NCT03623399

Brief Summary

Aim of the study is to determine the effect of different laparoscopic intraoperative intraabdominal gas (CO2) pressures on the extent of postoperative pain scores.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 5, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 5, 2018

Last Update Submit

August 8, 2018

Conditions

Keywords

postoperative painIntraabdominal laparoscopic gas pressure

Outcome Measures

Primary Outcomes (1)

  • postoperative pain scores

    Difference between pain scores of participitants according to differing gas pressures applied.

    Postoperative 6 th hour

Study Arms (3)

15 mmhg-15mmhg

NO INTERVENTION

Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 15 mmhg.

15 mmhg-12 mmhg

OTHER

Abdominal entrance pressure will be set to 15 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy

Procedure: low gas pressure laparoscopy

12 mmhg-12 mmhg

OTHER

Abdominal entrance pressure will be set to 12 mmhg , after laparoscopic visualization of abdomen ; maintenance pressure will be set to 12 mmhg. Low gas pressure laparoscopy

Procedure: low gas pressure laparoscopy

Interventions

To apply different CO2 entrance and intraoperative pressures

12 mmhg-12 mmhg15 mmhg-12 mmhg

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • benign gynecologic pathologies which requires laparoscopic surgery

You may not qualify if:

  • patients who has malign gynecologic pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Yuksel Simsek

Adana, 001, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Koc M, Ertan T, Tez M, Kocpinar MA, Kilic M, Gocmen E, Aslar AK. Randomized, prospective comparison of postoperative pain in low- versus high-pressure pneumoperitoneum. ANZ J Surg. 2005 Aug;75(8):693-6. doi: 10.1111/j.1445-2197.2005.03496.x.

    PMID: 16076335BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Husnu Celık, Prof.

    Baskent University

    STUDY CHAIR

Central Study Contacts

Seda YUKSEL SIMSEK, M.D.

CONTACT

Erhan SIMSEK, Ass. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gynecology Specialist

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 9, 2018

Study Start

August 7, 2018

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations