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The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

NCT ID: NCT01861379

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colo-rectal Anastomosis Dehiscence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ghost Ileostomy

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

Group Type EXPERIMENTAL

Ghost Ileostomy

Intervention Type PROCEDURE

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.

No protective stoma

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

Group Type PLACEBO_COMPARATOR

Ghost Ileostomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Virtual Ileostomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Saverio Mari

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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DS-008

Identifier Type: -

Identifier Source: org_study_id