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

NCT04039646 | Unknown

• 1 other identifier: RASS-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 Open procedures have in the most part been replaced by laparoscopic techniques.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

Conditions

Hospital Stay; Hospital Cost

Keywords

Perforated peptic ulcer; Enhanced recovery after surgery; Laparoscopic repair; Complications

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  The time patients stay in hospital.

  30 days

Study Arms (2)

Standard postoperative care group

ACTIVE COMPARATOR

Patients received standard postoperative care as ususal.

Combination Product: ERAS treatment

ERAS group

EXPERIMENTAL

Patients received postoperative ERAS treatment.

Combination Product: ERAS treatment

Interventions

ERAS treatment COMBINATION_PRODUCT

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aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia.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.

ERAS group; Standard postoperative care group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Perforated ulcer less than 10 mm in size
• Patients received laprascopic repair

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Li Hua Tian

  Ethics center, Beijing Chaoyang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Gang Han, MD

CONTACT

+86013522867841; hjg211@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of General Surgery

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: July 31, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)