Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810634381311 Date of Approval: 30/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intracystic injection of methotrxate in postmenopausal female suffering from simple ovarian cyst with low malignancy index .
Official scientific title Intracystic injection of methotrxate in postmenopausal female suffering from simple ovarian cyst with low malignancy index .
Brief summary describing the background and objectives of the trial Aim: To evaluate technique of intracystic injection of methotrxate in postmenopausal female suffering from simple ovarian cyst with low malignancy index Design: clinical randomized controlled study. method : two groups of patients , with postmenopaual ovarian cyst with low ,maliganancy index , study group will be subjected to ultrasonic guided aspiration of the cyst followed by intracystic injection of methotrxate , control group will be subjected to only follow up Outcome: Recurrence of the cyst.,Change in the cyst size.,Occurrence of complications related to the cyst ( rupture , heamorrahge…) ,Appearance of a new symptoms ,Need of other surgical interference like exploration ,Post operative complication : like postoperative pain , postoperative sepsis ,
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied postmenopausal ovarain cyst
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2018
Actual trial start date
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group methotrxate group 3 ml of normal saline was added to one ampoule of methotrexate 50 mg and then injected inside cyst cavity under ultrasonic guidance 6 months follow up 1. Preoperative all patients will be examined for the exclusion of vaginal infection. 2. The patient will be positioned in lithotomy position 3. Chlorhexidine will be used for Vaginal cleansing . 4. The needle used 16-gauge, 35cm long, attached to transvaginal probe (Samsung Medison.UGEO H60; Korea). 5. The transvaginal transducer will be attached to needle guide introduced into the vagina 6. The needle will be introduced through needle guide; it is course will be noticed in the screen. Till it seen inside the cyst . a syringe will be connected to the needle 7. Aspiration of the content of the cyst will be done using negative pressure .and the cyst will be completely evacuated. 8. We will make sure that the cyst is completely evacuated and no signs of internal hemorrhage by transvaginal ultrasound. 9. Cyst contents will be sent for bacteriological and cytological examination. 10. While the needle is inside the cyst , 3 ml of normal saline was added to one ampoule of methotrexate 50 mg and then injected inside cyst cavity under ultrasonic guidance 11. Postoperative follow up of patient for pain and fever for 24 hours , then ultrasound will be done to the patient before discharge , and appropriate antibiotic will be given to the patient. 12. Follow up of the patient will be done after 3 months and 6 months interval for the recurrence of the lesion 25
Control Group follow up group follow up only 6 months 1- No interference 2- Follow up of the patient will be done after 3 months and 6 months interval for the recurrence of the lesion 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Postmenopausal female 2- Simple ovarian cyst 3- Calculated malignancy index is less than 25 ( low malignancy index) 1- Medical disorders like liver disease or renal disease 2- Known to have allergy to methotrexate 3- Her blood picture shows low leucocytes count 4- She had previous pelvic surgery with rising suspicious of presence old dense pelvic adhesions 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 100 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2018 research ethicas committee tanat university faculty of medecine
Ethics Committee Address
Street address City Postal code Country
elgiesh street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Recurrence of the cyst. 3 months
Secondary Outcome Change in the cyst size. • Occurrence of complications related to the cyst ( rupture , heamorrahge…) • Appearance of a new symptoms • Need of other surgical interference like exploration • Post operative complication : like postoperative pain , postoperative sepsis , 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital elgiesh street tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta university hospital elgiesh street tanta 31527 Egypt
self funded elrefaee street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university elgiesh tanat 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
amal elsokary elrefaae street tanat Egypt
ahemd elkhyat lexandria square tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amal elsokary amalelsokary81@gmail.com 0201000653879 elrefaae street
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of obesterics and gynecology
Role Name Email Phone Street address
Public Enquiries ahmed elkhyat ahmedelkhyat81@gmail.com 0201007981804 alexandria square
City Postal code Country Position/Affiliation
tanta Egypt lecturer of obesterics and gynecology
Role Name Email Phone Street address
Scientific Enquiries shereef elshwaikh elshwaikh frommetou35@gmail.com 02012221561506 darelsalam street
City Postal code Country Position/Affiliation
tanta Egypt lecturer of obesterics and gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information