Enhanced Recovery After Laparoscopic Colorectal Surgery Study

NCT ID: NCT04091815

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2022-01-01

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.

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.

Conditions

Laparoscopic Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Type of anaesthesia

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Type of anaesthesia

Intervention Type: OTHER

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

Interventions

Type of anaesthesia

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Egle Kontrimaviciute

MD, PhD, Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jurate Sipylaite, MD, PhD

Role: STUDY_CHAIR

Vilnius University, Faculty of Medicine

Locations

Vilnius University Hospital Santaros Clinics

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Central Contacts

Egle Kontrimaviciute, MD, PhD

Role: CONTACT

egle.kontrimaviciute@santa.lt

0037052365264

Agne Jankuviene, MD

Role: CONTACT

agnevasilkeviciute@gmail.com

0037052365264

Facility Contacts

Egle Kontrimaviciute, Assoc. Prof

Role: primary

egle.kontrimaviciute@santa.lt

+37052365264

Agne Jankuviene, MD

Role: backup

agne.vasilkeviciute@gmail.com

+37052365264

Other Identifiers

19BMT32

Identifier Type: -

Identifier Source: org_study_id