The Role of Ghost Ileostomy in Laparoscopic Rectal Resection (GILRR)

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.

Study Overview

• Status: Completed
• Conditions: Colo-rectal Anastomosis Dehiscence
• Intervention / Treatment: Procedure: Ghost Ileostomy

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Surgical Indication for Laparoscopic Anterior Rectal Resection
• Medium risk of anastomotic leakage

Exclusion Criteria:

• High risk of anastomotic leakage
• Lower risk of anastomotic leakage
• Advanced neoplasia (T4)
• Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
• Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ghost Ileostomy; The patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy	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.; Other Names: Virtual Ileostomy
Placebo Comparator: No protective stoma; The patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma.	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.; Other Names: Virtual Ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of Clinical Evident Anastomotic Leak	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative complication	15 days
Ghost Ileostomy complications	15 days

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 20, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DS-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No