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

Colorectal Surgery Clinical Trial

— GI_versus_LI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573075
• Other study ID #: GI_observational_01_20
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: March 20, 2022

Study information

• Verified date: January 2024
• Source: Evangelisches Klinikum Köln Weyertal gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: March 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

Exclusion Criteria:

• no informed consent

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Procedure:
• Ghost ileostomy
a loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy
• loop ileostomy
a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis
• no outlet
no further intervention is used after colorectal resection and forming of a primary anastomosis

Locations

Country	Name	City	State
Germany	Evangelisches Klinikum Koeln Weyertal	Cologne	Northrhine Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Evangelisches Klinikum Köln Weyertal gGmbH	University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Baloyiannis I, Perivoliotis K, Diamantis A, Tzovaras G. Virtual ileostomy in elective colorectal surgery: a systematic review of the literature. Tech Coloproctol. 2020 Jan;24(1):23-31. doi: 10.1007/s10151-019-02127-2. Epub 2019 Dec 9. — View Citation

Hajili K, Vega Hernandez A, Otten J, Richards D, Rudroff C. Risk factors for early and late morbidity in patients with cardiovascular disease undergoing inguinal hernia repair with a tailored approach: a single-center cohort study. BMC Surg. 2023 Jan 14;2 — View Citation

Huser N, Michalski CW, Erkan M, Schuster T, Rosenberg R, Kleeff J, Friess H. Systematic review and meta-analysis of the role of defunctioning stoma in low rectal cancer surgery. Ann Surg. 2008 Jul;248(1):52-60. doi: 10.1097/SLA.0b013e318176bf65. — View Citation

Ihnat P, Gunkova P, Peteja M, Vavra P, Pelikan A, Zonca P. Diverting ileostomy in laparoscopic rectal cancer surgery: high price of protection. Surg Endosc. 2016 Nov;30(11):4809-4816. doi: 10.1007/s00464-016-4811-3. Epub 2016 Feb 22. — View Citation

Mari FS, Di Cesare T, Novi L, Gasparrini M, Berardi G, Laracca GG, Liverani A, Brescia A. Does ghost ileostomy have a role in the laparoscopic rectal surgery era? A randomized controlled trial. Surg Endosc. 2015 Sep;29(9):2590-7. doi: 10.1007/s00464-014-3974-z. Epub 2014 Dec 5. — View Citation

McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19. — View Citation

Sacchi M, Legge PD, Picozzi P, Papa F, Giovanni CL, Greco L. Virtual ileostomy following TME and primary sphincter-saving reconstruction for rectal cancer. Hepatogastroenterology. 2007 Sep;54(78):1676-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health care expenses	the 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	through study completion, an average of one year
Other	participants' satisfaction with the experimental intervention	measurement of participants satisfaction on a scale between 1 (not satisfied at all) to 4 (very satisfied)	through study completion, an average of one year
Other	operating time needed in cases of a ghost ileostomy	operating time in minutes of the group with a GI compared to the group with an LI and the group with no outlet	through study completion, an average of one year
Primary	number of protective loop ileostomies avoided by the ghost stoma	The number of ghost ileostomies that did not need to be transformed to a loop ileostomy is counted.	through study completion, an average of one year
Secondary	Morbidity and Mortality after ghost ileostomy compared to the other groups	Surgical 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.	through study completion, an average of one year

External Links

•   Standard operating procedure on the treatment of colorectal cancer in Germany