The Role of Ghost Ileostomy in Laparoscopic Rectal Resection (GILRR)

University of Roma La Sapienza

Status and phase: Completed; Phase 3

Conditions: Colo-rectal Anastomosis Dehiscence

Treatments: Procedure: Ghost Ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01861379

DS-008

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 2 patient groups, including a placebo group

Ghost Ileostomy

Experimental group

Description:

The patients were subjected to laparoscopic anterior rectal resection with performance of ghost ileostomy

Treatment:

Procedure: Ghost Ileostomy

No protective stoma

Placebo Comparator group

Description:

The patients were subjected to laparoscopic anterior rectal resection without simultaneous construction of any protective stoma.

Treatment:

Procedure: Ghost Ileostomy