Early Closure of Protective Ileostomy in Rectal Cancer Patients

Ileostomy - Stoma Clinical Trial

— ECPIS  

Official title:

The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997267
• Other study ID #: Zespolenia
• 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
• 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

Related Conditions & MeSH terms

• Ileostomy - Stoma

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