Back to resultsOmitting Drains After Repair of Peptic Ulcer Perforations
Primary Purpose
Peptic Ulcer Perforations
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations
Using intraabdominal drains
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Perforations
Eligibility Criteria
Inclusion Criteria: - Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study. Exclusion Criteria: preoperative shock on admission. Delayed presentation more than 24 hours. known malignant gastric ulcers confirmed by histopathology. the presence of neuropsychiatric disease, pregnant and lactating women. predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS. Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Drain group
No drain group
Arm Description
In Group A the investigators will put intraabdominal drains
The investigators will not put any intraabdominal drains
Outcomes
Primary Outcome Measures
number of days of hospital stay
hospital stay length
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
incidence of Post operative repair leak
incidence of Post operative repair leak
Secondary Outcome Measures
number of days before frist bowel motion
number of days before frist bowel motion
severity of operative pain measured by Visual Analogue Scale (VAS
from 1 to 10 1 indicated minimum pain and 10 maximum pain
INCIDENCE OF postoperative nausea and vomiting (PONAV
INCIDENCE OF postoperative nausea and vomiting (PONAV
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06084741
Brief Title
Omitting Drains After Repair of Peptic Ulcer Perforations
Official Title
Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
November 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.
Detailed Description
Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Perforations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drain group
Arm Type
Active Comparator
Arm Description
In Group A the investigators will put intraabdominal drains
Arm Title
No drain group
Arm Type
Experimental
Arm Description
The investigators will not put any intraabdominal drains
Intervention Type
Other
Intervention Name(s)
Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations
Intervention Description
omitting the intraabdominal drains
Intervention Type
Other
Intervention Name(s)
Using intraabdominal drains
Intervention Description
The investigators will put intraabdominal drains
Primary Outcome Measure Information:
Title
number of days of hospital stay
Description
hospital stay length
Time Frame
Up to 30 days
Title
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
Description
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia
Time Frame
30 days
Title
incidence of Post operative repair leak
Description
incidence of Post operative repair leak
Time Frame
30 days
Secondary Outcome Measure Information:
Title
number of days before frist bowel motion
Description
number of days before frist bowel motion
Time Frame
7 days
Title
severity of operative pain measured by Visual Analogue Scale (VAS
Description
from 1 to 10 1 indicated minimum pain and 10 maximum pain
Time Frame
7 days
Title
INCIDENCE OF postoperative nausea and vomiting (PONAV
Description
INCIDENCE OF postoperative nausea and vomiting (PONAV
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.
Exclusion Criteria:
preoperative shock on admission.
Delayed presentation more than 24 hours.
known malignant gastric ulcers confirmed by histopathology.
the presence of neuropsychiatric disease, pregnant and lactating women.
predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS.
Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed ElShwadfy
Phone
+201025524630
Email
m.elshwadfy1988@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed salah
Phone
+201025524630
Email
Ahmed_m_salah@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed ElShwadfy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Taha, Professor
Phone
+20 120 173 0249
Email
kasralainyrec@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Omitting Drains After Repair of Peptic Ulcer Perforations
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