Clinical trial NCT03754777: Modified Enhanced Recovery Program in Emergency Surgery (MERES)
Official title: Evaluation of Modified Enhanced Recovery Program in Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Acute Appendicitis With Rupture
Acute Appendicitis With Peritonitis
Acute Appendicitis Without Peritonitis
Keywords: enhanced recovery
fast-track
appendectomy
intraperitoneal anesthesia
low pressure pneumoperitoneum
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay (pLOS)
timeFrame: 30 days
Secondary outcomes:
measure: Complication rate
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 24 hours
measure: Shoulder pain incidence
timeFrame: 24 hours
measure: Shoulder pain level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Taras Nechay
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Alexander V Sazhin, Prof.
role: STUDY_CHAIR
References:
citation: Sazhin AV, Nechay TV, Titkova SM, Petukhov VA, Tyagunov AE, Stradymov EA, Ermakov IV, Mishakina NY. [Appendectomy technique: paradigm shift or a well-forgotten old one? The role of mesoappendectomy in prevention of infectious intra-abdominal complications (announcement of RCT)]. Khirurgiia (Mosk). 2020;(10):49-59. doi: 10.17116/hirurgia202010149. Russian.
citation: Nechay T, Sazhin A, Titkova S, Tyagunov A, Anurov M, Melnikov-Makarchuk K, Tyagunov A. Evaluation of enhanced recovery after surgery program components implemented in laparoscopic appendectomy: prospective randomized clinical study. Sci Rep. 2020 Jul 1;10(1):10749. doi: 10.1038/s41598-020-67591-5.