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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Two different types of anesthesia general vs combined (spinal and general)
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania
RECRUITINGPostoperative pain intensity
Number of patients with unsatisfactory pain relief evaluated with visual analogic scale (VAS \> 4, with 0-no pain, 10-worst possible pain)
Time frame: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.
Total post-operative analgetics consumption
Rescue analgesia will be given according to protocol (ketorolac, narcotics).
Time frame: From time to PACU admission until 72 hours postoperatively
Time to bowel movement
The times it takes for the first bowel movement after postoperative will be measured.
Time frame: From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
Time oral intake
The time it takes to start oral liquid intake postoperatively will be measured.
Time frame: From time of PACU admission until the date of first documented liquid oral intake.
Time to ambulation
The time it takes for the patient to ambulate successfully after the surgery will be measured.
Time frame: From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
Time to urinary catheter removal
The time it takes to urinary catheter removal.
Time frame: From time of PACU admission until the date of urinary catheter removed will be measured.
Time to hospital discharge
The time it takes the patient to be fully discharged from the hospital will be measured.
Time frame: From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Incidence of surgical complications
The incidence of surgical complications will be documented.
Time frame: From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Readmission to the hospital
If a patient will be readmitted to the hospital after being fully discharge, the event will be documented.
Time frame: From the date of randomisation until 30 days postoperatively.
Post-operative nausea and vomiting
Nausea will be evaluated by nausea/vomiting score 0 - 3 (0 - no nausea/vomiting, 3 - nausea/vomiting, \>3 times per day).
Time frame: Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
Post-operative pruritus
Pruritus will be evaluated with a numerical rating scale (0-no pruritus, 10-worst possible pruritus).
Time frame: From time to PACU admission until 72 hours postoperatively.
Patient satisfaction
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).
Time frame: 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
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'.
Time frame: From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.
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