Laparoscopic Colorectal SurgeryNCT04091815
Enhanced Recovery After Laparoscopic Colorectal Surgery Study
A study testing Type of anaesthesia in people with Laparoscopic Colorectal Surgery, run by Vilnius University at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colorectal Surgery
- What is being tested?
- Type of anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 25 Jun 2019to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Clinics
Vilnius
Egle Kontrimaviciute, Assoc. Prof, +37052365264, egle.kontrimaviciute@santa.lt
Agne Jankuviene, MD, +37052365264, agne.vasilkeviciute@gmail.com
About this study
Official title: Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes
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.
Read the 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
- Being tested
- Type of anaesthesia
- Keywords
- Enhanced recovery, Multimodal analgesia, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of anaesthesiaOther
Two different types of anesthesia general vs combined (spinal and general)
| Study group | Role | What they receive |
|---|---|---|
| I group - general anaesthesia | Active comparator | 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. Receives: Other: Type of anaesthesia |
| II group - combined - spinal and general anaesthesia | Experimental | 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. Receives: Other: Type of anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.
Secondary outcomes (12)
Total post-operative analgetics consumption
Rescue analgesia will be given according to protocol (ketorolac, narcotics).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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'.
Measured: From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start25 Jun 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egle Kontrimaviciute, Vilnius University
- Investigators
- Jurate Sipylaite, MD, PhD, Study chair, Vilnius University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091815
- Sponsor's protocol ID
- 19BMT32
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced Recovery (ERAS) Protocol After Laparoscopic Colorectal Surgery Implementation on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04091815
- Acronym / sponsor ID
- 19BMT32
- Conditions
- Laparoscopic Colorectal Surgery
- Keywords
- Enhanced recovery, Multimodal analgesia, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I group - general anaesthesia | Active comparator | Other: Type of anaesthesiaGeneral 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. |
| II group - combined - spinal and general anaesthesia | Experimental | Other: Type of anaesthesiaSpinal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of anaesthesiaTwo different types of anesthesia general vs combined (spinal and general) | Other | I group - general anaesthesia, II group - combined - spinal and general anaesthesia |
Primary outcome
Postoperative pain intensity
Time frame: 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)
12 secondary outcomes
Total post-operative analgetics consumption
Time frame: From time to PACU admission until 72 hours postoperatively
Time to bowel movement
Time frame: From time of PACU admission until the date of first documented bowel mowement, assessed 24 hours postoperatively.
Time oral intake
Time frame: From time of PACU admission until the date of first documented liquid oral intake.
Time to ambulation
Time frame: From time of PACU admission until the first documented ambulation, assessed 72 hours postoperatively.
Time 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
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
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
Time frame: From the date of randomisation until 30 days postoperatively.
Post-operative nausea and vomiting
Time frame: Nausea/vomiting will be evaluated from time to PACU admission until 72 hours postoperatively.
Post-operative pruritus
Time frame: From time to PACU admission until 72 hours postoperatively.
Patient 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
Time frame: From the date of randomization until the date of hospital discharge. Then after 30 days, 3 months and 6 months post-discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurate Sipylaite, MD, PhD study chair
Vilnius University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of anaesthesia in people with Laparoscopic Colorectal Surgery, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Egle Kontrimaviciute, MD, PhD (0037052365264, egle.kontrimaviciute@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: From time to PACU admission until discharge. Every 6 hour for first 24-hour, then every 12 hour until 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.