Investigating the success rate of using human acellular tissue in reconstructive surgeries in women with anterior or apical pelvic prolapse

Investigation of human cellular tissue in reconstructive surgeries of female pelvic floor prolapse

Preparation of acellularization will be done in the laboratory. A sample of the tissues will be prepared for photography and then the samples will be packed (the original tissue and several tissues in the sizes small to perform sterilization confirmation tests) and for dosimetry and irradiation and sterilization test after irradiation will be sent to the Atomic Energy Organization to ensure the sterility of the samples. After irradiation, the tissues will be photographed again to make sure that the scaffold is not destroyed and that the samples are acellular. To ensure complete sterilization of the samples after sterilization by atomic energy, all mycological, microbial, mycoplasma, HIV, HBV, HCV, CMV, EBV, HTLV tests will be performed. During the operation to repair the anterior and apical compartments, the patients are randomly divided into case and control groups. In the case group, a scaffold is used for repair, while in the control group, the repair is done with the person's own tissue.A computerized randomization list, generated by an independent statistician blinded to the trial and unrelated to the subjects involved, will use 1:1 allocation.

Surgeries are performed in the operating room of Imam Hospital. Patients are blinded to intervention allocation.

Women over 18 years old with anterior and apical compartment prolapse stage 2 and above and candidates for reconstructive surgery

The use of human acellular tissue for repair, which is sterilized in special laboratory conditions and is used for repair in sterile conditions in the operating room.

The absence of prolapse beyond the hymen in any compartment with the standard measurement system of pelvic organ prolapse

A computerized randomization list, generated by an independent statistician blinded to the trial and unrelated to the subjects involved, will use 1:1 allocation. All participants are blinded to the list. The randomization list will be administered using identical, sequentially numbered study drug containers, and these containers will be identically labeled by two investigators who will not be involved in the recruitment of study subjects. The block random assignment method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6. AAABBB-AABBAB-ABBBAA-AABABB-

Participants are blinded to the type of intervention. Before the study, the candidates have been given complete information about the allocation of groups. The researcher is not blind to the groups The analyst is also blind to the groups and the data for analysis is delivered to him in coded form without mentioning the type of intervention.