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IRCT20091012002576N27 IRCT 2023-01-27 Tehran University of Medical Sciences Efficacy of vasopressin for adhisionolysis of bowel DIE in laparoscopy Comparison the efficacy of vasopressin injection for adhisionolysis of bowel DIE (deep infilterating endometriosis)in laparoscopic surgery for severe endometriosis 2023-01-30 anticipated 100 Complete https://irct.ir/trial/65198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After randomization 100 patients randomly will assigned in intervention group who wii received diluted injection vasopressin in 200 cc normal salin in low posterior wall of uterus, or control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded. 50 letters A and 50 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patients. In addition, interventions A (case group) or B (control group) are determined by a lot, Blinding description: This is a double blind intervention which patients and physician are blinded regarding groups. Patients and care providers are blinded regarding the case and control groups with using saline that is the same as vasopressin regarding the appearance. 3 Severe endometriosis. Intervention 1: Intervention group: In intervention group 50 patients will allocated and diluted injection vasopressin in 200 cc normal salin will injected in low posterior wall of uterus. Bleeding, ease of adhesion dissection, surgical complications will be recorded. Intervention 2: Control group: 5o patients randomly will assigned in control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded. Yes - There is a plan to make this available What will be shared: The data are available by mail When: SPSS data after publishing data till 3 years To whom: Academic Researchers Conditions: For scientific purpose Where to obtain: Mail to:fatedavtanha @gmail.com How to obtain: Two weeks after email the data will be available. Comments:
public Fatemeh Davari Tanha
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8831 3955 fdavaritanha@sina.tums.ac.ir Tehran University of Medical Sciences scientific Fatemeh Davari Tanha
Yas hospital, North Ostad Nejatollahi Avenue, Karim khan Zand Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8831 3955 fdavaritanha@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 20-50 Stage 3-4 endometriosis according to ASRM Severe adhesion in pelvis 20 years 50 years Female Hypersensitivity to vasopressin Endocrine disease N97.8 Treatment - Surgery Treatment - Surgery Intervention group: In intervention group 50 patients will allocated and diluted injection vasopressin in 200 cc normal salin will injected in low posterior wall of uterus. Bleeding, ease of adhesion dissection, surgical complications will be recorded. Control group: 5o patients randomly will assigned in control group who received injection of normal salin in the site of adhesion. Bleeding, ease of adhesion dissection, surgical complications will be recorded. Time of surgery,Bleeding,bowel injury, ease of dissection. Timepoint: After surgery. Method of measurement: Questionnaire. Dysmenorrhoea, dysparunia,chemical pregnancy, clinical pregnancy. Timepoint: 3-6 months after surgery. Method of measurement: Questionnaire,bhcg test. Tehran University of Medical Sciences Approved 2023-01-23 Ethic committee of Tehran University of medical sciences Deputy of research, sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)