Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery (ELOPES Study)
NCT ID: NCT03179111
Last Updated: 2018-05-07
Study Results
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Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2017-08-30
2018-05-04
Brief Summary
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Detailed Description
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Towards the end of the surgery, all residual pneumoperitoneum will be evacuated by keeping the trocar valves open under direct telescopic vision. The duration of surgery or any intraoperative complications will be recorded. The starting of surgery will be regarded after the induction of anaesthesia and the end of surgery is regarded when the end of skin closure. Operating field or also known as surgical view is defined as the view of the intra-abdomen. A clear operating field allows a good working space for the surgeon. Numeric rating score will be used to access the operating field during the surgery. Post-operative pain will be rated on a Visual Analog Scale at rest and with movement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low Pressure Group
Participants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 8-10mmHg. The number of subjects anticipated for this arm will be 47. Participants in this low pressure group are expected to encounter lesser shoulder tip pain and abdominal pain. Operating field for surgeons also expected to be better.
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.
Standard Pressure Group
Participants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 12-15mmHg. The number of subjects anticipated for this arm will be 47. Participants in this group are expected to have an increased amount of shoulder tip pain and higher pain score postoperatively compared to low pressure group. Operating fields for surgeons are expected to be less clear.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Patients who are approved by the anaesthetics to undergo bariatric surgery.
Exclusion Criteria
* Inability to give informed consent
* Patient unfit for bariatric surgery including who has poor respiratory, cardiac, renal and liver function.
* Patient with Body Mass Index (BMI) \>50
* Patient with American Society of Anesthesiologists (ASA) \>3
18 Years
70 Years
ALL
No
Sponsors
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Universiti Putra Malaysia
OTHER
Responsible Party
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Dr. Tikfu Gee
Principle Investigator
Locations
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Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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References
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Other Identifiers
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NMRR-16-1488-32135 (IIR)
Identifier Type: -
Identifier Source: org_study_id
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