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

Capital Medical University

Status: Unknown

Conditions: Hospital Stay; Hospital Cost

Treatments: Combination Product: ERAS treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04039646

RASS-01

Details and patient eligibility

About

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 Open procedures have in the most part been replaced by laparoscopic techniques.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

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 Open procedures have in the most part been replaced by laparoscopic techniques.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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard postoperative care group

Active Comparator group

Description:

Patients received standard postoperative care as ususal.

Treatment:

Combination Product: ERAS treatment

ERAS group

Experimental group

Description:

Patients received postoperative ERAS treatment.

Treatment:

Combination Product: ERAS treatment