Acute Appendicitis, Acute Appendicitis Without Peritonitis, Acute Appendicitis With Peritonitis, Acute Appendicitis With Rupture
Conditions
Keywords
enhanced recovery, fast-track, appendectomy, intraperitoneal anesthesia, low pressure pneumoperitoneum
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).
Interventions
PROCEDURELaparoscopic 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.
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Postoperative pain | 24 hours | Level of postoperative pain syndrome measured with a visual analog scale in centimeters |
| 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 |
Countries
Russia
Outcome results
None listed