Postoperative PainNCT04997174
Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery
An observational study of Postoperative Pain, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Celecoxib
- How many people
- 162 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2021to Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group of interest: Laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery [laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others] under ERAS protocol. Control 1: Laparoscopic colorectal surgery without Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery [laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others] under conventional protocol. Control 2: Open colorectal surgery defined as patients undergoing open laparotomy for colorectal surgery [open right / left hemicolectomy, open low anterior resection, open abdominoperineal resection (APR) and others].
Who may be able to join
- Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data.
Who cannot join
- 1. Patients with incomplete required data on record.
- 2. Those with any major intraoperative or postoperative complications.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Sasikaan Nimmaanrat
Hat Yai, Changwat Songkhla, 90110
Sasikaan Nimmaanrat, MD, snimmaanrat@yahoo.com.au
About this study
This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.
Read the detailed description
This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).
- Conditions
- Postoperative Pain
- Being tested
- Celecoxib
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Patients in ERAS group received celecoxib
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Patients undergoing laparoscopic colorectal surgery with ERAS Receives: Drug: Celecoxib | |
| Non ERAS | Patients undergoing laparoscopic colorectal surgery without ERAS | |
| Open | Patients undergoing open colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain score (Verbal Numerical Rating Scale: VNRS) after surgery, VNRS consists of 0-10, where 0 means no pain and 10 means worst pain imaginable
Measured: Until discharge (5-7 days)
Secondary outcomes (1)
Opioid
Amount of postoperative opioid consumption
Measured: Until discharge (5-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997174
- Sponsor's protocol ID
- REC.64-290-8-1
- Status last verified
- Oct 2021
- First submitted
- 30 Jul 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share upon request
Publications
Tan SJ, Zhou F, Yui WK, Chen QY, Lin ZL, Hu RY, Gao T, Li N. Fast track programmes vs. traditional care in laparoscopic colorectal surgery: a meta-analysis of randomized controlled trials. Hepatogastroenterology. 2014 Jan-Feb;61(129):79-84.
PubMed 24895798
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04997174
- Acronym / sponsor ID
- REC.64-290-8-1
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Aug 2021 (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.
This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.
Detailed description
This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ERAS | – | Drug: CelecoxibPatients undergoing laparoscopic colorectal surgery with ERAS |
| Non ERAS | – | –Patients undergoing laparoscopic colorectal surgery without ERAS |
| Open | – | –Patients undergoing open colorectal surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group of interest: Laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery [laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others] under ERAS protocol. Control 1: Laparoscopic colorectal surgery without Enhanced Recovery after Surgery (ERAS) program defined as patients undergoing laparoscopic colorectal surgery [laparoscopic right / left hemicolectomy, laparoscopic low anterior resection, laparoscopic abdominoperineal resection (APR) and others] under conventional protocol. Control 2: Open colorectal surgery defined as patients undergoing open laparotomy for colorectal surgery [open right / left hemicolectomy, open low anterior resection, open abdominoperineal resection (APR) and others].
Key inclusion criteria (1 listed)
- Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data.
Key exclusion criteria (2 listed)
- 1. Patients with incomplete required data on record.
- 2. Those with any major intraoperative or postoperative complications.
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 |
|---|---|---|
| CelecoxibPatients in ERAS group received celecoxib | Drug | ERAS |
Primary outcome
Pain intensity
Time frame: Until discharge (5-7 days)
Pain score (Verbal Numerical Rating Scale: VNRS) after surgery, VNRS consists of 0-10, where 0 means no pain and 10 means worst pain imaginable
1 secondary outcome
Opioid
Time frame: Until discharge (5-7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Results publication: PubMed 24895798Tan SJ, Zhou F, Yui WK, Chen QY, Lin ZL, Hu RY, Gao T, Li N. Fast track programmes vs. traditional care in laparoscopic colorectal surgery: a meta-analysis of randomized controlled trials. Hepatogastroenterology. 2014 Jan-Feb;61(129):79-84.
- Individual participant dataSharing planned: Undecided. Share upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Prince of Songkla University at 1 site in Thailand.
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 1 inclusion and 2 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 Oct 2021. 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 Thailand. 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 Sasikaan Nimmaanrat, MD (+66887907842, snimmaanrat@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Until discharge (5-7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997174, which also lists 1 linked publication.
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 Oct 2021.