PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

Rectal Cancer Clinical Trial

— PROTECT  

Official title:

Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357171
• Other study ID #: 5
• Status: Completed
• Phase: N/A
• Start date: January 14, 2012
• Est. completion date: February 2, 2020

Study information

• Verified date: April 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate.

This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

Description:

Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence.

The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue.

The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity.

In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages.

Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Mid- and low rectal cancer

• Age ? 18

• TME

• ASA ? 3

• No previous stoma formation

• Informed consent for participation

Exclusion Criteria:

• Patients lost during the follow-up

• Refusal of the patient from further participation in the study

• Inability of stoma formation

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Low anterior resection with protective loop ileostomy
Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.
• Low anterior resection with protective loop transverse colostomy
Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of readmissions due to severe dehydratation	The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting	6 weeks
Secondary	Early postoperative complications rate	The rate of all postoperative complications in early postoperative period after resectional surgery	30 days after the initial procedure
Secondary	Late postoperative complications rate	The rate of all postoperative complications	starting on 31st day and within 6 months in late postoperative period after the initial procedure
Secondary	Overall quality of life	Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability	6 and 12 months after the initial procedure
Secondary	Time with stoma	The period of time between initial resectional procedure and closure of protetctive stoma only in patients who had their intestinal stoma reversed	5 years
Secondary	The rate of early postoperative complications after stoma closure operation	The rate of early postoperative complications after stoma closure operation	3 months after stoma closure