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IRCT20200907048652N1 IRCT 2020-10-05 Shiraz University of Medical Sciences A MODIFIED LAPAROSCOPIC APPENDICOSTOMY TECHNIQUE Laparoscopic Extraperitoneal Appendicostomy: A Modified Laparoscopic Appendicostomy Technique for Antegrade Continence Enema in children 2019-12-22 anticipated 30 Complete https://irct.ir/trial/50814 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The sample size was based on all available patients who fulfilled the inclusion criteria and were willing to participate in our study. The participants were prescribed 3 months of bowel management, Randomization description: Randomization will be based on permuted block randomization to control the effect of age and sex. Each block will have 6 capacities, ie, we will have 5 blocks of 6. After that, in each block, people randomly enter one of the laparoscopic surgery groups. Randomization within each block will be based on a table of random numbers, Blinding description: In this single-blind study, all patients and observers were not aware of the type of procedures, but their parents were totally informed. In fact, Only the surgeon aware of grouping all patients' guardians, and parents knew the exact possible procedures and completed the informed consent. On the other hand, observers measured patients 'satisfaction with the procedure, as well as information such as patients' need for reoperation, number of enema per day, and stoma leakage from the appendix tube, and they recorded all data by questionnaires and detailed daily observations. N/A Condition 1: functional constipation. Condition 2: Hirschsprung's disease. Condition 3: fecal incontinence. Condition 4: anorectal malformation. Intervention 1: Intervention group: Following anesthesia, a standard transumbilical approach is as follows. At first, a small orifice was created in the deepest portion of the umbilicus (V skin incision). A Veress needle was inserted into the abdomen, and the air entered the peritoneal cavity. After inserting a 5 mm trocar, the laparoscopic camera was inserted in the umbilicus to evaluate the intra-abdominal cavity and appendix. The second incision was made in the lower left quadrant (LLQ) to introduce the next trocar (5mm). After that, we repositioned the camera and entered the abdomen through the LLQ trocar. Occasionally, we required a third 3mm trocar inserted in the lower right quadrant (LRO) to mobilize and locate the appendix intraperitoneally to the umbilicus for fixation to the skin. To create a cavity and better dissection, 5-10 ml 0.9% Natrium chloride was injected subcutaneously between the abdominal wall and peritoneum under direct observation by laparoscopy, and a dissector was introduced into the newly created cavity through a 5 mm umbilical trocar which was displaced minimally into the new cavity between the peritoneum and abdominal wall. The abdominal wall was dissected and detached from peritoneum toward cecum. Finally, the dissector was entered into the abdominal cavity halfway between the umbilicus and cecum. Then a Grasper was introduced through an umbilical trocar and the tip of the appendix was taken and pulled through the umbilical port side and fixed to the skin. Subsequently, it worked as a one-way valve. Notably, N/S is injected before dissection of the peritoneum and abdominal wall for a better view of the dissector. Intervention 2: Control group: the control group underwent the conventional type of Laparoscopic Continence Enema, which is somehow similar to our technique except that the appendix duct is pulled out from the intraperitoneal cavity without crossing between the peritoneum and fascia. Yes - There is a plan to make this available What will be shared: study design and protocol, statistical process, and the procedure method in detail are planned to share. Patients’ information was de-identified prior to data analysis and confidentiality of patient information was guaranteed and protected by recording only the necessary information regarding this study. When: The data will be available since publishing the manuscript which would be probably right after receiving the Clinical trial code ( September 2020) To whom: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Conditions: Access to the data means analyzing them at the discretion of the applicant and communicating with the responsible author. Where to obtain: Data will be shared just by the corresponding author of the manuscript. How to obtain: Access to the data will only be possible via email to the responsible author and their response Comments:
public Hamidreza
department of pediatric surgery, Namazee hospital, Namazi square
Shiraz Iran (Islamic Republic of) 7186611555 +98 71 3631 1594 forotanh@yahoo.com Shiraz University of Medical Sciences scientific Hamidreza Foroutan
department of pediatric surgery, Namazee hospital, Namazi square
Shiraz Iran (Islamic Republic of) 7186611555 +98 71 3631 1594 forotanh@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The study population group consisted of 30 children aged 5-15 years who had functional constipation due to Hirschsprung's disease, and stool incontinence caused by anorectal malformations no limit 16 years Both All patients with a history of a previous laparotomy, cecal and appendix manipulation, short appendix length, and previous appendectomy were excluded. K59.0 Q43.1 R15 Constipation Hirschsprung's disease Fecal incontinence Treatment - Surgery Treatment - Surgery Intervention group: Following anesthesia, a standard transumbilical approach is as follows. At first, a small orifice was created in the deepest portion of the umbilicus (V skin incision). A Veress needle was inserted into the abdomen, and the air entered the peritoneal cavity. After inserting a 5 mm trocar, the laparoscopic camera was inserted in the umbilicus to evaluate the intra-abdominal cavity and appendix. The second incision was made in the lower left quadrant (LLQ) to introduce the next trocar (5mm). After that, we repositioned the camera and entered the abdomen through the LLQ trocar. Occasionally, we required a third 3mm trocar inserted in the lower right quadrant (LRO) to mobilize and locate the appendix intraperitoneally to the umbilicus for fixation to the skin. To create a cavity and better dissection, 5-10 ml 0.9% Natrium chloride was injected subcutaneously between the abdominal wall and peritoneum under direct observation by laparoscopy, and a dissector was introduced into the newly created cavity through a 5 mm umbilical trocar which was displaced minimally into the new cavity between the peritoneum and abdominal wall. The abdominal wall was dissected and detached from peritoneum toward cecum. Finally, the dissector was entered into the abdominal cavity halfway between the umbilicus and cecum. Then a Grasper was introduced through an umbilical trocar and the tip of the appendix was taken and pulled through the umbilical port side and fixed to the skin. Subsequently, it worked as a one-way valve. Notably, N/S is injected before dissection of the peritoneum and abdominal wall for a better view of the dissector. Control group: the control group underwent the conventional type of Laparoscopic Continence Enema, which is somehow similar to our technique except that the appendix duct is pulled out from the intraperitoneal cavity without crossing between the peritoneum and fascia. Complete remission of constipation. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: questionnaire. Ease of catheterization. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: questionnaire. Stomal leakage. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: questionnaire. Stomal stenosis. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: observation and tube test. Need for re-operation. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: observation. The number of enemas per day. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: questionnaire. Days of hospital admission. Timepoint: just after the procedure. Method of measurement: observation. Satisfaction rate. Timepoint: just after the surgery and 1, 2, and 6 months following the procedure. Method of measurement: questionnaire. Shiraz University of Medical Sciences Approved 2019-12-21 Medical Ethics Committee of Shiraz University of Medical Sciences unit 2-nastaran bldg-8th alley- azim street- west qodusi blvd Shiraz Fars Iran (Islamic Republic of)