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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02997267
Other study ID # Zespolenia
Secondary ID
Status Completed
Phase N/A
First received December 5, 2016
Last updated March 31, 2018
Start date October 2016
Est. completion date December 31, 2017

Study information

Verified date March 2018
Source Stanley Dudrick's Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to compare the restoration of the GI tract by the closure of protective ileostomy after low anterior resection for rectal cancer after 14 days and more than 3 months.


Description:

The closure of the protective ileostomy created during the low anterior resection for rectal cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the gastrointestinal tract. It usually takes place several months after the primary surgery, because the patients starts chemotherapy and cannot undergo the procedure during the therapy. It results in the relative low quality of life of the patient, as well as often leads to complications. Therefore, it seem reasonable to close the stoma as soon as possible to take the burden off patient.

It is well known that the healing process of the anastomosis runs in the three phases, but only two first are crucial for the clinical result. The second takes place between 5th and 14th postoperative day. Therefore it should be possible to perform successful restoration of the GI tract already after two weeks after operation, and not after many moths.

The aim of the study was to compare the restoration of the GI tract after 14 days and more than 3 months, so to compare the traditional and early strategy.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 31, 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- more than 18 year old

- the presence of the protective ileostomy created during the low anterior resection to protect the colo-rectal anastomosis

Exclusion Criteria:

- the presence of the protective ileostomy created during any other procedure than the low anterior resection to protect the colo-rectal anastomosis

- age < 18 yo

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Closure of the ileostomy
Surgical closure of the protective ileostomy (reconnection of intestinal loops)

Locations

Country Name City State
Poland Stanley Dudrick's Memorial Hospital Skawina

Sponsors (1)

Lead Sponsor Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of postoperative fistulas number of patients with the fistula of the anastomosis 3 months after surgery
Secondary Timing of anticancer therapy Time to the beginning of adiuvant chemotherapy 3 months after surgery
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