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

NCT04997174 | Unknown DMC

• 1 other identifier: REC.64-290-8-1
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Until discharge (5-7 days)

Secondary Outcomes (1)

• Opioid

  Until discharge (5-7 days)

Study Arms (3)

ERAS

Patients undergoing laparoscopic colorectal surgery with ERAS

Drug: Celecoxib

Non ERAS

Patients undergoing laparoscopic colorectal surgery without ERAS

Open

Patients undergoing open colorectal surgery

Interventions

Celecoxib DRUG

Patients in ERAS group received celecoxib

ERAS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 \[open right / left hemicolectomy, open low anterior resection, open abdominoperineal resection (APR) and others\].

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Sasikaan Nimmaanrat

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 24895798 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sasikaan Nimmaanrat, MD

CONTACT

+66887907842; snimmaanrat@yahoo.com.au

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

TH (1)