The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

University of Roma La Sapienza107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

107

Conditions

Colo-rectal Anastomosis Dehiscence

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Presence of Clinical Evident Anastomotic Leak

Time frame: 15 days

Secondary Outcomes

Postoperative complication

Time frame: 15 days

Ghost Ileostomy complications

Time frame: 15 days

Data from ClinicalTrials.gov

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