, 2019
Reviewers invited
Invitations sent on 23 Oct, 2019
Reviewer #1 agreed
On 23 Oct, 2019
Review #1 received
Received 23 Oct, 2019
Editor assigned
On 06 Sep, 2019
Submission checks complete
On 25 Jul, 2019
First submitted
On 12 Jun, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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