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

Not Applicable

• Conditions: Hospital Cost; Hospital Stay
• Interventions: Combination Product: ERAS treatment

• Registration Number: NCT04039646
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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 Open procedures have in the most part been replaced by laparoscopic techniques.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

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 Open procedures have in the most part been replaced by laparoscopic techniques.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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Perforated ulcer less than 10 mm in size
2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard postoperative care group	ERAS treatment	Patients received standard postoperative care as ususal.
ERAS group	ERAS treatment	Patients received postoperative ERAS treatment.

Primary Outcome Measures

Name	Time	Method
Hospital stay	30 days	The time patients stay in hospital.

Trial Locations

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China