Pain After Laparoscopic Hysterectomy | NCT05784493

Studies
Pain After Laparoscopic Hysterectomy

NCT05784493

Sponsor

Namik Kemal University

Status

Completed

Last Update Posted

Mar 27, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Study group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Mar 2, 2023

First Submission Date that Met QC Criteria

Mar 13, 2023

First Posted Date

Mar 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Baki Senturk, Pirincipal İnvestigator, Namik Kemal UniversityPrincipal Investigator

Lead Sponsor

Namik Kemal UniversityOTHER

Collaborators

Name	Class
Fırat Can Sogut	UNKNOWN
Ozlem Sevinc Ergul	UNKNOWN
Mehmet Veysel Arın	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain.

This study is double blind randomized controlled study.

inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition

exclusion criteria: maling cases and conversion to laparotomy

after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Washing by heated saline group	Experimental		Other: Study group
Washing by normal room temperature saline group	Active Comparator		Other: Study group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study group	Other	Washing by heated saline group	Washing by heated saline group Washing by normal room temperature saline group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessed by visual analog scale	To assess postoperative pain incidence by using visual analog scale	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all of cases that had laparoscopic hysterectomy for bening conditions

Exclusion Criteria:

maling cases
conversion to laparotomy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Namik Kemal University		Tekirdağ			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

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Browse Branches

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