Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer

Bacterium-Related Malignant Neoplasm Clinical Trial

Official title:

Peritoneal Bacterial Contamination With Closed or Open Rectal Stump

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527382
• Other study ID #: 23937
• Status: Completed
• Phase: N/A
• First received: August 16, 2015
• Last updated: August 17, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Bucharest Emergency Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.

Description:

There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.

Exclusion Criteria:

• Patients without informed consent

• Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score

• Patient with prior peritonitis

• Patients with acute inflammatory bowel disease

• Recent antibiotic treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Bacterium-Related Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Closed stump
Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a bowel clamp is placed on the rectal stump. A second bacterial sample is obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florin Iordache

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Colony-Forming Units (CFU)/ml from the peritoneal samples	The formula we will use is: number of CFU (colony forming units)/ml = n x 10 x d, where n = number of colonies on the media and d = dilution reverse. The final number of CFU/ml will be given as the arithmetic mean of the three dilutions done for each sample. When no bacterial growth is found the results are given as 0 CFU/ml. The maximum limit is considered 100,000 CFU/ml.	within the first 30 days after surgery	No