NCT05784493

Brief Summary

The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

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, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 2, 2023

Last Update Submit

March 13, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain assessed by visual analog scale

    To assess postoperative pain incidence by using visual analog scale

    5 months

Study Arms (2)

Washing by heated saline group

EXPERIMENTAL
Other: Study group

Washing by normal room temperature saline group

ACTIVE COMPARATOR
Other: Study group

Interventions

Study groupOTHER

Washing by heated saline group

Washing by heated saline groupWashing by normal room temperature saline group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all of cases that had laparoscopic hysterectomy for bening conditions

You may not qualify if:

  • maling cases
  • conversion to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pirincipal İnvestigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 27, 2023

Study Start

July 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

TU(1)