Modified Enhanced Recovery Program in Emergency Surgery (MERES)

Pirogov Russian National Research Medical University

Status: Completed

Conditions: Acute Appendicitis With Peritonitis; Acute Appendicitis Without Peritonitis; Acute Appendicitis With Rupture; Acute Appendicitis

Treatments: Procedure: Laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03754777

MERES

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups, including a placebo group

Modified ERAS protocol group

Experimental group

Description:

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)

Treatment:

Procedure: Laparoscopic appendectomy

Standard care group

Placebo Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic appendectomy