Effect of Warmed Humidified CO2 on Peritoneum During Laparotomy

NCT02975947 | Completed

• 1 other identifier: HREC/12/CRGH/196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to the bowel/peritoneum drying (dessication).

Conditions

Peritoneal Inflammation; Peritoneum; Injury

Outcome Measures

Primary Outcomes (3)

• Change in Inflammatory cytokine level in the peritoneal biopsy samples

  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

  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)

• Intraoperative temperature at 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.

  30 minutes from start of operation

• Intraoperative temperature at 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.

  60 minutes from start of operation

Secondary Outcomes (3)

• Postoperative Analgesia requirement for pain

  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

• Length of in-patient hospital stay

  duration of hospital stay, an expected average of 1 week

• Anastomotic leaks

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.

Device: Standard heating

Study Group

EXPERIMENTAL

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)

Interventions

Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) DEVICE

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.

Study Group

Standard heating DEVICE

Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concord Repatriation General Hospital: lead

Study Sites (1)

Concord Repatriation General Hospital

Sydney, New South Wales, 2138, Australia

Location

Related Publications (24)

• Persson M, van der Linden J. Intraoperative CO2 insufflation can decrease the risk of surgical site infection. Med Hypotheses. 2008;71(1):8-13. doi: 10.1016/j.mehy.2007.12.016. Epub 2008 Mar 4.

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• Persson M, van der Linden J. Can wound desiccation be averted during cardiac surgery? An experimental study. Anesth Analg. 2005 Feb;100(2):315-320. doi: 10.1213/01.ANE.0000140243.97570.DE.

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• Persson M, Elmqvist H, van der Linden J. Topical humidified carbon dioxide to keep the open surgical wound warm: the greenhouse effect revisited. Anesthesiology. 2004 Oct;101(4):945-9. doi: 10.1097/00000542-200410000-00020.

  PMID: 15448528 RESULT

• Persson M, Svenarud P, Flock JI, van der Linden J. Carbon dioxide inhibits the growth rate of Staphylococcus aureus at body temperature. Surg Endosc. 2005 Jan;19(1):91-4. doi: 10.1007/s00464-003-9334-z. Epub 2004 Nov 11.

  PMID: 15529188 RESULT

• Persson M, van der Linden J. Wound ventilation with ultraclean air for prevention of direct airborne contamination during surgery. Infect Control Hosp Epidemiol. 2004 Apr;25(4):297-301. doi: 10.1086/502395.

  PMID: 15108726 RESULT

• Svenarud P, Persson M, Van Der Linden J. Efficiency of a gas diffuser and influence of suction in carbon dioxide deairing of a cardiothoracic wound cavity model. J Thorac Cardiovasc Surg. 2003 May;125(5):1043-9. doi: 10.1067/mtc.2003.50.

  PMID: 12771877 RESULT

• Svenarud P, Persson M, van der Linden J. Intermittent or continuous carbon dioxide insufflation for de-airing of the cardiothoracic wound cavity? An experimental study with a new gas-diffuser. Anesth Analg. 2003 Feb;96(2):321-7, table of contents. doi: 10.1097/00000539-200302000-00005.

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• Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.

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  PMID: 19258346 RESULT

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  PMID: 19020142 RESULT

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  PMID: 18639246 RESULT

• Brokelman WJ, Holmdahl L, Bergstrom M, Falk P, Klinkenbijl JH, Reijnen MM. Heating of carbon dioxide during insufflation alters the peritoneal fibrinolytic response to laparoscopic surgery : A clinical trial. Surg Endosc. 2008 May;22(5):1232-6. doi: 10.1007/s00464-007-9597-x. Epub 2007 Oct 18.

  PMID: 17943363 RESULT

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  PMID: 9823923 RESULT

• Moehrlen U, Ziegler U, Boneberg E, Reichmann E, Gitzelmann CA, Meuli M, Hamacher J. Impact of carbon dioxide versus air pneumoperitoneum on peritoneal cell migration and cell fate. Surg Endosc. 2006 Oct;20(10):1607-13. doi: 10.1007/s00464-005-0775-4. Epub 2006 Jul 3.

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  PMID: 15836853 RESULT

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  PMID: 31348 RESULT

• Ott DE. Correction of laparoscopic insufflation hypothermia. J Laparoendosc Surg. 1991 Aug;1(4):183-6. doi: 10.1089/lps.1991.1.183.

  PMID: 1834266 RESULT

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  PMID: 8457047 RESULT

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  PMID: 8569362 RESULT

• Hazebroek EJ, Schreve MA, Visser P, De Bruin RW, Marquet RL, Bonjer HJ. Impact of temperature and humidity of carbon dioxide pneumoperitoneum on body temperature and peritoneal morphology. J Laparoendosc Adv Surg Tech A. 2002 Oct;12(5):355-64. doi: 10.1089/109264202320884108.

  PMID: 12470410 RESULT

• Cheong JY, Chami B, Fong GM, Wang XS, Keshava A, Young CJ, Witting P. Randomized clinical trial of the effect of intraoperative humidified carbon dioxide insufflation in open laparotomy for colorectal resection. BJS Open. 2020 Feb;4(1):45-58. doi: 10.1002/bjs5.50227. Epub 2019 Nov 17.

  PMID: 32011809 DERIVED

MeSH Terms

Conditions

Peritonitis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 29, 2016
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)