Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000899549
Ethics application status
Approved
Date submitted
20/05/2015
Date registered
27/08/2015
Date last updated
27/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Performance and complications of hysteroscopic adhesiolysis of in women complaining of reproductive failure due to intrauterine adhesions.
Scientific title
Efficacy and safety of hysteroscopic adhesiolysis in women with intra-uterine adhesions who are trying to become pregnant
Secondary ID [1] 286758 0
Nil
Universal Trial Number (UTN)
U1111-1170-3308
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intrauterine adhesions 295128 0
Condition category
Condition code
Reproductive Health and Childbirth 295370 295370 0 0
Fertility including in vitro fertilisation
Surgery 295745 295745 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hysteroscopy is the method of choice to diagnose, treat and follow up patients with intrauterine adhesions.
steps of hysteroscopic adhesiolysis: the procedure was carried out with senior gynaecological endoscopist. The cervix was dilated to Hegar dilator 6. A forward oblique 30 degree, hysteroscopy was inserted inside the uterine cavity that was distended with 0.9% normal saline at inflow pressure of 60–90 mmHg, using a special machine, hysterometer, which was used to adjust the pressure of the flow, the amount of the distension media fluid used and the deficit after the operation.
The operative hysteroscopy used was 5.5 mm outer sheath diameter that permits the use of 3-5 French diameter semi-rigid scissors to lyse the adhesion at the junction of the adhesion with the endometrium and excise the tissue.
Duration of hysteroscopy procedure was ranged between 10 – 52minutes with average time was 29 minutes.
Intervention code [1] 291913 0
Treatment: Surgery
Intervention code [2] 292119 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295110 0
pregnancy rate. It was assessed during routine follow up from patients records in endoscopy unit in our hospital.
Timepoint [1] 295110 0
6 months postoperative.
Primary outcome [2] 295570 0
Duration of pregnancies. It was assessed during routine follow up from patients records in antenatal care clinic in our hospital.
Timepoint [2] 295570 0
If pregnancy occurred during 6 months postoperative; the follow up period extended from the diagnosis of pregnancy till the time of birth or termination of pregnancy.
Primary outcome [3] 295571 0
live births rate. It was assessed during routine follow up from patients records in labor ward department in our hospital.
Timepoint [3] 295571 0
If pregnancy occurred during 6 months postoperative; the follow up period extended till the time of birth or termination of pregnancy.
Secondary outcome [1] 314790 0
Composite outcome of number of bleeding days and amount of menstrual blood loss. i.e. the changes in postoperative menstrual pattern. These changes will be assessed by clinical follow up. The patients will be asked about number of bleeding days, number of napkins per day and the degree of soakness using pictoria charts.
Timepoint [1] 314790 0
6 months postoperative
Secondary outcome [2] 314791 0
The need for another hysteroscopic trial for adhesiolysis. The need for another hysteroscopic procedure will be assessed by using hysterosalpingogram and office hysteroscopy.
Timepoint [2] 314791 0
6 months post operative
Secondary outcome [3] 315372 0
Intra- and postoperative complications, like pain, fever, bleeding, postoperative adhesions, theses parameters will be assessed by clinical follow up
Timepoint [3] 315372 0
intraoperative complication assessed during the operative procedure. Early postoperative follow up within first 24 days. late postoperative complications within month.
Secondary outcome [4] 316546 0
time lag between the intervention and diagnosis of pregnancy
Timepoint [4] 316546 0
During the first 6 months postoperative. If pregnancy occurred the follow up period was extended till the day of delivery or termination of pregnancy

Eligibility
Key inclusion criteria
Patients trying to get pregnant with intra-uterine adhesions that affect their reproductive carrier, with no contraindication for either pregnancy or surgery
Minimum age
18 Years
Maximum age
37 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age more than 37 years old, other causes of amenorrhea or reproductive failure as ovulatory disorder, tubal block, pelvic adhesions diagnosed by laparoscopy, PID or male factors of infertility.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Menstrual and fertility outcomes data were statistically described in terms of range, mean +/- standard deviation (+/-SD), median, frequencies (number of cases) and relative frequencies (percentages) when appropriate. Comparison of quantitative variables between different groups in the present study was done using Mann Whitney U test for independent samples. For comparing categorical data, Chi square test was performed. Exact test was used instead when the expected frequency is less than 5. Accuracy was represented using the terms sensitivity and specificity.
Correlation between various variables were done using Pearson moment correlation and Spearman rank correlation equations. A probability values (p value) less than 0.05 were considered statistically significant.
All statistical calculations were done using computer programs Microsoft Excel version 7 (Microsoft Corporation, NY, USA), SPSS (Statistical Package for the Social Science; SPSS; Inc., Chicago, IL, USA version 20) and Arcus Quick Stat (Biomedical version, Addison Wesley Longman Ltd, USA) statistical-program. The number of participants was not determined by sample size equation as it is not controlled trial nor diagnostic one.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
1/02/2009
Date of last participant enrolment
Anticipated
31/01/2013
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 6889 0
Egypt
State/province [1] 6889 0
Minia

Funding & Sponsors
Funding source category [1] 291301 0
Hospital
Name [1] 291301 0
Minia Maternity University Hospital
Country [1] 291301 0
Egypt
Primary sponsor type
Hospital
Name
Minia Maternity University Hospital
Address
Minia- Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia Governorate, Postal code: 61111
Country
Egypt
Secondary sponsor category [1] 289984 0
None
Name [1] 289984 0
Address [1] 289984 0
Country [1] 289984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292868 0
Scientific ethical committee of the department of Obstetrics and Gynecology
Ethics committee address [1] 292868 0
Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia Governorate, postal code: 61111
Ethics committee country [1] 292868 0
Egypt
Date submitted for ethics approval [1] 292868 0
01/10/2008
Approval date [1] 292868 0
15/12/2008
Ethics approval number [1] 292868 0
Ethics committee name [2] 293031 0
Institutional Review Board of the University Hospital-Quality control unit of the Faculty of Medicine, Minia University
Ethics committee address [2] 293031 0
Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia Governorate, postal code: 61111
Ethics committee country [2] 293031 0
Egypt
Date submitted for ethics approval [2] 293031 0
01/12/2008
Approval date [2] 293031 0
01/12/2008
Ethics approval number [2] 293031 0

Summary
Brief summary
This study aimed to assess the efficacy and safety of hysteroscopic adhesiolysis in patients with bad obstetric outcome due to intrauterine adhesions.
Trial website
no
Trial related presentations / publications
no
Public notes
no

Contacts
Principal investigator
Name 57426 0
A/Prof Ahmad Sameer Sanad
Address 57426 0
Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia Governorate, postal code: 61111
Country 57426 0
Egypt
Phone 57426 0
+20 01000222994
Fax 57426 0
Email 57426 0
[email protected]
Contact person for public queries
Name 57427 0
A/Prof Ahmad Sameer Sanad
Address 57427 0
Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia Governorate, postal code:61111
Country 57427 0
Egypt
Phone 57427 0
+20 01000222994
Fax 57427 0
Email 57427 0
[email protected]
Contact person for scientific queries
Name 57428 0
A/Prof Ahmad Sameer Sanad
Address 57428 0
Minia Maternity University Hospital, Cornish El- Nile Street, Minia Minia, postal code:61111
Country 57428 0
Egypt
Phone 57428 0
+20 01000222994
Fax 57428 0
Email 57428 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.