NCT04953182

Brief Summary

Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences. The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

4.5 years

First QC Date

June 26, 2021

Last Update Submit

July 3, 2021

Conditions

Keywords

Pain killers

Outcome Measures

Primary Outcomes (2)

  • Pain medition

    The pain registred is analyze as maximum, mean and on discharge.

    Immediately after the intervention/procedure/surgery

  • Drugs Administred

    The amount of drugs administred to each patients is analyzed

    Immediately after the intervention/procedure/surgery

Study Arms (2)

Around the clock analgetic treatment

Patients that underwent hemorrhoidectomy and pain killers are prescribed every specific hour independent of pain degree, if necessary drugs can be administered on demand.

Other: Pain scale registry

On demand analgetic treatment

A pain killers list is prescribed by the physician and the nurse decides which drug to administer depending on a protocol of treatment based on the visual analog scale.

Other: Pain scale registry

Interventions

The nurses ask the patient about the pain filling every two hours during the hospitalization.

Around the clock analgetic treatmentOn demand analgetic treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent elective hemorrhoidectomy

You may qualify if:

  • Elective surgery for hemorrhoids

You may not qualify if:

  • Mental retardation Incapacitated patient Under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Susmallian S, Aviv I, Babis I, Segal E. Analysis of Two Treatment Modalities for Post-surgical Pain after Hemorrhoidectomy. Chirurgia (Bucur). 2024 Jun;119(3):247-259. doi: 10.21614/chirurgia.2024.v.119.i.3.p.247.

MeSH Terms

Conditions

Acute PainPain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sergio G Susmallian, MD

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of general surgery

Study Record Dates

First Submitted

June 26, 2021

First Posted

July 7, 2021

Study Start

July 1, 2016

Primary Completion

December 31, 2020

Study Completion

May 30, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

The data will be sent to the accepting journal study