Clinical trial NCT04091815: Enhanced Recovery After Laparoscopic Colorectal Surgery Study
Official title: Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Colorectal Surgery
Keywords: Enhanced recovery
Multimodal analgesia
Quality of life
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.
Secondary outcomes:
measure: Total post-operative analgetics consumption
timeFrame: From time to PACU admission until 72 hours postoperatively
measure: Time to bowel movement
timeFrame: From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
measure: Time oral intake
timeFrame: From time of PACU admission until the date of first documented liquid oral intake.
measure: Time to ambulation
timeFrame: From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
measure: Time to urinary catheter removal
timeFrame: From time of PACU admission until the date of urinary catheter removed will be measured.
measure: Time to hospital discharge
timeFrame: From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
measure: Incidence of surgical complications
timeFrame: From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
measure: Readmission to the hospital
timeFrame: From the date of randomisation until 30 days postoperatively.
measure: Post-operative nausea and vomiting
timeFrame: Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
measure: Post-operative pruritus
timeFrame: From time to PACU admission until 72 hours postoperatively.
measure: Patient satisfaction
timeFrame: From time to PACU admission until discharge, every 6 hours for the first 24-hour, then every 12 hours until 72 hours.
measure: A measure of health status with EQ-5D-5L instrument
timeFrame: From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
affiliation: Vilnius University, Faculty of Medicine
name: Jurate Sipylaite, MD, PhD
role: STUDY_CHAIR
References: