Enhanced Recovery After Laparoscopic Colorectal Surgery Study

September 17, 2020 updated by: Egle Kontrimaviciute, Vilnius University

Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes

The study will assess the impact on quality of care after implementation of the ERAS (Enhanced Recovery After Surgery) protocol for laparoscopic colorectal surgery in Vilnius University Hospital Santaros klinikos. The primary goal of this study is to compare efficacy of two different types of anaesthesia - general and combined (spinal and general), efficacy of multimodal analgesia in both groups, need for rescue analgetics, time to bowel movement, time to ambulation. We also aim to study overall patient satisfaction and measure health-related quality of life, from date of randomisation until the date of hospital discharge, 30 days, 3 months and 6 months post-discharge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Recovery After Surgery (ERAS) protocol is a multimodal perioperative care pathway designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery, now widely accepted in laparoscopic colorectal surgery.

In laparoscopic colorectal surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia and hypotension, prevention of volume overload, preference for minimally invasive surgery, multimodal analgesia with reduced opioid requirements, local anaesthetics for wound infiltration, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early postoperative feeding, to promote rapid recovery of gastrointestinal functions.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania
        • Recruiting
        • Vilnius University Hospital Santaros Clinics
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Smilte Kolevinskaite, MD
        • Sub-Investigator:
          • Laura Baltruskeviciute, Student
        • Sub-Investigator:
          • Domas Bubulis, Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older.
  • scheduled for laparoscopic colorectal surgery.
  • patient informed and having accepted the principle of enhanced recovery after surgery.
  • patient written consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

Preoperative:

  • patients who can not comply with the ERAS protocol because they do not understand the language or has a cognitive disorder.
  • patients with a documented allergy to nonsteroidal anti-inflammatory drugs and acetaminophen.
  • preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis.
  • patients with a history of hepatic impairment.
  • chronic pain condition that required daily opioid dependence.

Operative:

  • conversion to laparotomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: I group - general anaesthesia
General anesthesia, induction with fentanyl, propofol, roqurium. Maintenance - sevoflurane (BIS ranges 40 - 60), opioids (fentanyl and morphine), roqurium. Intraoperative fluid administration - 2000ml sterofundine, 500ml Gelaspan. 75mg intravenous diclofenac sodium on anesthesia induction, 1000mg intravenous acetaminophen at the start of wound closure. Surgical site infiltration, bupivacaine, 0.25%-10 ml, after the last suture.
Other: Type of anaesthesia
Two different types of anesthesia general vs combined (spinal and general)
EXPERIMENTAL: II group - combined - spinal and general anaesthesia

Spinal anesthesia: L3-4 interspace, 27G needle, bupivacaine hyperbaric, 16 mg, morphine sulfate 0.1% - 0.1ml.

General anesthesia, induction with fentanyl, propofol, roqurium. Maintenance - sevoflurane (BIS ranges 40 - 60), roqurium. Intraoperative fluid administration - 2000ml sterofundine, 500ml Gelaspan. 75mg intravenous diclofenac sodium on anesthesia induction, 1000mg intravenous acetaminophen at the start of wound closure. Surgical site infiltration, bupivacaine, 0.25%-10 ml, after the last suture.
Other: Type of anaesthesia
Two different types of anesthesia general vs combined (spinal and general)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.
Number of patients with unsatisfactory pain relief evaluated with visual analogic scale (VAS > 4, with 0-no pain, 10-worst possible pain)
From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total post-operative analgetics consumption
Time Frame: From time to PACU admission until 72 hours postoperatively
Rescue analgesia will be given according to protocol (ketorolac, narcotics).
From time to PACU admission until 72 hours postoperatively
Time to bowel movement
Time Frame: From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
The times it takes for the first bowel movement after postoperative will be measured.
From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
Time oral intake
Time Frame: From time of PACU admission until the date of first documented liquid oral intake.
The time it takes to start oral liquid intake postoperatively will be measured.
From time of PACU admission until the date of first documented liquid oral intake.
Time to ambulation
Time Frame: From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
The time it takes for the patient to ambulate successfully after the surgery will be measured.
From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
Time to urinary catheter removal
Time Frame: From time of PACU admission until the date of urinary catheter removed will be measured.
The time it takes to urinary catheter removal.
From time of PACU admission until the date of urinary catheter removed will be measured.
Time to hospital discharge
Time Frame: From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
The time it takes the patient to be fully discharged from the hospital will be measured.
From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Incidence of surgical complications
Time Frame: From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
The incidence of surgical complications will be documented.
From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Readmission to the hospital
Time Frame: From the date of randomisation until 30 days postoperatively.
If a patient will be readmitted to the hospital after being fully discharge, the event will be documented.
From the date of randomisation until 30 days postoperatively.
Post-operative nausea and vomiting
Time Frame: Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
Nausea will be evaluated by nausea/vomiting score 0 - 3 (0 - no nausea/vomiting, 3 - nausea/vomiting, >3 times per day).
Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
Post-operative pruritus
Time Frame: From time to PACU admission until 72 hours postoperatively.
Pruritus will be evaluated with a numerical rating scale (0-no pruritus, 10-worst possible pruritus).
From time to PACU admission until 72 hours postoperatively.
Patient satisfaction
Time Frame: From time to PACU admission until discharge, every 6 hours for the first 24-hour, then every 12 hours until 72 hours.
Overall patient satisfaction as well as satisfaction related to pain, nausea/vomiting and itching management will be measured.This will be measured with a numerical rating scale (0-being worst possible satisfaction and 10-best satisfaction).
From time to PACU admission until discharge, every 6 hours for the first 24-hour, then every 12 hours until 72 hours.
A measure of health status with EQ-5D-5L instrument
Time Frame: From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.
The descriptive system to assess a patient's health-related quality of life which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ instrument VAS scale records the respondent's self-rated health on a vertical, 0-100 visual analog scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 25, 2019

Primary Completion (ANTICIPATED)

May 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

September 14, 2019

First Posted (ACTUAL)

September 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19BMT32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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