Complete ObstructionNCT07026201
Primary Anastomosis After Left Colectomy in Emergency Cases
A study testing colectomy with primary anastomosis in people with Complete Obstruction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Complete Obstruction
- What is being tested?
- colectomy with primary anastomosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 20 Mar 2025
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting to the emergency department with obstructed left colon
- Patients aged between 18 and 80 years old
- Decision of laparotomy is made
- Intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum)
- Patient agrees to participate in the study
Who cannot join
- Severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane)
- Marked decreased tissue vascularity due to distension
- Irresectable mass
- Rectal mass
- Patients refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.
Read the detailed description
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*
- Conditions
- Complete Obstruction
- Being tested
- colectomy with primary anastomosis
- Keywords
- left colon mass
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colectomy with primary anastomosisOther
Also called surgical management
left hemicolectomy or sigmoidectomy, formal resection was carried out following conventional steps of radical resection.with primary anastomosis
| Study group | Role | What they receive |
|---|---|---|
| patient with obstructing left colon mass | Other | formal exploration with resection and primary anastomosis Receives: Other: colectomy with primary anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Anastomotic Leakage Within 30 Days Post-Operatively
- Description: Percentage of patients who develop an anastomotic leak as diagnosed clinically or radiologically
- Unit of Measure: % of patients
- Assessment Method: Clinical signs and imaging (e.g., contrast-enhanced CT scan)
Measured: 30 days after surgery
Incidence of Surgical Site Infection
- Description: Percentage of patients who develop a surgical site infection within 30 days after the operation
- Unit of Measure: % of patients
- Assessment Method: Clinical evaluation and/or positive wound culture
Measured: 30 days after surgery
Secondary outcomes (4)
Incidence of Postoperative Ileus
- Description: Percentage of patients who experience postoperative ileus, defined as absence of bowel movement and need for nasogastric tube beyond 3 days post-surgery
- Unit of Measure: % of patients
- Assessment Method: Clinical observation and medical records
Measured: From date of surgery until first bowel movement, assessed up to 7 days post-surgery
Time to Restoration of Bowel Movement
- Description: Number of days until first recorded bowel movement after surgery
- Unit of Measure: Days
- Assessment Method: Patient report and nursing documentation
Measured: Assessed up to 7 days post-surgery
Length of Hospital Stay
- Description: Total number of days the patient remained in hospital after surgery
- Unit of Measure: Days
- Assessment Method: Hospital records
Measured: Assessed up to 14 days post-surgery
Readmission Rate Within 30 Days
- Description: Percentage of patients readmitted to any hospital within 30 days after initial discharge
- Unit of Measure: % of patients
- Assessment Method: Patient follow-up and hospital readmission records
Measured: Time Frame: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Mar 2024
- Primary completion20 Mar 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete ObstructionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim Magid, prof, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026201
- Sponsor's protocol ID
- IBR 00006373
- Status last verified
- Jun 2025
- First submitted
- 26 Apr 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Anastomosis After Left Colectomy in Emergency Cases
- ClinicalTrials.gov ID
- NCT07026201
- Acronym / sponsor ID
- IBR 00006373
- Conditions
- Complete Obstruction
- Keywords
- left colon mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 18 Jun 2025 (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.
The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.
Detailed description
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with obstructing left colon mass | Other | Other: colectomy with primary anastomosisformal exploration with resection and primary anastomosis |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting to the emergency department with obstructed left colon
- Patients aged between 18 and 80 years old
- Decision of laparotomy is made
- Intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum)
- Patient agrees to participate in the study
Key exclusion criteria (5 listed)
- Severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane)
- Marked decreased tissue vascularity due to distension
- Irresectable mass
- Rectal mass
- Patients refusing to participate in the study
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 |
|---|---|---|
| colectomy with primary anastomosisAlso: surgical managementleft hemicolectomy or sigmoidectomy, formal resection was carried out following conventional steps of radical resection.with primary anastomosis | Other | patient with obstructing left colon mass |
Primary outcome
Incidence of Anastomotic Leakage Within 30 Days Post-Operatively
Time frame: 30 days after surgery
* Description: Percentage of patients who develop an anastomotic leak as diagnosed clinically or radiologically * Unit of Measure: % of patients * Assessment Method: Clinical signs and imaging (e.g., contrast-enhanced CT scan)
Incidence of Surgical Site Infection
Time frame: 30 days after surgery
* Description: Percentage of patients who develop a surgical site infection within 30 days after the operation * Unit of Measure: % of patients * Assessment Method: Clinical evaluation and/or positive wound culture
4 secondary outcomes
Incidence of Postoperative Ileus
Time frame: From date of surgery until first bowel movement, assessed up to 7 days post-surgery
Time to Restoration of Bowel Movement
Time frame: Assessed up to 7 days post-surgery
Length of Hospital Stay
Time frame: Assessed up to 14 days post-surgery
Readmission Rate Within 30 Days
Time frame: Time Frame: 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Ibrahim Magid, prof principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colectomy with primary anastomosis in people with Complete Obstruction, run by Ain Shams 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Anastomotic Leakage Within 30 Days Post-Operatively (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.