Evaluation of human amniotic membrane on reducing post-surgical adhesions

Investigating the effect of human amniotic membrane on reducing adhesions after laparoscopic endometriosis surgery

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3, on 40 patients, A random table of numbers between 0 and 1 will be used for randomization.

Based on the block randomization list, candidates patients for advanced endometriosis laparoscopy are selected randomly at Arash Women's Hospital. After obtaining full informed consent and a full explanation about the need for second look surgery and the use of the new and cheap hAM anti-adhesion method, in this study we place a dry patch of amniotic membrane at the adhesion site during laparoscopic surgery. And the adhesion will be checked in both groups 3 months later by ultrasound and second look surgery.

Inclusion: trans vaginal/rectal US of deep endometriosis, candidate for endometriosis surgical treatment, age 18-45 years, no conception desire Exclusion: no consent to continue participating in the study, presence of active infection, pregnancy and breastfeeding,genital inflammations, cardiovascular, gastrointestinal, hormonal problems, autoimmune such as lupus, etc. Cancer in the past and present, positive serulogic evidence regarding previous or current hepatitis B and C, HIV, HTLV

After full informed consent and a full explanation new and cheap hAM anti-adhesion method, in this study we place a dry patch of amniotic membrane at the adhesion site during laparoscopic surgery in the case group and not to put in control group. The adhesion will be checked 3 months later by US and second look surgery

Adhesion

A simple randomization method will be used. A random table of numbers between 0 and 1 will be created and each of the research participants will be placed in the intervention group if the number is between 0 and 0.5 and in the control group if the number is between 0.51 and 1.

participants Clinic nurse radiologist Review surgeon Data analyst The method of hiding the randomization process of the list of random allocation of patients was only at the disposal of the nurse of the laparoscopy clinic. In order to hide the random allocation process, the sequence of treatments was written on the cards in order, then the cards were placed in sealed envelopes. A random 10-digit code was written on each envelope without any order or framework, which was the identification number of the relevant patient and only the project methodologist was aware of the relevant code. When the doctor announced the eligibility of a patient, the nurse provided the envelope to the doctor and the desired treatment was carried out based on the type mentioned in the envelope. And the review of the study results was completed by the doctor who was unaware of the type of intervention. Due to the type of treatment, patients will know the type of intervention.

According to the researchers, the data that does not endanger the confidentiality of the patient and has the approval of the ethics committee and the relevant officials can be presented.

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