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Effect of Warmed Humidified CO2 on Peritoneum During Laparotomy

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ClinicalTrials.gov Identifier: NCT02975947
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Ju Yong Cheong, Concord Repatriation General Hospital

Brief Summary:

The operating theatre is deliberately made to be cold and dry to prevent bacteria from growing. The problem with this is that during open abdominal surgery, the intestine and the overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum from drying by applying warmed saline packs periodically to the bowel. However, this is not always possible. Sometimes, the surgeon has to perform an important component of the procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries. When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel obstruction. This vicious cycle is repeated when the patient undergoes repetitive open abdominal operations.

This study aimed to be the first human study to:

  1. Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is increased for pro-inflammatory cytokines. This study also aim to show that proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using Western Blotting) are elevated during the course of the operation.
  2. Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to the bowel/peritoneum drying (dessication).

This study will attempt to prove this by using humidified, warmed carbon dioxide gas which will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the peritoneal injury and the inflammation. The investigators will attain peritoneal samples during open colorectal operations. The investigators will obtain samples at the beginning and end of the operation. This study design is a randomized controlled trial, where half the patients will receive humidified, warmed carbon dioxide gas during surgery, and the other half will get standard open surgery without carbon dioxide. 40 patients will be recruited in this study. Half (20) will get CO2, and other half (20) will get standard open surgery.


Condition or disease Intervention/treatment Phase
Peritoneal Inflammation Peritoneum; Injury Device: Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) Device: Standard heating Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
Study Start Date : August 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.
Device: Standard heating
Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head

Experimental: Study Group
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide delivered into the open peritoneal cavity.
Device: Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide into the open peritoneal cavity using the Fisher & Paykel's HUMIGARD system (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand). This will create a local atmosphere of 100% carbon dioxide (warmed, humidified) in the open peritoneal cavity.




Primary Outcome Measures :
  1. Change in Inflammatory cytokine level in the peritoneal biopsy samples [ Time Frame: At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened) ]
    Peritoneal samples will be taken when the peritoneal cavity is being opened (at beginning of operation), and also when the peritoneal cavity is being closed (at end of the operation). The change in the level of inflammatory cytokines in between these two time points will be measured

  2. Intraoperative temperature at 30 minutes from start of operation [ Time Frame: 30 minutes from start of operation ]
    Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.

  3. Intraoperative temperature at 60 minutes from start of operation [ Time Frame: 60 minutes from start of operation ]
    Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.


Secondary Outcome Measures :
  1. Postoperative Analgesia requirement for pain [ Time Frame: Time from when the patient is moved out of operating theater to when the patient is no longer an inpatient in the hospital ward (discharged), with an expected average of 1 week ]
    Postoperative pain as measured by MEDD (Morphine Equivalent Daily Dose)

  2. Length of in-patient hospital stay [ Time Frame: duration of hospital stay, an expected average of 1 week ]
    number of days patient stayed postoperatively in hospital

  3. Anastomotic leaks [ Time Frame: 6 months ]
    The occurrence of anastomotic leak in the 6 months after the surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults above age 18.
  • Elective patients.
  • Pathologies: colorectal carcinoma, polyposis syndromes, diverticular diseases, prolapses, and patients with inflammatory bowel disease undergoing elective resection.
  • For colorectal carcinoma, all patients whether they are having curative or palliative surgery will be included.
  • Patients undergoing open elective colectomy, with or without stoma formation/ bowel anastomosis.

Exclusion Criteria:

  • Patients undergoing acute surgery (emergency surgery).
  • Patients undergoing Laparoscopic colectomy (multiport, single incision and also hand assisted) as all these patients receive heated humidified CO2.
  • For COPD patients, the exclusion criteria would be patients: (1) On home oxygen, (2) Type 2 respiratory failure (CO2 retainers) (3) FEV1<1L, or FEV1/FVC <50% of predicted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975947


Locations
Australia, New South Wales
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2138
Sponsors and Collaborators
Concord Repatriation General Hospital

Publications of Results:

Responsible Party: Dr Ju Yong Cheong, Doctor, Concord Repatriation General Hospital
ClinicalTrials.gov Identifier: NCT02975947     History of Changes
Other Study ID Numbers: HREC/12/CRGH/196
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Peritonitis
Pathologic Processes
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases