The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

Study Overview
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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.

Official Title
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The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

Conditions
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Colo-rectal Anastomosis Dehiscence

Intervention / Treatment
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* Procedure: Ghost Ileostomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication |  | 15 days | 
| Ghost Ileostomy complications |  | 15 days |