]>
IRCT20160527028109N3 IRCT 2021-04-26 Iran University of Medical Sciences Safety and efficacy of ovarian lifting and immobilization during laparoscopic cystectomy Safety and efficacy of ovarian suspension loop: an assembled device for ovarian lifting and immobilization during laparoscopic cystectomy 2021-04-21 anticipated 30 Complete https://irct.ir/trial/55266 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation in this study is limited to intervention and control groups using randomization. Random allocation law is the simplest and most limited method of randomization. This method represents a large block for the total sample size. For this purpose, the researchers first determine a total sample size and then randomly divide a set of them into groups A and B. For example, in this study with a sample size of 26 people. 13 balls for intervention group A and 13 balls for intervention group B are placed inside a lottery container and then the balls are randomly removed from the container and a sequence is created. This method is used for two- or multi-group experiments, Blinding description: The outcome assessor and data analyst will not know how the groups are assigned. But because patients' consent must be obtained, the patient knows in which group. For this purpose, before random allocation, a complete explanation of the interventions is given and the patient is told that they will be randomly placed in one of the groups. N/A Reduce surgical time. Intervention 1: Intervention group: Women with ovarian cysts, in which ovarian loops are used during laparoscopic surgery. To assemble the ovary suspension ring, depending on the thickness of the abdominal wall, about 25-35 cm of nylon suture is cut and also, depending on the length of the mesarium, about 8 to 12 cm is cut from the scalp vein catheter tube. The nylon thread is then passed through the scalp vein catheter and tied to create a loop at both ends. The node can be placed inside the catheter to hide. The assembled device is guided through one of the laparoscopic portals to the pelvic cavity and under the camera, along with the mapping of the abdominal surface, to the best point of placement of the ovarian cyst. The facial clouser is then inserted and the nylon thread is guided to the jaw. The facial clouser is pulled out of the abdomen and held in place by the Kelly clamp to prevent it from slipping back into the abdomen. The two ends of the tube catheter are taken with two graspers and guided under the ovary containing the cyst, and after ensuring the correct placement, the amount of lifting with Kelly is guided out of the abdomen and fixed. It should be noted that excessive stretching causes impaired blood flow to the ovaries, so excessive tension should be avoided and a cystectomy can be performed. Intervention 2: Control group: Women with ovarian cysts, in which ovarian loops aren't used during laparoscopic surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Kobra Tahermanesh
Rasoul Akram Hospital, Satarkhan St, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 64351 tahermanesh.k@iums.ac.ir Iran University of Medical Sciences scientific Kobra Tahermanesh
Rasoul Akram Hospital, Satarkhan St, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 64351 tahermanesh.k@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Premenopausal women women with ovarian cyst no limit no limit Female unwillingness to cooperate at the study Treatment - Surgery Treatment - Surgery Intervention group: Women with ovarian cysts, in which ovarian loops are used during laparoscopic surgery. To assemble the ovary suspension ring, depending on the thickness of the abdominal wall, about 25-35 cm of nylon suture is cut and also, depending on the length of the mesarium, about 8 to 12 cm is cut from the scalp vein catheter tube. The nylon thread is then passed through the scalp vein catheter and tied to create a loop at both ends. The node can be placed inside the catheter to hide. The assembled device is guided through one of the laparoscopic portals to the pelvic cavity and under the camera, along with the mapping of the abdominal surface, to the best point of placement of the ovarian cyst. The facial clouser is then inserted and the nylon thread is guided to the jaw. The facial clouser is pulled out of the abdomen and held in place by the Kelly clamp to prevent it from slipping back into the abdomen. The two ends of the tube catheter are taken with two graspers and guided under the ovary containing the cyst, and after ensuring the correct placement, the amount of lifting with Kelly is guided out of the abdomen and fixed. It should be noted that excessive stretching causes impaired blood flow to the ovaries, so excessive tension should be avoided and a cystectomy can be performed. Control group: Women with ovarian cysts, in which ovarian loops aren't used during laparoscopic surgery. How long it takes for an ovarian cyst to come out. Timepoint: During the surgery. Method of measurement: Chronometer. Iran University of Medical Sciences Approved 2020-11-11 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)