Enhanced Recovery After Laparoscopic Colorectal Surgery Study

Not Applicable

• Conditions: Laparoscopic Colorectal Surgery
• Interventions: Other: Type of anaesthesia

• Registration Number: NCT04091815
• Lead Sponsor: Vilnius University

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.

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-09-14
• Study First Posted: 2019-09-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18
• Primary Completion: 2021-05-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II group - combined - spinal and general anaesthesia	Type of 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.
I group - general anaesthesia	Type of 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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity	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)

Secondary Outcome Measures

Name	Time	Method
Total post-operative analgetics consumption	From time to PACU admission until 72 hours postoperatively	Rescue analgesia will be given according to protocol (ketorolac, narcotics).
Time to bowel movement	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.
Time oral intake	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.
Time to ambulation	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.
Time to urinary catheter removal	From time of PACU admission until the date of urinary catheter removed will be measured.	The time it takes to urinary catheter removal.
Time to hospital discharge	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.
Post-operative nausea and vomiting	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).
Post-operative pruritus	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).
Patient satisfaction	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).
Incidence of surgical complications	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.
Readmission to the hospital	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.
A measure of health status with EQ-5D-5L instrument	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'.

Trial Locations

Locations (1)

Vilnius University Hospital Santaros Clinics; 🇱🇹 Vilnius, Lithuania