Peritoneal Inflammation Clinical Trial
Official title:
Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | Concord Repatriation General Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Concord Repatriation General Hospital |
Australia,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | Postoperative Analgesia requirement for pain | Postoperative pain as measured by MEDD (Morphine Equivalent Daily Dose) | 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 | No |
Secondary | Length of in-patient hospital stay | number of days patient stayed postoperatively in hospital | duration of hospital stay, an expected average of 1 week | No |
Secondary | Anastomotic leaks | The occurrence of anastomotic leak in the 6 months after the surgery | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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