Assessment of the effect of N-acetylcysteine drug and oral contraceptive pills on chronic pelvic pain and sonographic endometrioma recurrence rate after laparoscopic surgery in patients with endometrioma
Assessment of the effect of N-acetylcysteine drug and oral contraceptive pill on chronic pelvic pain and sonographic endometrioma recurrence rate after laparoscopic surgery in patients with endometrioma
Design
Clinical trial with control group, with parallel groups, double-blind, randomized with a sample size of 112
Settings and conduct
This study was performed in the laparoscopy center of Arash Women's Hospital (affiliated to Tehran University of Medical Sciences) on eligible women who were consented to participate in the study.
The outcome assessor and the statistician were unaware of the randomization and interventions performed in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate for laparoscopic surgery for endometrioma; Presence of at least one documented endometrioma in two ultrasound findings. Non-inclusion criteria: Usual contraindications to Estrogens and Progestins; Women's desire to get pregnant after surgery
Intervention groups
Intervention group: Take one 600 mg effervescent N-acetylcysteine tablet three times a day(three times a week)for 3 months plus one oral contraceptive pill continuously used for 6 months.
Control group: Use only one oral contraceptive per day continuously for 6 months
Main outcome variables
Endometrioma recurrence; Pelvic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N11
Registration date:2019-11-15, 1398/08/24
Registration timing:retrospective
Last update:2019-11-15, 1398/08/24
Update count:0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of N-acetylcysteine drug and oral contraceptive pills on chronic pelvic pain and sonographic endometrioma recurrence rate after laparoscopic surgery in patients with endometrioma
Public title
Effect of N-acetylcysteine drug and oral contraceptive pill on chronic pelvic pain and endometrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for endometrioma laparoscopy surgery
Presence of at least one documented endometrioma in two ultrasound findings
Exclusion criteria:
Patient who desire to become pregnant after surgery
Usual contraindications to estrogens and progestins
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size was 112participants (56 people in each group). The block randomization method was developed by epidemiologist collaborator using version 13 of Stata software. The number of blocks considered is 6.
To conceal the random allocation process, 112treatment cards were written in sequential order, then the cards were placed in sealed envelopes. On each envelope, a random code was written with no sequences that only the methodologist was aware of the code. When the physician announced a patient's eligibility, the methodologist provided the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who evaluated the final outcomes was unaware of the random allocation process and the type of treatment performed. Data were analyzed by a statistical expert who was separated from the study process and unaware of all the processes performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Vice-Chancellor in Research, Tehran University of Medical Science,near Qods st, keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1724
Health conditions studied
1
Description of health condition studied
endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
recurrence of endometrioma
Timepoint
3 and 6 months after intervention
Method of measurement
sonography
2
Description
Chronic pelvic pain
Timepoint
Before surgery and3 and 6 months after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive 6 months continuous OCPin addition to 3 months N Acetylcysteine (OSVEH, Iran) according to the following schedule: effervescent tablets of N acetylcysteine 600 mg three times A day, three consecutive days a week
Category
Treatment - Drugs
2
Description
control group: receive an oral contraceptive pill a day for 6 months continuously