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出境医 / 临床实验 / Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Study Description
Brief Summary:
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

Condition or disease Intervention/treatment Phase
Submucous Leiomyoma of Uterus Drug: Misoprostol Drug: Vasopressin Phase 2 Phase 3

Detailed Description:
This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : March 15, 2017
Arms and Interventions
Arm Intervention/treatment
Active Comparator: misoprostol group
20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
 Drug: Misoprostol
prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
Other Name: Misotac
Active Comparator: vasopressin group
20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
 Drug: Vasopressin
one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
Outcome Measures
Primary Outcome Measures :
  1. intraoperative bleeding [ Time Frame: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure ]
    subjective assessment of bleeding by the surgeon.

  2. operative time [ Time Frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure ]
    time needed for completion of myomectomy procedure

  3. haemoglobin and hematocrit deficit [ Time Frame: 24 hours before myomectomy and 24 hour after myomectomy ]
    haemoglobin and hematocrit values before and after myomectomy


Secondary Outcome Measures :
  1. Degree of visual clarity [ Time Frame: start with the first resectoscope myoma cut till the completion of myoma resection ]
    visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)

  2. Fluid deficit [ Time Frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure ]
    calculation the fluid deficit between in flow volume and outflow volume

  3. time need for cervical dilatation [ Time Frame: start from grasping the cervix till insertion of hysterescope ]
    time needed to dilate the cervix to admit the operative hysterescope


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
  • grade 0 and grade 1 submucous myomas
  • less than 5 centimeters in diameter

Exclusion Criteria:

  • Patients with grade 2 submucous myoma or more
  • patients with submucous myomas larger than 5 cm in diameter
  • postmenopausal women
  • patients received GnRh analogue in last 6 months
  • patients with anticoagulant therapy
  • patients with endometrial premalignant or malignant pathologies
  • patients with cardiovascular diseases, asthma or impaired kidney functions
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE May 2, 2016
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • intraoperative bleeding [ Time Frame: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure ]
    subjective assessment of bleeding by the surgeon.
  • operative time [ Time Frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure ]
    time needed for completion of myomectomy procedure
  • haemoglobin and hematocrit deficit [ Time Frame: 24 hours before myomectomy and 24 hour after myomectomy ]
    haemoglobin and hematocrit values before and after myomectomy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Degree of visual clarity [ Time Frame: start with the first resectoscope myoma cut till the completion of myoma resection ]
    visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)
  • Fluid deficit [ Time Frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure ]
    calculation the fluid deficit between in flow volume and outflow volume
  • time need for cervical dilatation [ Time Frame: start from grasping the cervix till insertion of hysterescope ]
    time needed to dilate the cervix to admit the operative hysterescope
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Official Title  ICMJE Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
Brief Summary A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .
Detailed Description This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Submucous Leiomyoma of Uterus
Intervention  ICMJE
  • Drug: Misoprostol
    prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
    Other Name: Misotac
  • Drug: Vasopressin
    one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
Study Arms  ICMJE
  • Active Comparator: misoprostol group
    20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
    Intervention: Drug: Misoprostol
  • Active Comparator: vasopressin group
    20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
    Intervention: Drug: Vasopressin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019) 		40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2017
Actual Primary Completion Date January 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
  • grade 0 and grade 1 submucous myomas
  • less than 5 centimeters in diameter

Exclusion Criteria:

  • Patients with grade 2 submucous myoma or more
  • patients with submucous myomas larger than 5 cm in diameter
  • postmenopausal women
  • patients received GnRh analogue in last 6 months
  • patients with anticoagulant therapy
  • patients with endometrial premalignant or malignant pathologies
  • patients with cardiovascular diseases, asthma or impaired kidney functions
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930069
Other Study ID Numbers  ICMJE Hysterscopioc myomectomy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hossam mohamed, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zagazig University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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