Colo-rectal Anastomosis Dehiscence
Conditions
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.
Interventions
PROCEDUREGhost 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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of Clinical Evident Anastomotic Leak | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complication | 15 days |
| Ghost Ileostomy complications | 15 days |
Outcome results
None listed