Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes

April 30, 2022 updated by: Doha Adel Noureldin, Sohag University

Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Short and long_term Clinical Outcome

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Of medicine, Sohag university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all adult patients

Exclusion Criteria:

  • pediatrics
  • patients associated with comorbidities
  • patients with electively resection and anastomosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prokinetic use in accelerate healing of urgent intestinal anastomosis
Prikinetic agents administered immediately post operative and time of stay at hospital twice daily
Drug: Prokinetic Motility Agents as primpiram and gastreg
Prospective cohort study to evaluate the effect of pro kinetic use in emergency intestinal anastomosis
Other Names:
  • Primpiram and gastreg and erythromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leakage rate
Time Frame: 5 days postoperative
Fecal fistula
5 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early bowel opening
Time Frame: 3 days postoperative
Duration taken to patient to pass feces and flatus
3 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Alaa eldin Hassan, Professor, Professor of general surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 30, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-02-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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