NCT03754777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

November 27, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

November 21, 2018

Last Update Submit

November 26, 2018

Conditions

Acute AppendicitisAcute Appendicitis With RuptureAcute Appendicitis With PeritonitisAcute Appendicitis Without Peritonitis

Keywords

enhanced recoveryfast-trackappendectomyintraperitoneal anesthesialow pressure pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days

Secondary Outcomes (5)

  • Complication rate

    30 days

  • Readmission rate

    30 days

  • Postoperative pain

    24 hours

  • Shoulder pain incidence

    24 hours

  • Shoulder pain level

    24 hours

Study Arms (2)

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)

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

Procedure: Laparoscopic appendectomy

Interventions

Laparoscopic appendectomyPROCEDURE

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.

Modified ERAS protocol groupStandard care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taras Nechay

Moscow, 115569, Russia

Location

Related Publications (2)

  • 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.

    PMID: 33047586DERIVED

  • 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.

    PMID: 32612104DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Alexander V Sazhin, Prof.

    Pirogov Russian National Research Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 27, 2018

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-09

Locations

RU(1)