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Completed

NCT Number: NCT04357171

PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low anterior resection with protective loop ileostomy

Procedure

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

Procedure

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.

Primary outcomes

  1. The rate of readmissions due to severe dehydratation

    Time frame: 6 weeks

    The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting

Secondary outcomes

  1. Early postoperative complications rate

    Time frame: 30 days after the initial procedure

    The rate of all postoperative complications in early postoperative period after resectional surgery

  2. Late postoperative complications rate

    Time frame: starting on 31st day and within 6 months in late postoperative period after the initial procedure

    The rate of all postoperative complications

  3. Overall quality of life

    Time frame: 6 and 12 months after the initial procedure

    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

  4. Time with stoma

    Time frame: 5 years

    The period of time between initial resectional procedure and closure of protetctive stoma only in patients who had their intestinal stoma reversed

  5. The rate of early postoperative complications after stoma closure operation

    Time frame: 3 months after stoma closure

    The rate of early postoperative complications after stoma closure operation

Sponsors and collaborators

Lead sponsor

Russian Society of Colorectal Surgeons

Other

Registry information

Official study 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

Acronym: PROTECT

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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