Laparoscopic Gas Pressure and Postoperative Pain Score
Does Laparoscopic Entrance and Intraoperative Intraabdominal Gas Pressure Effect Postoperative Pain Score
1 other identifier
interventional
195
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2018
CompletedStudy Start
First participant enrolled
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedAugust 9, 2018
August 1, 2018
7 months
August 5, 2018
August 8, 2018
Conditions
Keywords
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 INTERVENTIONAbdominal 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
OTHERAbdominal 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
12 mmhg-12 mmhg
OTHERAbdominal 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
Interventions
To apply different CO2 entrance and intraoperative pressures
Eligibility Criteria
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)
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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Husnu Celık, Prof.
Baskent University
Central Study Contacts
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