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Completed

NCT Number: NCT03754777

Modified Enhanced Recovery Program in Emergency Surgery (MERES)

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.

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Key information

Conditions

Acute Appendicitis Acute Appendicitis With Peritonitis Acute Appendicitis With Rupture Acute Appendicitis Without Peritonitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taras Nechay

Moscow, 115569, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic appendectomy

Procedure

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.

Primary outcomes

  1. Postoperative length of stay (pLOS)

    Time frame: 30 days

    Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days

Secondary outcomes

  1. Complication rate

    Time frame: 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

  2. Readmission rate

    Time frame: 30 days

    Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage

  3. Postoperative pain

    Time frame: 24 hours

    Level of postoperative pain syndrome measured with a visual analog scale in centimeters

  4. Shoulder pain incidence

    Time frame: 24 hours

    Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage

  5. Shoulder pain level

    Time frame: 24 hours

    Level of shoulder pain syndrome measured with visual analog scale in centimeters

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

Evaluation of Modified Enhanced Recovery Program in Emergency Surgery

Acronym: MERES

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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