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

October 9, 2021 updated by: Sasikaan Nimmaanrat, Prince of Songkla University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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].

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1. Patients with incomplete required data on record.
  • 2. Those with any major intraoperative or postoperative complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERAS
Patients undergoing laparoscopic colorectal surgery with ERAS
Drug: Celecoxib
Patients in ERAS group received celecoxib
Non ERAS
Patients undergoing laparoscopic colorectal surgery without ERAS
Open
Patients undergoing open colorectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until discharge (5-7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid
Time Frame: Until discharge (5-7 days)
Amount of postoperative opioid consumption
Until discharge (5-7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (ACTUAL)

August 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC.64-290-8-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Share upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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