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IRCT20130826014483N11 IRCT 2022-12-14 Mazandaran University of Medical Sciences Comparison between Postanal Repair and levatorplasty in Treatment of Rectal Prolapse Comparison of outcomes between Postanal Repair and levatorplasty in Treatment of Rectal Prolapse 2022-02-04 anticipated 40 Complete https://irct.ir/trial/67217 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After applying the entry and exit criteria, subjects will be randomly assigned using permutation blocks. By using Sealedenvelop.com software, a sequence of size 80 will be produced. The randomization unit is an individual. The size of the blocks is 4 and in each block each intervention group will be repeated twice (the randomization ratio in each block is 1:1). Using this randomly generated list, the participants are assigned to one of the two study groups. In order to hide the list of random allocation, a special code will be assigned to each of the intervention groups, which even the main implementer of the project (supervisor) is not aware of. These codes are written on a paper and placed inside a sealed envelope. A unique code specific to each patient will be written on this paper and its envelope. All envelopes will be placed in a larger box in random order and sealed in the box. The main researcher, after reviewing the criteria for entering the study and obtaining informed consent, as well as registering the patient's profile in a special form, in collaboration with the random allocation list (this person is an expert, other than the main researcher, who is involved in the patient recruitment process and sample entry) is called and randomization of that patient is done, Blinding description: The study is blinded from the point of view of the patients and the evaluator, and the patient and the evaluator are not aware of the results and complications after the operation of the groups, but the surgeon knows. This study is double blind. N/A Rectal prolapse. Intervention 1: Intervention group: Before the operation, prophylactic antibiotics and laxatives are prescribed for the patients to keep the intestines clean. Eltmeyer surgery is a procedure in which the part of the rectum protruding from the anal canal is resected and the remaining two ends of the intestine are anastomosed to each other. 2 mg of fentanyl and midazolam were used for anesthesia and 3 to 5 mg/kg sodium thiopental was used to induce anesthesia, then intubation was performed, then anesthesia was continued with 3% isoflurane. The patients are placed in the lithotomy position, the prolapsed rectum is pulled out towards the perineum with the help of a retractor, then the intestinal mucosa is cut circularly 1-2 cm above the dentate line, when separating the muscle layer, the homeostasis of the submucosa layer is ensured. Then the rectum is pulled down to reveal the rectovaginal peritoneal fold. At this time, the peritoneum is opened from the anterior and lateral parts until the sigmoid colon is pulled down and the location of the intestinal tract is determined. The sigmoid mesentery is also separated and ligated. An incision is made in the anterior part of the sigmoid colon, here the first anastomotic sutures are created, then the same is done for the lateral and posterior parts of the sigmoid colon. Colon-anal anastomosis is reinforced with multiple sutures. Anastomosis can be performed with the help of a circular stapler depending on the conditions and decision of the surgeon. In order to repair the pelvic floor (levatorplasty) after the mesorectal dissection, the posterior wall of the vagina is dissected along with the fat tissue of the Douglas pouch so that the slings of the levator ani muscles appear. The sutures are pulled up from the peritoneum to the anterior wall of the sigmoid pouch of Douglas, and finally, the two arms of the levator ani muscle are connected in the midline and in front of the intestine with previous sutures, and the gap created in the pelvic diaphragm is repaired with anterior levatoroplasty. . This repair is usually done based on the surgeon's judgment during the operation for patients with narrow and weak levatorian muscles. Intervention 2: Control group: A group in which post-anal repair surgery and levatoroplasty are not performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr.Mina Alvandipour
Amirmazandarani St, Sari
Sari Iran (Islamic Republic of) 33131 – 48166 +98 11 3336 1700 malvandipour@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr.Mina Alvandipour
Amirmazandarani St, Sari
Sari Iran (Islamic Republic of) 33131 – 48166 +98 11 3336 1700 malvandipour@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 80 years old Patients who have consented to the implementation of the study Patients who are candidates for Altemeier restoration 18 years 80 years Both Patients who did not consent to participate in the study Patients who are candidates for rectal prolapse repair with other methods K62.3 Rectal prolapse Treatment - Surgery Treatment - Surgery Intervention group: Before the operation, prophylactic antibiotics and laxatives are prescribed for the patients to keep the intestines clean. Eltmeyer surgery is a procedure in which the part of the rectum protruding from the anal canal is resected and the remaining two ends of the intestine are anastomosed to each other. 2 mg of fentanyl and midazolam were used for anesthesia and 3 to 5 mg/kg sodium thiopental was used to induce anesthesia, then intubation was performed, then anesthesia was continued with 3% isoflurane. The patients are placed in the lithotomy position, the prolapsed rectum is pulled out towards the perineum with the help of a retractor, then the intestinal mucosa is cut circularly 1-2 cm above the dentate line, when separating the muscle layer, the homeostasis of the submucosa layer is ensured. Then the rectum is pulled down to reveal the rectovaginal peritoneal fold. At this time, the peritoneum is opened from the anterior and lateral parts until the sigmoid colon is pulled down and the location of the intestinal tract is determined. The sigmoid mesentery is also separated and ligated. An incision is made in the anterior part of the sigmoid colon, here the first anastomotic sutures are created, then the same is done for the lateral and posterior parts of the sigmoid colon. Colon-anal anastomosis is reinforced with multiple sutures. Anastomosis can be performed with the help of a circular stapler depending on the conditions and decision of the surgeon. In order to repair the pelvic floor (levatorplasty) after the mesorectal dissection, the posterior wall of the vagina is dissected along with the fat tissue of the Douglas pouch so that the slings of the levator ani muscles appear. The sutures are pulled up from the peritoneum to the anterior wall of the sigmoid pouch of Douglas, and finally, the two arms of the levator ani muscle are connected in the midline and in front of the intestine with previous sutures, and the gap created in the pelvic diaphragm is repaired with anterior levatoroplasty. . This repair is usually done based on the surgeon's judgment during the operation for patients with narrow and weak levatorian muscles. Control group: A group in which post-anal repair surgery and levatoroplasty are not performed Improvement of patient's symptoms and incontinence after discomfort in two groups of Baya without post-anal repair and levatoroplasty. Timepoint: Patients are followed up in six times, one time before surgery and five times after surgery. Method of measurement: questionnaire. The recurrence rate of rectal prolapse after surgery in two groups with or without post-anal repair and levatoroplasty. Timepoint: Patients are followed up in six times, one time before surgery and five times after surgery. Method of measurement: questionnaire. Anastomotic dehiscence, stenosis, 3-month mortality after Eltamayer Bayabadon post-anal repair and levatoroplasty surgery. Timepoint: Patients are followed up in six times, one time before surgery and five times after surgery. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2022-02-02 Ethics committee in research of Imam (RA) Sari Educational and Therapeutic Hospital - Mazandaran Uni Amir Mazandarani Blvd Sari Mazandaran Iran (Islamic Republic of)