Enhanced Recovery After Laparoscopic Colorectal Surgery Study

Laparoscopic Colorectal Surgery Clinical Trial

Official title:

Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091815
• Other study ID #: 19BMT32
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2020
• Source: Vilnius University
• Contact: Egle Kontrimaviciute, MD, PhD
• Phone: 0037052365264
• Email: egle.kontrimaviciute[@]santa.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Colorectal Surgery

Intervention

Other:
• Type of anaesthesia
Two different types of anesthesia general vs combined (spinal and general)

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total post-operative analgetics consumption	Rescue analgesia will be given according to protocol (ketorolac, narcotics).	From time to PACU admission until 72 hours postoperatively
Secondary	Time to bowel movement	The times it takes for the first bowel movement after postoperative will be measured.	From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
Secondary	Time oral intake	The time it takes to start oral liquid intake postoperatively will be measured.	From time of PACU admission until the date of first documented liquid oral intake.
Secondary	Time to ambulation	The time it takes for the patient to ambulate successfully after the surgery will be measured.	From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
Secondary	Time to urinary catheter removal	The time it takes to urinary catheter removal.	From time of PACU admission until the date of urinary catheter removed will be measured.
Secondary	Time to hospital discharge	The time it takes the patient to be fully discharged from the hospital will be measured.	From the date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Secondary	Incidence of surgical complications	The incidence of surgical complications will be documented.	From date of randomisation until the date of hospital discharge, or 30 days postoperatively hospital postoperatively will be measured.
Secondary	Readmission to the hospital	If a patient will be readmitted to the hospital after being fully discharge, the event will be documented.	From the date of randomisation until 30 days postoperatively.
Secondary	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).	Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
Secondary	Post-operative pruritus	Pruritus will be evaluated with a numerical rating scale (0-no pruritus, 10-worst possible pruritus).	From time to PACU admission until 72 hours postoperatively.
Secondary	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).	From time to PACU admission until discharge, every 6 hours for the first 24-hour, then every 12 hours until 72 hours.
Secondary	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'.	From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.