Omitting Drains After Repair of Peptic Ulcer Perforations

Not Applicable

Recruiting

• Conditions: Peptic Ulcer Perforations
• Interventions: Other: Using intraabdominal drains; Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations

• Registration Number: NCT06084741
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-03-25
• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2023-11-25
• Study Completion: 2023-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drain group	Using intraabdominal drains	In Group A the investigators will put intraabdominal drains
No drain group	Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations	The investigators will not put any intraabdominal drains

Primary Outcome Measures

Name	Time	Method
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
incidence of Post operative repair leak	30 days	incidence of Post operative repair leak
number of days of hospital stay	Up to 30 days	hospital stay length

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt