Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery (ELOPES Study)
NCT03179111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2018-05-07
Summary
This is a prospective study whereby it involves patients who are planned for bariatric surgery. In the bariatric surgery procedure, pneumoperitoneum pressure will be the experimental aspect in this study. The pneumoperitoneum pressure will be adjusted to either 8-10 mmHg of low pressure or to 12-15mmHg of standard pressure.
Conditions
- Surgical View
- Shoulder Tip Pain
- Abdominal Pain
Interventions
- PROCEDURE
-
Pneumoperitoneum Pressure
There will be two arms in this study. The participants recruited for this study are those who have been screened and planned for elective bariatric surgery.The pneumoperitoneum pressure will be adjusted to either 8-10mmHg or 12-15mmHg until a clear operating field is obtained by the surgeon. Low pneumoperitoneum pressure has been expected to give a clearer and better surgical view than standard pneumoperitoneum pressure. Participants under the low pressure group are expected to have lesser pain score on abdominal pain and shoulder tip pain as compared to participants in the standard pressure group.
Sponsors & Collaborators
-
Universiti Putra Malaysia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-30
- Primary Completion
- 2018-05-04
- Completion
- 2018-05-04
Countries
- Malaysia
Study Locations
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