NCT03754751

Brief Summary

The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
1.8 years 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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

January 15, 2021

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

November 21, 2018

Last Update Submit

January 14, 2021

Conditions

Acute CholecystitisGangrenous Cholecystitis

Keywords

enhanced recoveryintraperitoneal anesthesialow pressure pneumoperitoneumcholecystitisin-hospital staylaparoscopic cholecystectomy

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 program group

EXPERIMENTAL

Laparoscopic cholecystectomy with the implementation of modified ERAS program

Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program

Conventional care group

ACTIVE COMPARATOR

Laparoscopic cholecystectomy with standard perioperative treatment

Procedure: Laparoscopic cholecystectomy with standard perioperative treatment

Interventions

Laparoscopic cholecystectomy with the implementation of modified ERAS programPROCEDURE

Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1\) Patient informing and brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Low-pressure pneumoperitoneum (8-9 mmHg) 2. Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine 3. PONV prophylaxis in patients of risk 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) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h 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 program group
Laparoscopic cholecystectomy with standard perioperative treatmentPROCEDURE

Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1\) Patient oral informing. No brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Standard CO2 pressure (12-14 mmHg) 2. No additional anesthesia Postoperative care 1. Mobilization in 4-6 h after surgery 2. Fluid intake in 6 hours 3. Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h 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

Conventional care group

Eligibility Criteria

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

You may qualify if:

  • Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
  • ASA I and II.

You may not qualify if:

  • Severe acute cholecystitis (Grade III on TG13);
  • Patient's refusal to participate;
  • The language barrier;
  • Transfer to the intensive care unit after surgery;
  • ASA class ≥ III;
  • Conversion to open procedure;
  • Biliary hypertension detected during preoperative examination or intraoperatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taras Nechay

Moscow, 115569, Russia

Location

MeSH Terms

Conditions

Cholecystitis, AcuteCholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Alexander 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

January 31, 2017

Primary Completion

January 1, 2019

Study Completion

January 30, 2019

Last Updated

January 15, 2021

Record last verified: 2019-11

Locations

RU(1)