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Completed

NCT Number: NCT04449822

Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions

The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tbilisi State Medical University

Tbilisi, Yes, 0159, Georgia

About this study

Acute colonic obstruction is one of the common clinical presentations of colorectal cancer. Surgical decompression with colostomy with or without resection and eventual re-anastomosis is the treatment of choice; however, emergency surgery is associated with higher morbidity and mortality.

The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed surgery to be performed electively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with malignant colorectal obstructions.
  • Patient's approval to participate in the study.

Exclusion criteria

  • Patient's preference for either treatment method.
  • Patient's refusal to participate in the study.
  • Patients in the ASA group 4 and 5.

Treatment and study plan

Emergency surgery

Procedure

Surgical decompression with colostomy with or without resection and eventual re-anastomosis.

Colonic stenting

Procedure

The colonic stent placement to relieve the colonic obstruction.

Primary outcomes

  1. The time of clinical relieve of obstruction

    Time frame: 24 hours after surgery/procedure

Secondary outcomes

  1. Stent related complications

    Time frame: time of hospital stay, an average 10 day.

    perforation, migration, stent obstruction

  2. Mortality

    Time frame: 30 day after surgery/procedure

    30-day mortality

  3. Blood loss

    Time frame: time of surgery/procedure

    Blood loss during emergency surgery or during colonic stenting.

  4. operation time

    Time frame: during surgery/procedure

    duration of surgery/procedure

  5. Overall complications

    Time frame: 30 day after surgery/procedure

    complications which developed in postoperative period

Sponsors and collaborators

Lead sponsor

Zaza Demetrashvili

Other

Registry information

Official study title

Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jun 29, 2020
Registry last updated
May 2, 2022

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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