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Pain After Laparoscopic Hysterectomy

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Study group

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: all of cases that had laparoscopic hysterectomy for bening conditions Exclusion Criteria: maling cases conversion to laparotomy

Sites / Locations

Namik Kemal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Washing by heated saline group

Washing by normal room temperature saline group

Arm Description

Outcomes

Primary Outcome Measures

Pain assessed by visual analog scale

To assess postoperative pain incidence by using visual analog scale

Secondary Outcome Measures

Full Information

NCT ID

NCT05784493

First Posted

March 2, 2023

Last Updated

March 13, 2023

Sponsor

Namik Kemal University

Collaborators

Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın

1. Study Identification

Unique Protocol Identification Number

NCT05784493

Brief Title

Pain After Laparoscopic Hysterectomy

Official Title

The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Namik Kemal University

Collaborators

Fırat Can Sogut, Ozlem Sevinc Ergul, Mehmet Veysel Arın

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Washing by heated saline group

Arm Type

Experimental

Arm Title

Washing by normal room temperature saline group

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Study group

Intervention Description

Washing by heated saline group

Primary Outcome Measure Information:

Title

Pain assessed by visual analog scale

Description

To assess postoperative pain incidence by using visual analog scale

Time Frame

5 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all of cases that had laparoscopic hysterectomy for bening conditions Exclusion Criteria: maling cases conversion to laparotomy

Facility Information:

Facility Name

Namik Kemal University

City

Tekirdag

Country

Turkey

12. IPD Sharing Statement

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Pain After Laparoscopic Hysterectomy

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