]>
IRCT20220430054701N1 IRCT 2022-05-11 Shahid Beheshti University of Medical Sciences Exercise therapy in midline incision laparotomy Supervised exercise therapy in patients treated with midline incision laparotomy: a clinical trial 2022-06-05 anticipated 40 Complete https://irct.ir/trial/63323 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation of patients will be based on simple randomization and with the help of accepted methods to generate a random sequence on the web. The site randomizer.org will be used by filling in the information of the number of patients, and two target groups, assigning an equal number in each group and selecting non-duplicate numbers in this plan. Based on the numbers with random sequences generated on the site, patients will be divided into two groups. The intervention group will be the exercise therapy intervention group and group B, which is the group of routine postoperative interventions will be the control group, Blinding description: The allocation will be concealed by using opaque, sealed envelopes that were consecutively numbered. Apart from the project coordinator, the patients, attending physician of supervised exercise therapy will be blinded to the intervention allocation. N/A Evaluation of complications of midline laparotomy surgery. Intervention 1: Intervention group: Patients aged 20-70 years treated with elective surgery or emergency with midline laparotomy incision for whom in the exercise therapy intervention group, exercise will be performed twice daily for 15 minutes under supervision during hospitalization. Intervention 2: Control group: Patients aged 20-70 years treated with elective surgery or midline laparotomy incision in the control group, patients will receive routine postoperative support protocol. No - There is not a plan to make this available Justification or reason for not sharing IPD is The study will continue in later phases and with follow-up in subsequent clinical trial studies with other exercise methods
public Azadeh Hakakzadeh
Shahid Chamran Highway, Yemen St. - Shahid Arabi St.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2990 3268 ahakakzade@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azadeh Hakakzadeh
Tehran - Shahid Chamran Highway, Yemen St. - Shahid Arabi St.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9780 ahakakzade@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients treated with midline incision laparotomy 20 years 70 years Both Evidence of recurrent or metastatic disease Use of immunosuppressive drugs Use of (ERAS )enhanced recovery after surgery for postoperative care Y40-Y84 Complications of medical and surgical care Rehabilitation Rehabilitation Intervention group: Patients aged 20-70 years treated with elective surgery or emergency with midline laparotomy incision for whom in the exercise therapy intervention group, exercise will be performed twice daily for 15 minutes under supervision during hospitalization Control group: Patients aged 20-70 years treated with elective surgery or midline laparotomy incision in the control group, patients will receive routine postoperative support protocol. Any surgical complication. Timepoint: Immediately after surgery, before discharge and 30 days after surgery. Method of measurement: Patient physical exam by the surgeon. Hospitalization duration. Timepoint: Immediately after surgery, before discharge. Method of measurement: Checking the patient files. Duration of first gas excretion after surgery. Timepoint: Immediately after surgery. Method of measurement: Inform the nurse ward and register on patient file. 30 seconds chair stand funtional test. Timepoint: Before discharge and 30 days after surgery. Method of measurement: Counting the number of complete repetitions of the standing-sitting cycle. Shahid Beheshti University of Medical Sciences Approved 2022-02-09 Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi Ave., Yemen Blvd., Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)