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

• ClinicalTrials.gov Identifier: NCT04573075
• Recruitment Status: Recruiting
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH
• Collaborator: University of Cologne
• Information provided by (Responsible Party): Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Surgery	Procedure: Ghost ileostomy; Procedure: loop ileostomy; Procedure: no outlet	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Ghost ileostomy (short: ghost stoma) as an alternative to protective loop ileostomy or no outlet after colorectal resection
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Is a Ghost Ileostomy a Safe Alternative to a Protective Loop Ileostomy for Patients After Colorectal Resections ?
• Actual Study Start Date: January 31, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
no outlet; no outlet is used after colorectal resection and forming of a primary anastomosis	Procedure: no outlet; no further intervention is used after colorectal resection and forming of a primary anastomosis
Active Comparator: loop ileostomy; loop ileostomy is applied after colorectal resection and forming of a primary anastomosis	Procedure: loop ileostomy; a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis
Experimental: ghost ileostomy; ghost ileostomy or ghost stoma (synonyms) is performed after colorectal resection and forming of a primary anastomosis	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; Other Name: Ghost stoma

Outcome Measures

Primary Outcome Measures :

1. number of protective loop ileostomies avoided by the ghost stoma [ Time Frame: through study completion, an average of one year ]
   The number of ghost ileostomies that did not need to be transformed to a loop ileostomy is counted.

Secondary Outcome Measures :

1. Morbidity and Mortality after ghost ileostomy compared to the other groups [ Time Frame: through study completion, an average of one year ]
   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.

Other Outcome Measures:

1. health care expenses [ Time Frame: through study completion, an average of one year ]
   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
2. participants' satisfaction with the experimental intervention [ Time Frame: through study completion, an average of one year ]
   measurement of participants satisfaction on a scale between 1 (not satisfied at all) to 4 (very satisfied)
3. operating time needed in cases of a ghost ileostomy [ Time Frame: through study completion, an average of one year ]
   operating time in minutes of the group with a GI compared to the group with an LI and the group with no outlet

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: participants eligibility is based in self-representation of gender identity
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• informed consent

Exclusion Criteria:

• no informed consent

Contacts and Locations

Contacts

Contact: Claudia L Rudroff, PhD MD; -49-221-479 ext 32524; claudia.rudroff@evk-koeln.de

Locations

Germany

Evangelisches Klinikum Koeln Weyertal; Recruiting

Cologne, Northrhine Westphalia, Germany, 50931

Contact: Claudia L Rudroff, PhD MD +49-221-479 ext 32524 claudia.rudroff@evk-koeln.de

Contact: Christoph Ulrici +49-221-479 ext 32311 Christoph.ulrici@evk-koeln.de

Sub-Investigator: Alberto Vega Hernandez

Sub-Investigator: Costanza Chiapponi

Sponsors and Collaborators

Evangelisches Klinikum Köln Weyertal gGmbH

University of Cologne

Investigators

• Principal Investigator: Claudia L Rudroff, PhD MD; EVK Koeln

More Information

Additional Information:

Standard operating procedure on the treatment of colorectal cancer in Germany 

Publications:

Hüser 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. Review.

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. Review.

Ihnát P, Guňková P, Peteja M, Vávra P, Pelikán A, Zonča P. Diverting ileostomy in laparoscopic rectal cancer surgery: high price of protection. Surg Endosc. 2016 Nov;30(11):4809-4816. Epub 2016 Feb 22.

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.

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.

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.

• Responsible Party: Claudia Rudroff, Head of the Department for Visceral Surgery and Surgery of the lower Gastrointestinal Tract, Evangelisches Klinikum Köln Weyertal gGmbH
• ClinicalTrials.gov Identifier: NCT04573075
• Other Study ID Numbers: GI_observational_01_20
• First Posted: October 5, 2020
• Last Update Posted: October 5, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH:

ghost ileostomy; loop ileostomy; colorectal resection