Omitting Drains After Repair of Peptic Ulcer Perforations

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06084741
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 13.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer Perforations	Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations; Other: Using intraabdominal drains	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study
• Actual Study Start Date: Mar 25, 2023
• Anticipated Primary Completion Date: Nov 25, 2023
• Anticipated Study Completion Date: Dec 25, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of days of hospital stay [Up to 30 days]

   hospital stay length

2. number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia [30 days]

   number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

3. incidence of Post operative repair leak [30 days]

   incidence of Post operative repair leak

Secondary Outcome Measures

1. number of days before frist bowel motion [7 days]

   number of days before frist bowel motion

2. severity of operative pain measured by Visual Analogue Scale (VAS [7 days]

   from 1 to 10 1 indicated minimum pain and 10 maximum pain

3. INCIDENCE OF postoperative nausea and vomiting (PONAV [7 days]

   INCIDENCE OF postoperative nausea and vomiting (PONAV

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	11511

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Mohammed ElShwadfy, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Elshwadfy Nageeb, Lecturer of general surgery, Cairo University
• ClinicalTrials.gov Identifier: NCT06084741
• Other Study ID Numbers: N-79-2023
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peptic Ulcer; Peptic Ulcer Perforation; Ulcer

Study Results

No Results Posted as of Oct 16, 2023