Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-01-22

Brief Summary

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The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

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Detailed Description

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After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.

Conditions

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Pneumoperitoneum Pain Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

none of the participants knew at which pressure they will be operated on, nor the physicians who followed participants at floor or those analyzing blood samples, not the assigned physician to collect data, nor the personnel doing the analysis.

only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.

Study Groups

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Low-pressure

Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Group Type EXPERIMENTAL

low-pressure pneumoperitoneum

Intervention Type PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg

Standard-pressure

Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg

Group Type ACTIVE_COMPARATOR

standard-pressure pneumoperitoneum

Intervention Type PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Interventions

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low-pressure pneumoperitoneum

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg

Intervention Type PROCEDURE

standard-pressure pneumoperitoneum

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective admission for laparoscopic cholecystectomy

Exclusion Criteria

* Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
* previous GI surgeries, except bariatric and anti-reflux surgeries
* Currently on immunosuppressant agents
* Pregnancy
* Breastfeeding
* Currently diagnosed with drug addiction
* American Society of Anesthesiologists (ASA) score 3 and more

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No