Modified Enhanced Recovery Program in Emergency Surgery (MERES)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of Modified Enhanced Recovery Program in Emergency Surgery

Conditions
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Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis With Peritonitis, Acute Appendicitis Without Peritonitis

Intervention / Treatment
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* Procedure: Laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified ERAS protocol group<br>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. Low pressure (8-9 mmHg) pneumoperitoneum. Routinely remove of appendix mesentery in presence of any signs of its inflammation. Additional local anesthesia with 0.25% ropivacaine. Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5). Postoperative care. Early mobilization (2 h after surgery) Early fluid intake (2 h after surgery) Early liquid food (6 h after surgery) | Procedure: Laparoscopic appendectomy<br>* 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.<br>|
| Placebo Comparator: Standard care group<br>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. Standard pressure (12-14 mmHg) pneumoperitoneum Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A). Appendix mesentery removing in the appearance of its necrotic changes. 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 | Procedure: Laparoscopic appendectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Postoperative pain | Level of postoperative pain syndrome measured with a visual analog scale in centimeters | 24 hours | 
| 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 | 
| Shoulder pain level | Level of shoulder pain syndrome measured with visual analog scale in centimeters | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery, fast-track, appendectomy, intraperitoneal anesthesia, low pressure pneumoperitoneum