The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

Phase 3

Completed

• Conditions: Colo-rectal Anastomosis Dehiscence

• Registration Number: NCT01861379
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of Clinical Evident Anastomotic Leak	15 days

Secondary Outcome Measures

Name	Time	Method
Postoperative complication	15 days
Ghost Ileostomy complications	15 days