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Laparoscopic Surgery of Rectal Cancer and Ileostomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04169425
Enrollment
150
Registered
2019-11-19
Start date
2012-01-02
Completion date
2018-02-01
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy; Complications, Ileostomy - Stoma, Leakage, Anastomotic

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREelective diverting ileostomy

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
67 Years to 86 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with anastomotic leakage90 daysLeakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema

Secondary

MeasureTime frameDescription
Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever90 dayspost-operative fever in patients submitted to Anterior Rectal Resection
Number of participants with surgical site infection90 dayspost-operative surgical site infection in patients submitted to Anterior Rectal Resection
Number of participants with abdominal collections90 dayspost-operative abdominal collections in patients submitted to Anterior Rectal Resection
Number of participants with post-operative complications90 dayspost-operative complication in patients submitted to Anterior Rectal Resection
Number of participants with perforation90 dayspost-operative perforation in patients submitted to Anterior Rectal Resection
Number of participants with anastomotic stenosis90 dayspost-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection
Number of participants with anastomotic bleeding90 dayspost-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026