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

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 Open procedures have in the most part been replaced by laparoscopic techniques.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 Open procedures have in the most part been replaced by laparoscopic techniques.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

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

Trial contacts and locations

1

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Central trial contact

Jia Gang Han, MD

Data sourced from clinicaltrials.gov

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