- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07321743
Emergency Intestinal Anastmosis
December 22, 2025 updated by: Reham Zakaria Mohamed Ahmed, Zagazig University
A Comparative Study Between Stapled and Handsewn Intestinal Anastmosis in Emergency Laparotomy
The goal of this clinical trial is to compare the outcomes of emergency intestinal anastomosis after stapled and handsewn anastmosis. The main question it aims to answer are:
Is stapled intestinal anastmosis is better than handsewn anastmosis in emergency laparotomy?
Participants at surgical emergency unit:
- Had intestinal anastmosis either by stapler or handsewn.
- kept in hospital for follow up and detection of complications like wound infection and leakage.
- Either discharged or managed according to the complications
- Outcomes were compared between the two groups
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
Sharqia Province
-
Zagazig, Sharqia Province, Egypt, 44519
- Faculty of Medicine, Zagazig University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients admitted to emergency surgery and needed intestinal anastmosis
Exclusion Criteria:
- patients below 18 years old
- immune-compromised patients e.g. corticosteroids therapy, autoimmue disease
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: stapled group
|
cases with intestinal trauma, perforation or intestinal obstruction had emergency laparotomy and intestinal anastmosis was done
|
|
Active Comparator: handsewn group
|
cases with intestinal trauma, perforation or intestinal obstruction had emergency laparotomy and intestinal anastmosis was done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intestinal leakage
Time Frame: from one day to two weeks after surgery
|
intestinal leakage output calculated in ml by weighing dressing or calculating the drain output
|
from one day to two weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
operation time
Time Frame: from incision time to closure (0 to 5 hours)
|
operation time in minutes was calculated
|
from incision time to closure (0 to 5 hours)
|
|
bleeding
Time Frame: from one hour to two days after surgery
|
bleeding amount was calculated in ml
|
from one hour to two days after surgery
|
|
hospital stay
Time Frame: from one day to one month after surgery
|
hospital stay was recorded in days
|
from one day to one month after surgery
|
|
post-operative pain
Time Frame: from one to three days after after surgery
|
pain was evaluated by the visual analogue scale from 1 to 10. score 1 means least painful, score 10 means very painful
|
from one to three days after after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 20, 2024
Primary Completion (Actual)
December 20, 2025
Study Completion (Actual)
December 20, 2025
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 942\31-Dec-2024
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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