Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery (ELOPES Study)

NCT03179111 | Completed

• 1 other identifier: NMRR-16-1488-32135 (IIR)
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Operating Field

  Numeric rating score will be used to access the operating field during the surgery. The numeric rating score will be recorded after the surgery by the surgeon. The score ranges from 1 to 4 whereby 1 means poor space with excessive muscular contractions and unable to proceed with surgery safely. Numeric rating scale of 4 indicates good surgical space. If there was any compromise of the operating field (NOS score ≥ 3), the pneumoperitoneum pressure will be increased accordingly.

  It will be assessed intraoperatively (during the surgery).

Secondary Outcomes (2)

• Pain Score

  The abdomen and shoulder tip pain intensity will be rated up to 48 hours postoperatively.

• Duration of Surgery

  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.

Study Arms (2)

Low Pressure Group

EXPERIMENTAL

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.

Procedure: Pneumoperitoneum Pressure

Standard Pressure Group

EXPERIMENTAL

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.

Procedure: Pneumoperitoneum Pressure

Interventions

Pneumoperitoneum Pressure PROCEDURE

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.

Low Pressure Group; Standard Pressure Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Ability to give informed consent
• Patients who are approved by the anaesthetics to undergo bariatric surgery.

You may not qualify if:

• Age below 18 and above 70
• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Related Publications (37)

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MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double blind study. Neither the participant (patient) nor the investigator (surgeon) will know which group the particular participant will be assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: There will be two arms in this study. One arm will be the low pressure pneumoperitoneum group (8-10mmHg) where else the other arm will be the standard pressure pneumoperitoneum group (12-15mmHg).

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 7, 2017
• Study Start: August 30, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

MY (1)