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CRIS문의

  • Status : Approved
    • First Submitted Date : 2019/07/06
    • Registered Date : 2019/07/11
    • Last Updated Date : 2019/07/11
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1. Background

Background Information
CRIS
Registration Number
KCT0004135 
Unique Protocol ID DUIH 2007-24 
Public/Brief Title A novel method of surgery for the infertile women with adenomyosis 
Scientific Title Prospective trial for evaluation of efficacy of conservative "debulking surgery" in infertile women with uterine adenomyosis  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number DUIH 2007-24 
Approval Date 2007-09-28 
Institutional Review Board  
Name Institutional Review Board, Dongguk University Ilsan Hospital 
Address 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 
Telephone 031-961-8405 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Ju-Won Roh 
Title Pf 
Telephone +82-31-961-7363 
Affiliation Dongguk University Ilsan Hospital 
Address 27, Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi, Korea 
Contact Person for Public Queries
Name Ju-Won Roh 
Title Pf 
Telephone +82-31-961-7363 
Affiliation Dongguk University Ilsan Hospital 
Address 27, Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi, Korea 
Contact Person for Updating Information
Name Ju-Won Roh 
Title Pf 
Telephone +82-31-961-7363 
Affiliation Dongguk University Ilsan Hospital 
Address 27, Dongguk-ro, Ilsandong-gu, Goyang, Gyeonggi, Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2008-01-18 , Actual
Target Number of Participant 50
Primary Completion Date 2016-03-17 , Actual
Study Completion Date 2016-09-30 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Dongguk University Ilsan Hospital 
Recruitment Status Completed  
Date of First Enrollment 2008-01-18 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Dongguk University Ilsan Hospital 
Organization Type Medical Institute  
Project ID DUIH 2007-24 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Dongguk University Ilsan Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Adenomyosis is a pathological finding characterized by heterotopic growth of endometrial glands and stroma into the myometrium and is accompanied by a varying degree of muscular hypertropic changes. Adenomyosis has been suggested to be associated with menstrual abnormalities, and affected women have compromised fertility; they often need assisted reproductive technology (ART) for reproduction. Similar to endometriosis, adenomyosis could impair a successful pregnancy during ART, even though the relation between uterine adenomyosis and infertility is not clearly defined. It appears to affect uterine or endometrial receptivity and increases the abortion rate. Adenomyosis is difficult to treat in infertile patients who need uterine conservation; medical treatment is often transient, and hysterectomy cannot preserve the patient’s fertility, even though it has been a standard surgical treatment for treating adenomyosis. Till date, there has been no consensus on the most appropriate therapeutic method for improving fertility outcome in infertile patients with adenomyosis. <br />Several studies have reported that various surgical methods, including endometrial resection, open or laparoscopic myometrial reduction by electrocautery, and excision of adenomyosis, reduced menorrhagia and dysmenorrhea, as well as the need for hysterectomy in patients with adenomyosis. Furthermore, according to a few studies, patients were able to achieve pregnancy after adenomyomectomy, suggesting that the surgery is a conservative and effective treatment method for adenomyosis. Considering these roles of uterus-sparing surgery with respect to the regulation of menstrual symptoms and fertility preservation, it could be postulated that maximal surgical reduction of adenomyotic tissue could be another treatment option for infertile patients with adenomyosis. <br />We modified previously reported conservative methods to facilitate effective reduction of adenomyotic lesions by including T- or transverse H-incision, utilization of an argon laser, sonographic measurement of the pathologic lesion during the operation, and a novel suture technique for uterine reconstruction. We intended to improve menstrual symptoms, increase pregnancy rate, and decrease obstetrical complications after maximal reduction of pathologic adenomyotic tissue while preserving endometrium and normal myometrial tissues. Uterus-sparing surgery appears to be an attractive option for treating adenomyosis and preserving fertility, but there is a paucity of well-designed prospective studies that assess fertility and pregnancy outcomes after surgery. <br />The objective of this study was to evaluate the clinical efficacy of this novel method of adenomyomectomy in infertile patients with severe adenomyosis via a well-designed prospective trial.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type /Procedure/Surgery  
Intervention Description Adenomyosis debulking surgery (adenomyomectomy): <br />We designed a novel operative procedure consisting of the following methods. First, an initial measurement of the adenomyotic lesion was made using ultrasonography and MRI. Then, a conventional laparotomy was prepared. To identify the endometrial cavity, a balloon uterine catheter was inserted into the endometrial cavity. After entering the peritoneal cavity and confirming the location of the adenomyosis, a ‘T’ or ‘transverse H’ incision was made on the adenomyotic wall to peel and preserve the serosa for later uterine reconstruction. The T-shaped incision was made as if peeling off the entire outer layer of the uterus. A transverse H-shaped incision was made in cases where there was a large lesion in the isthmus. <br />The adenomyotic region was wide and lacked clear boundaries; hence, the argon laser, rather than a scalpel, was used to peel off the adenomyotic tissue in a direction parallel to the endometrial plane. The entire adenomyotic lesion was not removed at once; rather, small amounts of the adenomyotic tissue, 2-3 mm thick, were shaved off with the argon laser several times. Throughout this step, the thickness of the residual myometrium was frequently measured using intraoperative ultrasonography. When the thickness of the residual myometrium was confirmed to be approximately 1 cm, no further excisions were made, and uterus reconstruction was initiated, even though some adenomyosis appeared to remain. <br />The absorbable suture was carefully used along the border between the serosal flap and residual myometrium to minimize dead space and hematoma formation. After the uterine serosa was closed, fixation suture (fixation of the serosal flap to the underlying myometrium to reduce the dead space) was applied. An adhesion-prevention barrier was applied on the uterine surface before closing the peritoneum.  
Number of Arms
Arm 1 Arm Label Infertilie women due to adenomyosis 
Target Number of Participant 50 
Arm Type Experimental 
Arm Description Adenomyosis debulking surgery (adenomyomectomy): We designed a novel operative procedure consisting of the following methods. First, an initial measurement of the adenomyotic lesion was made using ultrasonography and MRI. Then, a conventional laparotomy was prepared. To identify the endometrial cavity, a balloon uterine catheter was inserted into the endometrial cavity. After entering the peritoneal cavity and confirming the location of the adenomyosis, a ‘T’ or ‘transverse H’ incision was made on the adenomyotic wall to peel and preserve the serosa for later uterine reconstruction. The T-shaped incision was made as if peeling off the entire outer layer of the uterus. A transverse H-shaped incision was made in cases where there was a large lesion in the isthmus. The adenomyotic region was wide and lacked clear boundaries; hence, the argon laser, rather than a scalpel, was used to peel off the adenomyotic tissue in a direction parallel to the endometrial plane. The entire adenomyotic lesion was not removed at once; rather, small amounts of the adenomyotic tissue, 2-3 mm thick, were shaved off with the argon laser several times. Throughout this step, the thickness of the residual myometrium was frequently measured using intraoperative ultrasonography. When the thickness of the residual myometrium was confirmed to be approximately 1 cm, no further excisions were made, and uterus reconstruction was initiated, even though some adenomyosis appeared to remain. The absorbable suture was carefully used along the border between the serosal flap and residual myometrium to minimize dead space and hematoma formation. After the uterine serosa was closed, fixation suture (fixation of the serosal flap to the underlying myometrium to reduce the dead space) was applied. An adhesion-prevention barrier was applied on the uterine surface before closing the peritoneum. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of The genitoruinary system
 Adenomyosis
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 20 Year ~ 49 Year
Description 1. Patients diagnosed with adenomyosis via pelvic ultrasonography and magnetic resonance imaging (MRI) who had excessive menstrual flow and severe dysmenorrhea that disrupted daily life <br />2. Patients who had been diagnosed with primary or secondary infertility for more than a year, and their infertility was determined to be because of adenomyosis based on clinical assessments by an infertility exper <br />3. Patients who did not have any other medical conditions, excluding iron deficiency anaemia <br />4. Patients who failed to conceive after treatment with drugs, such as gonadotropin-releasing hormone agonist (GnRHa) <br />5. Infertile patients who had adenomyosis and other infertility factors, such as ovulation disorder and blocked fallopian tube,yet their implantation failure was determined to be because of adenomyosis after more than two failed attempts to conceive through IVF-ET and/or ovulation induction  
Exclusion Criteria 1. Patients with gynecologic malignancies such as cervical cancer or ovarian cancer <br />2. Patients with severe medical disease <br />3. Patients with active bacterial infection which needs parenteral antibiotics treatment <br />4. Patients who received pelvic irradiation due to malignancies <br />5. Patients with other severe medical disease <br />6. Patients with psychologic disorder <br />7. Patients who is impossible to participate in clinical trial by the law  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Pregnancy and its outcome 
Timepoint Follow-up 3 months interval from 6 months after the operation 
Secondary Outcome(s) 1 
Outcome Dysmenorrhea and menorrhagia 
Timepoint Follow-up 3 months interval from 6 months after the operation 

11. Study Results and Publication

Study Results and Publication Information
Result Registered Yes
Results Upload
Final Enrollment Number 50
Number of Publication
Results Upload 연구결과 파일저장 Results Donwload  
Date of Posting Results 2019-07-11
Protocol URL or File Upload  
Brief Summary The mean age and the duration of infertility were 35.60 ± 3.33 years and 55.48 ± 48.24 months, respectively. The mean weight of excised specimens of adenomyosis was 94.15 ± 56.63 g. Relief of dysmenorrhea was observed clearly in all patients at 6 months postoperatively (numeric rating scale; 7.28 ± 2.30 vs. 1.56 ± 1.30, P &lt; 0.001). The amount of menstrual blood significantly decreased (140.44 ± 91.68 vs. 66.33 ± 65.85 mL, P &lt; 0.05). The cancer antigen 125 (CA 125) level also significantly decreased at 6 months postoperatively (187.75 ± 221.13 vs. 20.78 ± 19.28 IU/mL, P &lt; 0.05). Postoperative complications occurred in four patients (uterine shrinkage, premature ovarian insufficiency, ureter fistula, and subfascial hematoma). Of 33 patients who attempted pregnancy, 18 (54.5%) conceived by natural pregnancy, IVF-ET, or thawing ET postoperatively; miscarriage occurred in 8 patients while 10 (30.3%) patients had viable pregnancies. The number of live births was 13; two patients had twin pregnancies, and one patient delivered twice. There were two preterm deliveries among 11 viable pregnancies. There was no uterine rupture or caesarean hysterectomy.  

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2020.01
Way of Sharing Available on Request
(Ju-Won Roh (rohjuwon@hanmail.net))
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