Surgery for Obstructed Gastric Carcinoma
Palliative Resection Versus Palliative Bypass in Obstructed Locally Advanced Gastric Carcinoma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharqia Province
-
Zagazig, Sharqia Province, Egypt, 44519
- Faculty of medicine, Zagazig university
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- emergency obstructed gastric cancer patients
Exclusion Criteria:
- non obstructed gastric cancer patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Group I: obstructed gastric cancer patients
patients presented with emergency gastric obstruction
|
distal, subtotal or total gastrectomy with gastro-jejunostomy or eosphago-jejunostomy will be done
|
|
Active Comparator: Group II: obstructed gastric cancer patients
patients presented with emergency gastric obstruction
|
palliative gastro-jejunostomy or eosphago-jejunostomy will be done
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper gastrointestinal symptoms
Time Frame: from one day to two weeks after surgery
|
upper gastrointestinal symptoms will be evaluated after surgery by Rhodes Index questionnaire.
It is a validated, self-report instrument used to measure the intensity, frequency, and distress of upper gastrointestinal symptoms.
The scale measures three main areas: nausea (frequency, duration, distress), vomiting (amount, frequency, distress), and retching (frequency, distress).
It utilizes a 5-point Likert scale (0-4) to quantify the severity of these symptoms.
0 is the least amount of distress and 4 is the most distress.
|
from one day to two weeks after surgery
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anastmotic leak
Time Frame: from day one to two weeks after surgery.
|
anastmotic site leakage will be assessed by abnormal discharge in the drain calculated in cc.
|
from day one to two weeks after surgery.
|
|
ICU admission
Time Frame: from day one to two weeks after surgery
|
the need of ICU admission will be evaluated by (yes or No)
|
from day one to two weeks after surgery
|
|
wound infection
Time Frame: from day one to one month after surgery
|
wound infection will be identified by presence of pus in the dressing and positive culture and sensitivity test
|
from day one to one month after surgery
|
|
mortality
Time Frame: from one day to one month after surgery
|
follow up of patient after surgery (died or not)
|
from one day to one month after surgery
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Reham Zakaria, M.D, Zagazig University, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2105\17-Feb-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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