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

Colonic motility distal to a deviating ileostomy after rectal resection and construction of a primary anastomosis - COLO-MOVE study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43557
Enrollment
39
Registered
2015-09-29
Start date
2015-11-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer rectal carcinoma

Interventions

None listed

Sponsors

Meander Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
niet van toepassing

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)