The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

NCT01861379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2016-11-22

No results posted yet for this study

Summary

To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.

Conditions

  • Colo-rectal Anastomosis Dehiscence

Interventions

PROCEDURE

Ghost Ileostomy

At the end of Laparoscopic Anterior Rectal Resection, once the colorectal anastomosis was performed, the terminal ileum was identified and a window in the mesentery was created to pass a rubber tube (we usually use an urinary catheter) around the intestinal loop. The tube was subsequently exteriorized trough the trocar incision in the right flank.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861379 on ClinicalTrials.gov