Omitting Drains After Repair of Peptic Ulcer Perforations

Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study

. 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.

Study Overview

• Status: Recruiting
• Conditions: Peptic Ulcer Perforations
• Intervention / Treatment: Other: Using intraabdominal drains; Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed ElShwadfy; Phone Number: +201025524630; Email: m.elshwadfy1988@gmail.com
• Study Contact Backup: Name: ahmed salah; Phone Number: +201025524630; Email: Ahmed_m_salah@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Cairo University
    • Contact: Ahmed Taha, Professor; Phone Number: +20 120 173 0249; Email: kasralainyrec@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drain group; In Group A the investigators will put intraabdominal drains	Other: Using intraabdominal drains; The investigators will put intraabdominal drains
Experimental: No drain group; The investigators will not put any intraabdominal drains	Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations; omitting the intraabdominal drains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days of hospital stay	hospital stay length	Up to 30 days
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	30 days
incidence of Post operative repair leak	incidence of Post operative repair leak	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days before frist bowel motion	number of days before frist bowel motion	7 days
severity of operative pain measured by Visual Analogue Scale (VAS	from 1 to 10 1 indicated minimum pain and 10 maximum pain	7 days
INCIDENCE OF postoperative nausea and vomiting (PONAV	INCIDENCE OF postoperative nausea and vomiting (PONAV	7 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohammed ElShwadfy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Estimated): November 25, 2023
• Study Completion (Estimated): December 25, 2023

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: N-79-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No