Colonic motility distal to a deviating ileostomy after rectal resection and construction of a primary anastomosis

• Conditions: 10002112; rectal cancer; rectal carcinoma; 10017991

• Registration Number: NL-OMON43557
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

- Age >50 years
- Established diagnosis of rectal carcinoma (confirmed by MRI and/or colonoscopy).
- Indication for rectal resection with construction of a primary anastomosis (indication determined by the treating surgeon)
- Construction of a deviating ileostomy
- Surgery performed in an elective setting
- Signed informed consent
- Preoperative bowel preparation using an enema (according to standard protocol)

Exclusion Criteria

- Not able to sign informed consent
- Previous colonic resection in medical history
- Known gastro-intestinal motility disorder, such as slow-transit colon, diabetic gastro-paresis etc.
- Allergy for gelatin or plastic; the radiopaque markers contain both substances
- Pregnancy
- Contra-indications for the use of either a rectal enema.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is colon motility distal to the deviating ileostomy in the<br /><br>early postoperative phase, which will be measured using colonic radiopaque<br /><br>markers (Sitzmarks®). We expect motility to be absent or minimal. In addition,<br /><br>the number of clinically relevant anastomotic leakages and other complications<br /><br>will be documented.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>niet van toepassing</p><br>