Modified Enhanced Recovery Program in Emergency Surgery (MERES)

Acute Appendicitis Clinical Trial

— MERES  

Official title:

Evaluation of Modified Enhanced Recovery Program in Emergency Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754777
• Other study ID #: MERES
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: September 2018
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost 10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS) program has proven its effectiveness in elective surgery and can theoretically improve outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to investigate the safety and efficacy of a modified ERAS protocol in LA.

Description:

A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing, limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics; low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of stay (pLOS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with any stage of acute appendicitis except 3B according to Gomes classification;

• Class I-II surgical patients according to the classification of The American Society of Anesthesiologists (ASA).

Exclusion Criteria:

• Patient refusal to participate in the study or to sign the informed consent form;

• Language barrier;

• Transfer to the intensive care unit (ICU) after surgery;

• ASA class = III;

• Conversion to open procedure;

• Appendicular mass found during laparoscopy;

• Gomes 3B appendicitis requiring immersion of the appendicular stump;

• Pregnancy.

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Appendicitis With Peritonitis
• Acute Appendicitis With Rupture
• Acute Appendicitis Without Peritonitis
• Acute Disease
• Appendicitis
• Emergencies
• Peritonitis
• Rupture

Intervention

Procedure:
• Laparoscopic appendectomy
Preoperative care in both arms. Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. Surgery. General anesthesia with strict control of fluid therapy and hemodynamic changes during surgery. Appendectomy with the use of monopolar coagulation by experienced surgeons following appendix stump ligation by two Roeder knots. Postoperative care. Antibiotics for 3-5 days for patients with complicated appendicitis (Gomez = 3A). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 2, 6, 12 and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level = 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery.

Locations

Country	Name	City	State
Russian Federation	Taras Nechay	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative length of stay (pLOS)	Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days	30 days
Secondary	Complication rate	Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage	30 days
Secondary	Readmission rate	Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage	30 days
Secondary	Postoperative pain	Level of postoperative pain syndrome measured with a visual analog scale in centimeters	24 hours
Secondary	Shoulder pain incidence	Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage	24 hours
Secondary	Shoulder pain level	Level of shoulder pain syndrome measured with visual analog scale in centimeters	24 hours