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OpenTrials
Completed

NCT Number: NCT04169425

Laparoscopic Surgery of Rectal Cancer and Ileostomy

Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.

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Key information

Conditions

Ileostomy - Stoma Anastomotic Leak Ileostomy; Complications Leakage, Anastomotic Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

67 year–86 year

Sex eligibility

All sexes

Study type

Observational

About this study

From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients (aged 18 years and over)
  • patients submitted to elective Anterior Rectal Resection

Exclusion criteria

  • chronic use of immunosuppressant agents
  • urgent surgery

Treatment and study plan

elective diverting ileostomy

Procedure

Primary outcomes

  1. Number of participants with anastomotic leakage

    Time frame: 90 days

    Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema

Secondary outcomes

  1. Number of participants with post-operative complications

    Time frame: 90 days

    post-operative complication in patients submitted to Anterior Rectal Resection

  2. Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever

    Time frame: 90 days

    post-operative fever in patients submitted to Anterior Rectal Resection

  3. Number of participants with surgical site infection

    Time frame: 90 days

    post-operative surgical site infection in patients submitted to Anterior Rectal Resection

  4. Number of participants with abdominal collections

    Time frame: 90 days

    post-operative abdominal collections in patients submitted to Anterior Rectal Resection

  5. Number of participants with anastomotic bleeding

    Time frame: 90 days

    post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection

  6. Number of participants with perforation

    Time frame: 90 days

    post-operative perforation in patients submitted to Anterior Rectal Resection

  7. Number of participants with anastomotic stenosis

    Time frame: 90 days

    post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
Nov 21, 2019

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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