ERAS in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair

Study Overview
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Brief Summary
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Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. The aim of this randomized controlled clinical trial was to investigate the feasibility of enhanced postoperative recovery pathways in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Detailed Description
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Perforated peptic ulcer (PPU) is a frequent emergency condition worldwide with associated mortality up to 30%. Open procedures have in the most part been replaced by laparoscopic techniques. The standard postoperative management of PPUD patients is predominantly based on traditional practices. Randomization will be made at the end of the surgical procedure. Patients will be included in groups 1 or2. Group 1 is the control group and will receive standard postoperative care, and group 2 is the ERAS group.The aim of this randomized controlled clinical trial was to investigate the feasibility of ERAS in patients who underwent laparoscopic repair for Perforated peptic ulcer.

Official Title
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Enhanced Recovery After Surgery in Patients With Perforated Peptic Ulcer Disease Who Underwent Laparoscopic Repair, a Randomised Controlled Clinical Trial

Conditions
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Hospital Stay, Hospital Cost

Intervention / Treatment
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* Combination Product: ERAS treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perforated ulcer less than 10 mm in size Patients received laprascopic repair Exclusion Criteria: - 1. refusal to join the study or sign the informed consent form 3. age younger than 18 years 3.the presence of any psychiatric or neurologic disease 4. class 3 and 4 surgical patients according to the classification of The American Society of Anesthesiologists 5. septic shock on admission 6. pregnancy 7. multiple perforated peptic ulcers 8. spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair 9.conversion to open technique 10. perforated ulcers that were not amenable to Graham patch repair because of size or technical considerations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard postoperative care group<br>Patients received standard postoperative care as ususal. | Combination Product: ERAS treatment<br>* The ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move.<br>|
| Experimental: ERAS group<br>Patients received postoperative ERAS treatment. | Combination Product: ERAS treatment<br>* The ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | The time patients stay in hospital. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforated peptic ulcer, Enhanced recovery after surgery, Laparoscopic repair, Complications