NCT01861379

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

6 years

First QC Date

May 21, 2013

Last Update Submit

November 20, 2016

Conditions

Colo-rectal Anastomosis Dehiscence

Outcome Measures

Primary Outcomes (1)

  • Presence of Clinical Evident Anastomotic Leak

    15 days

Secondary Outcomes (2)

  • Postoperative complication

    15 days

  • Ghost Ileostomy complications

    15 days

Study Arms (2)

Ghost Ileostomy

EXPERIMENTAL

The patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy

Procedure: Ghost Ileostomy

No protective stoma

PLACEBO COMPARATOR

The patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma.

Procedure: Ghost Ileostomy

Interventions

Ghost IleostomyPROCEDURE

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.

Also known as: Virtual Ileostomy
Ghost IleostomyNo protective stoma

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 23, 2013

Study Start

January 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 22, 2016

Record last verified: 2016-11