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IRCT20150124020767N2 IRCT 2020-02-18 Tabriz University of Medical Sciences evaluation of mesh rectopexy Evaluation of complications in two rectopexy techniques, mesh rectopexy and open posterior sacral rectopexy in children 2016-03-20 anticipated 25 Complete https://irct.ir/trial/44991 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization.Patients receive a number, respectively, in the study, and the odd numbers place in the control group and the even numbers in the control group, Blinding description: The patients, the researcher, and the analyzer are not aware of the groups. N/A Rectal prolapse. Intervention 1: Intervention group: Mesh rectopexy: Patients with refractory rectal prolapse to conservative management will be included in the study. In the case group, the mesh rectopexy procedure (using ribbon like sterile gauze) is performed. In this method, the perineal incision is made transversely as long as two centimeters between anus and coccyx. The longitudinal incision is then made in the pelvic diaphragm without damage to the muscles. A space is created in the retro-rectal area in the areolar tissue from anus to the sacrum promontory. This space opens and encompasses the posterior half of the rectum. Then the space is filled with about two meters of tape mesh and dressing is done. After a week the mesh will be removed and the wound will close spontaneously. The fibrosis created in this space causes the rectum to be fixed and not exit from anus. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published. Intervention 2: Control group: open posterior sacral rectopexy or standard method(Ashcraft technique): Patients with refractory rectal prolapse to conservative management will be included in the study. This procedure involves incising over sacrum bone and opening the pelvic space up to two centimeters from anus. The coccyx bone is removed. Rectum is separated from the sacrum. The meso-rectum is then destroyed. The rectum is fixed with a few sutures to the sacrum bone to prevent the rectum from descending and exiting from anus. The layers are closed in sequence and the operation is terminated. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: starting 6 months after publication To whom: people working in academic institutions Conditions: N/A Where to obtain: Email How to obtain: As soon as possible Comments:
public Masoud Jamshidi
Sheshglan st.
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2250 Masoudjamshidi@gmail.com Tabriz University of Medical Sciences scientific Masoud Jamshidi
Sheshglan
Tabriz Iran (Islamic Republic of) 5136735886 0098415262250 Masoudjamshidi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Children with refractory prolapse (including constipation and other predispositions) after one year medical treatment. 3 years 12 years Both History of underlying disease such as cystic fibrosis, allergy to cow's milk and parasitic diseases such as Trichiura Trichuris. History of previous anorectal surgery such as anoplasty and Hirschsprung's disease Other rectal diseases such as colitis and polyp and solitary rectal ulcer and colorectal tumors Severe malnutrition. K62.3 Rectal prolapse Treatment - Surgery Treatment - Surgery Intervention group: Mesh rectopexy: Patients with refractory rectal prolapse to conservative management will be included in the study. In the case group, the mesh rectopexy procedure (using ribbon like sterile gauze) is performed. In this method, the perineal incision is made transversely as long as two centimeters between anus and coccyx. The longitudinal incision is then made in the pelvic diaphragm without damage to the muscles. A space is created in the retro-rectal area in the areolar tissue from anus to the sacrum promontory. This space opens and encompasses the posterior half of the rectum. Then the space is filled with about two meters of tape mesh and dressing is done. After a week the mesh will be removed and the wound will close spontaneously. The fibrosis created in this space causes the rectum to be fixed and not exit from anus. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published. Control group: open posterior sacral rectopexy or standard method(Ashcraft technique): Patients with refractory rectal prolapse to conservative management will be included in the study. This procedure involves incising over sacrum bone and opening the pelvic space up to two centimeters from anus. The coccyx bone is removed. Rectum is separated from the sacrum. The meso-rectum is then destroyed. The rectum is fixed with a few sutures to the sacrum bone to prevent the rectum from descending and exiting from anus. The layers are closed in sequence and the operation is terminated. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published. Complication rate of prolapse repair. Timepoint: Complication rate after surgery. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2015-02-15 Tabriz University of Medical Sciences Daneshgah St. Tabriz East Azarbaijan Iran (Islamic Republic of)