Prokinetic Use After Emergency Intestinal AnastomosisNCT05290753
Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Postoperative Clinical Outcomes
A study testing Prokinetic Motility Agents as primpiram and gastreg in people with Prokinetic Use After Emergency Intestinal Anastomosis, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prokinetic Use After Emergency Intestinal Anastomosis
- What is being tested?
- Prokinetic Motility Agents as primpiram and gastreg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all adult patients
Who cannot join
- pediatrics
- patients associated with comorbidities
- patients with electively resection and anastomosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Prokinetic Motility Agents as primpiram and gastreg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prokinetic Motility Agents as primpiram and gastregDrug
Also called Primpiram and gastreg and erythromycin
Prospective cohort study to evaluate the effect of pro kinetic use in emergency intestinal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Prokinetic use in accelerate healing of urgent intestinal anastomosis | Other | Prikinetic agents administered immediately post operative and time of stay at hospital twice daily Receives: Drug: Prokinetic Motility Agents as primpiram and gastreg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage rate
Fecal fistula
Measured: 5 days postoperative
Secondary outcomes (1)
Early bowel opening
Duration taken to patient to pass feces and flatus
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prokinetic Use After Emergency Intestinal AnastomosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Adel Noureldin, Sohag University
- Investigators
- Alaa eldin Hassan, Professor, Study director, Professor of general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290753
- Sponsor's protocol ID
- Soh-Med-22-02-09
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Evaluate the use of prokinetic versus non use in emergency intestinal anastomosis
Publications
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.
PubMed 25667026
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prokinetic Use After Emergency Intestinal Anastomosis on Short and long_term Clinical Outcome
- ClinicalTrials.gov ID
- NCT05290753
- Acronym / sponsor ID
- Soh-Med-22-02-09
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prokinetic use in accelerate healing of urgent intestinal anastomosis | Other | Drug: Prokinetic Motility Agents as primpiram and gastregPrikinetic agents administered immediately post operative and time of stay at hospital twice daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all adult patients
Key exclusion criteria (3 listed)
- pediatrics
- patients associated with comorbidities
- patients with electively resection and anastomosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prokinetic Motility Agents as primpiram and gastregAlso: Primpiram and gastreg and erythromycinProspective cohort study to evaluate the effect of pro kinetic use in emergency intestinal anastomosis | Drug | Prokinetic use in accelerate healing of urgent intestinal anastomosis |
Primary outcome
Leakage rate
Time frame: 5 days postoperative
Fecal fistula
1 secondary outcome
Early bowel opening
Time frame: 3 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Background: PubMed 25667026Acosta 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.
- Individual participant dataSharing planned: Yes. Evaluate the use of prokinetic versus non use in emergency intestinal anastomosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa eldin Hassan, Professor study director
Professor of general surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prokinetic Motility Agents as primpiram and gastreg in people with Prokinetic Use After Emergency Intestinal Anastomosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage rate (time frame: 5 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.