Enhanced Recovery After Laparoscopic Colorectal Surgery Study

NCT04091815 | Unknown

• 1 other identifier: 19BMT32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Colorectal Surgery

Keywords

Enhanced recovery; Multimodal analgesia; Quality of life

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  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 Outcomes (12)

• Total post-operative analgetics consumption

  From time to PACU admission until 72 hours postoperatively

• Time to bowel movement

  From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.

• Time oral intake

  From time of PACU admission until the date of first documented liquid oral intake.

• Time to ambulation

  From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.

• Time to urinary catheter removal

  From time of PACU admission until the date of urinary catheter removed will be measured.

Study Arms (2)

I group - general anaesthesia

ACTIVE COMPARATOR

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

II group - combined - spinal and general anaesthesia

EXPERIMENTAL

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

Interventions

Type of anaesthesia OTHER

Two different types of anesthesia general vs combined (spinal and general)

I group - general anaesthesia; II group - combined - spinal and general anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

RECRUITING

Study Officials

• Jurate Sipylaite, MD, PhD

  Vilnius University, Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Egle Kontrimaviciute, MD, PhD

CONTACT

0037052365264; egle.kontrimaviciute@santa.lt

Agne Jankuviene, MD

CONTACT

0037052365264; agnevasilkeviciute@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assoc Prof

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 17, 2019
• Study Start: June 25, 2019
• Primary Completion: May 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)