Acute AppendicitisMERESNCT03754777

Modified Enhanced Recovery Program in Emergency Surgery (MERES)

A study testing Laparoscopic appendectomy in people with Acute Appendicitis and Acute Appendicitis With Rupture, run by Pirogov Russian National Research Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis With Peritonitis
What is being tested?: Laparoscopic appendectomy
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 1 siteRussia
Study dates: 1 Jul 2017to 1 Feb 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Taras Nechay
Moscow, 115569

Other trials in Russia

About this study

Official title: Evaluation of Modified Enhanced Recovery Program in Emergency Surgery

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.

Read the 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).

Conditions: Acute Appendicitis, Acute Appendicitis With Rupture, Acute Appendicitis With Peritonitis, Acute Appendicitis Without Peritonitis
Being tested: Laparoscopic appendectomy
Keywords: enhanced recovery, fast-track, appendectomy, intraperitoneal anesthesia, low pressure pneumoperitoneum
Medical subject headings: Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic appendectomyProcedure or surgery
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.

Study groups in NCT03754777
Study group	Role	What they receive
Modified ERAS protocol group	Experimental	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. 1. Low pressure (8-9 mmHg) pneumoperitoneum. 2. Routinely remove of appendix mesentery in presence of any signs of its inflammation. 3. Additional local anesthesia with 0.25% ropivacaine. 4. Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5). Postoperative care. 1. Early mobilization (2 h after surgery) 2. Early fluid intake (2 h after surgery) 3. Early liquid food (6 h after surgery) Receives: Procedure: Laparoscopic appendectomy
Standard care group	Placebo comparator	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. 1. Standard pressure (12-14 mmHg) pneumoperitoneum 2. Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A). 3. Appendix mesentery removing in the appearance of its necrotic changes. 4. 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 Receives: Procedure: Laparoscopic appendectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30 days

Secondary outcomes (5)

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
Measured: 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
Measured: 30 days
Postoperative pain
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Measured: 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
Measured: 24 hours
Shoulder pain level
Level of shoulder pain syndrome measured with visual analog scale in centimeters
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20171 Feb 2018

First posted27 Nov 2018
Study start1 Jul 2017
Primary completion1 Dec 2017
Study completion1 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute AppendicitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03754777
Sponsor's protocol ID: MERES
Acronym: MERES
Status last verified: Sep 2018
First submitted: 21 Nov 2018
Last updated: 27 Nov 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33047586
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.
PubMed 32612104

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess

All Acute Appendicitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Modified Enhanced Recovery Program in Emergency Surgery
ClinicalTrials.gov ID: NCT03754777
Acronym / sponsor ID: MERES / MERES
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Pirogov Russian National Research Medical UniversityUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 1 Dec 2017 (actual)
Study completion: 1 Feb 2018 (actual)
First posted: 27 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Modified ERAS protocol group	Experimental	Procedure: Laparoscopic appendectomyLaparoscopic 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. 1. Low pressure (8-9 mmHg) pneumoperitoneum. 2. Routinely remove of appendix mesentery in presence of any signs of its inflammation. 3. Additional local anesthesia with 0.25% ropivacaine. 4. Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5). Postoperative care. 1. Early mobilization (2 h after surgery) 2. Early fluid intake (2 h after surgery) 3. Early liquid food (6 h after surgery)
Standard care group	Placebo comparator	Procedure: Laparoscopic appendectomyStandard 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. 1. Standard pressure (12-14 mmHg) pneumoperitoneum 2. Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A). 3. Appendix mesentery removing in the appearance of its necrotic changes. 4. 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laparoscopic appendectomyPreoperative 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.	Procedure or surgery	Modified ERAS protocol group, Standard care group

Primary outcome

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

5 secondary outcomes

Complication rate
Time frame: 30 days
Readmission rate
Time frame: 30 days
Postoperative pain
Time frame: 24 hours
Shoulder pain incidence
Time frame: 24 hours
Shoulder pain level
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Derived from this study: PubMed 33047586Sazhin 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.
Derived from this study: PubMed 32612104Nechay 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.
Individual participant dataSharing planned: Undecided

Related trials for Acute Appendicitis

RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander V Sazhin, Prof. study chair

Pirogov Russian National Research Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic appendectomy in people with Acute Appendicitis and Acute Appendicitis With Rupture, run by Pirogov Russian National Research Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative length of stay (pLOS) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03754777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.