The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
Phase 3
Completed
- Conditions
- Colo-rectal Anastomosis Dehiscence
- Interventions
- Procedure: Ghost Ileostomy
- 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
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
- Arm && Interventions
Group Intervention Description No protective stoma Ghost Ileostomy The patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma. Ghost Ileostomy Ghost Ileostomy The patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy
- 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