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Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. The investigators have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair. Postoperative menstruation may contribute to surgical site infections, which may subsequently affect the healing of uterine scars. Treatment CSD patients with gonadotropin-releasing hormone agonist (GnRHa) may has the potential to improve therapeutic effects of vaginal repair. Therefore, the current multiple-center randomized controlled trial was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
Postoperative menstruation may contribute to surgical site infections, an inflammatory environment, congestion at the site of the suture, immune cell infiltration, and other effects and may subsequently affect the healing of uterine scars. It is reasonable to hypothesize that delaying the postoperative menstrual recovery period may allow uterine scars to heal without the inflammatory reaction caused by menstruation. Treatment with gonadotropin-releasing hormone agonist (GnRHa) has the ability to suppress follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release, thereby maintaining low estrogen levels and causing temporary amenorrhea. A prolonged menstrual recovery period may be achieved after GnRHa administration. Vaginal repair of CSD combined with GnRHa may improve the therapeutic effects of treatment of CSD. Therefore, the randomized study was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR + GnRHa | Experimental | CSD patients were treated with vaginal repair of CSD in combination with GnRHa (Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom) as a subcutaneous injection (abbreviated as VR + GnRHa). In the group of VR + GnRHa, 2 doses of GnRHa were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016). |
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| VR | Placebo Comparator | CSD patients were treated with vaginal repair of CSD in combination with 0.01 ml saline as a subcutaneous injection (abbreviated as VR). In the group of VR, 2 doses of saline were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRHa | Drug | Two doses of GnRHa were administered by subcutaneous injection. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| thickness of the remaining muscular layer (mm) | The thickness of the remaining muscular layer is measured by transvaginal ultrasound. | 6 months after vaginal repair of CSD |
| duration of menstruation (day) | The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD. | 6 months after vaginal repair of CSD |
| Measure | Description | Time Frame |
|---|---|---|
| the length of CSD (mm) | The length of CSD is measured by transvaginal ultrasound. | 6 months after vaginal repair of CSD |
| the width of CSD (mm) | The width of CSD is measured by transvaginal ultrasound. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xipeng Wang, M.D., Ph.D., | Contact | 86-13817806602 | xipengwang@hotmail.com | |
| Xiaoqian Yang, M.D., Ph.D., | Contact | 86-18516703569 | yangxiaoqian1986@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xipeng Wang, M.D., Ph.D., | Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University | Shanghai | Shanghai Municipality | 201204 | China |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Vaginal repair of CSD | Procedure | The procedure of vaginal repair of CSD was shown as following. The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached. The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed. A double layer of 1-0 absorbable interrupted sutures was used to close the incisions. |
|
| 6 months after vaginal repair of CSD |
| the depth of CSD (mm) | The depth of CSD is measured by transvaginal ultrasound. | 6 months after vaginal repair of CSD |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |