Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections
NCT ID: NCT04573075
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
257 participants
INTERVENTIONAL
2019-01-31
2022-03-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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no outlet
no outlet is used 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
loop ileostomy
loop ileostomy is applied after colorectal resection and forming of a primary anastomosis
loop ileostomy
a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis
ghost ileostomy
ghost ileostomy or ghost stoma (synonyms) is performed after colorectal resection and forming of a primary anastomosis
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Evangelisches Klinikum Köln Weyertal gGmbH
OTHER
Responsible Party
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Claudia Rudroff
Head of the Department for Visceral Surgery and Surgery of the lower Gastrointestinal Tract
Principal Investigators
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Claudia L Rudroff, PhD MD
Role: PRINCIPAL_INVESTIGATOR
EVK Koeln
Locations
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Evangelisches Klinikum Koeln Weyertal
Cologne, North Rhine-Westphalia, Germany
Countries
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References
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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.
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.
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.
Hernandez AV, Otten J, Christ H, Ulrici C, Piriyev E, Ludwig S, Rudroff C. Ghost Ileostomy: Safe and Cost-effective Alternative to Ileostomy After Rectal Resection for Deep Infiltrating Endometriosis. In Vivo. 2022 May-Jun;36(3):1290-1296. doi: 10.21873/invivo.12829.
Related Links
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Standard operating procedure on the treatment of colorectal cancer in Germany
Other Identifiers
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GI_observational_01_20
Identifier Type: -
Identifier Source: org_study_id
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