Modified Enhanced Recovery Program in Emergency Surgery (MERES)

Not Applicable

Completed

• Conditions: Acute Appendicitis; Acute Appendicitis With Peritonitis; Acute Appendicitis With Rupture; Acute Appendicitis Without Peritonitis
• Interventions: Procedure: Laparoscopic appendectomy

• Registration Number: NCT03754777
• Lead Sponsor: Pirogov Russian National Research Medical University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-02-01
• Status Verified: 2018-09
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care group	Laparoscopic appendectomy	Standard care laparoscopic appendectomy. Preadmission. Not available due to emergency setting. Preoperative care. 1) Patient oral informing about the type of pathology, surgery procedure and possible complications. No brochure. Surgery. 1. Standard pressure (12-14 mmHg) pneumoperitoneum 2. Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A). 3. Appendix mesentery removing in the appearance of its necrotic changes. 4. No intraabdominal anesthesia. Postoperative care. 1) Mobilization in 4-6 h after surgery 2) Fluid intake in 6 hours 3) Liquid food intake in 12 hours
Modified ERAS protocol group	Laparoscopic appendectomy	Laparoscopic appendectomy with modified ERAS protocol group Preadmission. Not available due to the emergency setting. Preoperative care. 1) Patient brochure with a detailed description of the type of pathology, surgery procedure, rehabilitation process, possible complications, and other. Surgery. 1. Low pressure (8-9 mmHg) pneumoperitoneum. 2. Routinely remove of appendix mesentery in presence of any signs of its inflammation. 3. Additional local anesthesia with 0.25% ropivacaine. 4. Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5). Postoperative care. 1. Early mobilization (2 h after surgery) 2. Early fluid intake (2 h after surgery) 3. Early liquid food (6 h after surgery)

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay (pLOS)	30 days	Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours	Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Readmission rate	30 days	Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Complication rate	30 days	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
Shoulder pain incidence	24 hours	Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Shoulder pain level	24 hours	Level of shoulder pain syndrome measured with visual analog scale in centimeters

Trial Locations

Locations (1)

Taras Nechay; 🇷🇺 Moscow, Russian Federation