Back to resultsImpact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes
Primary Purpose
Prokinetic Use After Emergency Intestinal Anastomosis
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prokinetic Motility Agents as primpiram and gastreg
Sponsored by
About this trial
This is an interventional other trial for Prokinetic Use After Emergency Intestinal Anastomosis
Eligibility Criteria
Inclusion Criteria:
- all adult patients
Exclusion Criteria:
- pediatrics
- patients associated with comorbidities
- patients with electively resection and anastomosis
Sites / Locations
- Of medicine, Sohag university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Prokinetic use in accelerate healing of urgent intestinal anastomosis
Arm Description
Prikinetic agents administered immediately post operative and time of stay at hospital twice daily
Outcomes
Primary Outcome Measures
Leakage rate
Fecal fistula
Secondary Outcome Measures
Early bowel opening
Duration taken to patient to pass feces and flatus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290753
Brief Title
Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes
Official Title
Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Short and long_term Clinical Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prokinetic drugs used to accelerate healing of intestinal anastomosis of urgent cases which not prepared preoperative by increase intestinal motility and gastric emptying and decrease postoperative adhesions They are many types of prokinetics as cholinergic agonists, dopamine antagonist, serotonergic agonists and macrolides Agents of prokinetics administered immediately post operation and at the time of hospitalization
Detailed Description
By evaluation the effect of prokinetic use versus non use after emergency intestinal intestinal anastomosis on short and long term clinical outcome It will be prospective cohort study which conducted in sohag university hospital Study will include patients presented with urgent anastomosis Inclusion criteria: all adults underwent emergency intestinal anastomosis Exclusion criteria: pediatrics, patients with comorbidities and patients with electively resection and anastomosis.
Primary goals are to detect effect of prokinetics on incidence of leakage rate Secondary outcomes include early bowel opening, enteral feeding, post operative pain, wound infection and adhesion formation rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prokinetic Use After Emergency Intestinal Anastomosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prokinetic use in accelerate healing of urgent intestinal anastomosis
Arm Type
Other
Arm Description
Prikinetic agents administered immediately post operative and time of stay at hospital twice daily
Intervention Type
Drug
Intervention Name(s)
Prokinetic Motility Agents as primpiram and gastreg
Other Intervention Name(s)
Primpiram and gastreg and erythromycin
Intervention Description
Prospective cohort study to evaluate the effect of pro kinetic use in emergency intestinal anastomosis
Primary Outcome Measure Information:
Title
Leakage rate
Description
Fecal fistula
Time Frame
5 days postoperative
Secondary Outcome Measure Information:
Title
Early bowel opening
Description
Duration taken to patient to pass feces and flatus
Time Frame
3 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all adult patients
Exclusion Criteria:
pediatrics
patients associated with comorbidities
patients with electively resection and anastomosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa eldin Hassan, Professor
Organizational Affiliation
Professor of general surgery
Official's Role
Study Director
Facility Information:
Facility Name
Of medicine, Sohag university hospital
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Evaluate the use of prokinetic versus non use in emergency intestinal anastomosis
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
Evaluate effect of use of pro kinetic drug versus non use in emergency intestinal analstomosis
Citations:
PubMed Identifier
25667026
Citation
Acosta A, Camilleri M. Prokinetics in gastroparesis. Gastroenterol Clin North Am. 2015 Mar;44(1):97-111. doi: 10.1016/j.gtc.2014.11.008. Epub 2014 Dec 23.
Results Reference
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Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes
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