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Modified Enhanced Recovery Program in Emergency Surgery (MERES) (MERES)

Primary Purpose

Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis With Peritonitis

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Laparoscopic appendectomy
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Appendicitis focused on measuring enhanced recovery, fast-track, appendectomy, intraperitoneal anesthesia, low pressure pneumoperitoneum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taras Nechay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified ERAS protocol group

Standard care group

Arm 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. 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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Readmission rate
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Postoperative pain
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Shoulder pain incidence
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Shoulder pain level
Level of shoulder pain syndrome measured with visual analog scale in centimeters

Full Information

First Posted
November 21, 2018
Last Updated
November 26, 2018
Sponsor
Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03754777
Brief Title
Modified Enhanced Recovery Program in Emergency Surgery (MERES)
Acronym
MERES
Official Title
Evaluation of Modified Enhanced Recovery Program in Emergency Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified ERAS protocol group
Arm Type
Experimental
Arm 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. 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)
Arm Title
Standard care group
Arm Type
Placebo Comparator
Arm 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. 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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
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 Outcome Measure Information:
Title
Postoperative length of stay (pLOS)
Description
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Complication rate
Description
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
Time Frame
30 days
Title
Readmission rate
Description
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Time Frame
30 days
Title
Postoperative pain
Description
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Time Frame
24 hours
Title
Shoulder pain incidence
Description
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Time Frame
24 hours
Title
Shoulder pain level
Description
Level of shoulder pain syndrome measured with visual analog scale in centimeters
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V Sazhin, Prof.
Organizational Affiliation
Pirogov Russian National Research Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Taras Nechay
City
Moscow
ZIP/Postal Code
115569
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33047586
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.
Results Reference
derived
PubMed Identifier
32612104
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. Erratum In: Sci Rep. 2021 Sep 14;11(1):18646.
Results Reference
derived

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Modified Enhanced Recovery Program in Emergency Surgery (MERES)

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