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Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections

Is a Ghost Ileostomy a Safe Alternative to a Protective Loop Ileostomy for Patients After Colorectal Resections ?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04573075
Acronym
GI_versus_LI
Enrollment
257
Registered
2020-10-05
Start date
2019-01-31
Completion date
2022-03-20
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

Keywords

ghost ileostomy, loop ileostomy, colorectal resection

Brief summary

A Ghost Ileostomy (GI) as an alternative to a diverting protective Loop Ileostomy (LI) after colorectal resection is offered the patients at risk preoperatively. A GI is only applied in cases, who would receive a LI otherwise.

Detailed description

A protective loop ileostomy (LI) is applied to protect a critical anastomosis after left sided colorectal resections. It is routinely indicated after low anterior rectal resection because this location carries a high risk for anastomotic insufficiency due to poor blood supply and tension of the bowel itself. A LI is also used to protect a primary anastomosis after other colorectal resections, if the surgeon in charge deems it necessary. However, the LI does not reduce the rate of insufficiencies (between 8-18%), but decreases the rate and severity of the associated complications and its mortality. Furthermore, the LI is associated with complications of its own. Stoma malfunction due to torsion may cause a bowel obstruction, local complications may lead to an abscess or wound dehiscence, and in the long term follow-up surgical interventions due to hernias at the stoma site or adhesions with a consecutive ileus may become necessary. Additionally, many patients are traumatized by the thought of a stoma. Thus, the routine application of a LI is currently critically discussed and its need re-evaluated. A Ghost ileostomy (GI) is an alternative. Instead of a real diverting stoma the suitable small bowel loop is marked with a silicon strap, which is externalized through the abdominal wall and fixed with sutures. No real stoma outlet needs to be formed. In case of an anastomotic leakage (AL) the GI is easily converted to a LI by extracting the marked bowel loop through the abdominal wall. Besides increasing patients' comfort, ileostomy-related morbidity, hospital re-admissions for the closure of the ileostomy, and health care expenses related to the stoma supply and complications can be avoided. In a recent systematic review of the existing literature Baloyiannis et al. identified 11 studies with altogether 554 patients. They found a total complication rate of 13.9%, with 2,1% GI-specific adverse events. Although it is a safe and comfortable option for low- and medium-risk patients it is still not established routinely. Aim of the study: The study wants to examen whether the routine use of a GI after colorectal resection with primary anastomosis can reduce the number of LI needed. This should avoid the stoma associated complications and the re-hospitalization for the stoma closure. A further endpoint is the routine use of GI as an alternative has to ensure patients safety. No further risk should result from this new intervention. Study design: Prospective clinical observational study Method: All patients after a colorectal resection with a primary anastomosis are offered the option of a GI as an alternative to a LI preoperatively. They have to consent in a stoma, if the surgeon in charge deems this necessary during the procedure. Written informed consent is obtained prior to surgery. At the end of the colorectal resection the surgeon in charge decided whether to shape a GI, a LI or no outlet. General criteria for a stoma are a redo anastomosis, an ultralow rectal resection, peritonitis at the site of the anastomosis, or an extended endometriosis resection in the pelvis. In case of emergency surgery a Hartman procedure may become necessary due to the critical condition of the patient. A GI is only applied in cases, who would have received a LI otherwise. Technically, a silicon loop (Roeser Loops super maxi, Ref No 10.11522; Roeser Medical GmbH, Bochum, Germany; conformity european (CE) 0481) marks a suitable terminal ileum loop and is externalized through the 5 m trocar site regularly placed in the right upper quadrant of the abdomen or a similar mini-incision in cases of open surgery. The loop is fixed with two penetrating, non-absorbable sutures and closed with a wound dressing. Postoperatively patients are observed on the intensive care unit (ICU) for 12-48 hours. Further action - ultrasound, CT scan, and/or colonoscopy - is taken in cases of fever, laboratory signs of inflammation (leucocyte count \>15x1000ul, procalcitonin \>1 ng/ml, or C-reactive protein more than three times the initial value). Pelvic fluid collection, bowel malfunction, or signs of anastomotic leakage will lead to a re-operation converting the GI to a LI and an abdominal lavage with drainage, if necessary. In all other cases of GI the silicon strap will be removed after the initiation of bowel function. All patients included will be asked about their well being and medical treatments related to their colorectal resection after their dismission in a follow-up phone call 6 months after surgery. The study ends with this last survey.

Interventions

a loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy

a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis

PROCEDUREno outlet

no further intervention is used after colorectal resection and forming of a primary anastomosis

Sponsors

University of Cologne
CollaboratorOTHER
Evangelisches Klinikum Köln Weyertal gGmbH
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Ghost ileostomy (short: ghost stoma) as an alternative to protective loop ileostomy or no outlet after colorectal resection

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* informed consent

Exclusion criteria

* no informed consent

Design outcomes

Primary

MeasureTime frameDescription
number of protective loop ileostomies avoided by the ghost stomathrough study completion, an average of one yearThe number of ghost ileostomies that did not need to be transformed to a loop ileostomy is counted.

Secondary

MeasureTime frameDescription
Morbidity and Mortality after ghost ileostomy compared to the other groupsthrough study completion, an average of one yearSurgical outcome measured concerning the postoperative morbidity and mortality according to the Clavien Dindo classification (CDC). CDC distinguishes: no complication = 0; mild complication without further intervention needed = 1; mild complication with medication like antibiotics needed=2; complication with further intervention needed =3a, complication with further intervention under general anesthesia needed =3b; septic complication =4; death =5.

Other

MeasureTime frameDescription
health care expensesthrough study completion, an average of one yearthe amount of health care expenses spared by applying a ghost stoma compared to the general costs of a stoma closure, if applicable; results are expressed in €s per case
participants' satisfaction with the experimental interventionthrough study completion, an average of one yearmeasurement of participants satisfaction on a scale between 1 (not satisfied at all) to 4 (very satisfied)
operating time needed in cases of a ghost ileostomythrough study completion, an average of one yearoperating time in minutes of the group with a GI compared to the group with an LI and the group with no outlet

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026