- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716709
Bowel Obstruction Post Open Versus Laparoscopic Appendectomy
Comparative Study of Incidence of Bowel Obstruction Post Open Versus Laparoscopic Appendectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative bowel obstruction, often resulting from intra-abdominal adhesions, is a common and sometimes serious complication following abdominal surgeries. The pathogenesis of these adhesions can be influenced by several factors, including the extent of tissue handling, exposure of peritoneal surfaces, the degree of inflammation presents during surgery, and the surgical technique used .
Open surgery, by its nature, involves a larger incision and greater manipulation of intra-abdominal structures, which may predispose patients to more extensive adhesion formation and, subsequently, higher rates of bowel obstruction. On the other hand, laparoscopic surgery, with its minimal access approach, is associated with less tissue trauma and reduced adhesion formation in various abdominal procedures. However, it is not entirely devoid of risk, and rare but serious complications such as internal herniation and port site adhesions can also lead to bowel obstruction in laparoscopic cases .
The clinical presentation of postoperative bowel obstruction can vary widely, ranging from mild intermittent symptoms to complete mechanical obstruction requiring urgent reoperation. Understanding the relative risk and nature of bowel obstruction following laparoscopic versus open appendectomy is essential for both surgical decision-making and informed patient counseling. Moreover, identifying differences in the timing, severity, and management outcomes of this complication between the two surgical approaches may help refine perioperative strategies to minimize patient morbidity .
While several studies have attempted to compare postoperative outcomes between laparoscopic and open appendectomy, data specifically focusing on the incidence and characteristics of bowel obstruction are less abundant and sometimes conflicting . Some retrospective reviews suggest a lower incidence of bowel obstruction following laparoscopic appendectomy, while others report no significant difference. Variations in surgical technique, patient selection, underlying pathology, and follow-up duration may all contribute to these discrepancies .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- both genders
- confirmed diagnosis of acute appendicitis
- patients undergo laparoscopic or open appendectomy
Exclusion Criteria:
- appendectomy performed as apart of another operation
- prior history of abdominal surgery
- patients show generalized peritonitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
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Open appendectomy For gruop A
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Active Comparator: Gruop B
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Laparoscopic appendectomy for group B
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of bowel obstruction post laparoscopic versus open appendectomy
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• Operative time
Time Frame: : During operation (from incision to closure)
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: During operation (from incision to closure)
|
|
|
Analgesic requirement
Time Frame: From postoperative Day 0 through postoperative Day 7.
|
From postoperative Day 0 through postoperative Day 7.
|
|
|
Postoperative pain
Time Frame: Postoperative Day 1.
|
Postoperative pain assessed using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain).
|
Postoperative Day 1.
|
|
Post operative hospital stay
Time Frame: From the day of surgery until hospital discharge (average of 2-5 days).
|
From the day of surgery until hospital discharge (average of 2-5 days).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: osama abdlrahem oraby, professor, Sohag University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--25-9-9MSSohagUH-DT-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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