Colorectal SurgeryGI_versus_LINCT04573075
Ghost Ileostomy (GI) Versus Loop Ileostomy (LI) After Colorectal Resections
A study testing Ghost ileostomy, loop ileostomy and no outlet in people with Colorectal Surgery, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Ghost ileostomy, loop ileostomy and no outlet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2019to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evangelisches Klinikum Koeln Weyertal
Cologne, North Rhine-Westphalia, 50931
About this study
Official title: Is a Ghost Ileostomy a Safe Alternative to a Protective Loop Ileostomy for Patients After Colorectal Resections ?
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.
Read the 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.
- Conditions
- Colorectal Surgery
- Being tested
- Ghost ileostomy, loop ileostomy, no outlet
- Keywords
- ghost ileostomy, loop ileostomy, colorectal resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghost ileostomyProcedure or surgery
Also called Ghost stoma
a loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy
loop ileostomyProcedure or surgery
a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis
no outletProcedure or surgery
no further intervention is used after colorectal resection and forming of a primary anastomosis
| Study group | Role | What they receive |
|---|---|---|
| no outlet | Other | no outlet is used after colorectal resection and forming of a primary anastomosis Receives: Procedure: no outlet |
| loop ileostomy | Active comparator | loop ileostomy is applied after colorectal resection and forming of a primary anastomosis Receives: Procedure: loop ileostomy |
| ghost ileostomy | Experimental | ghost ileostomy or ghost stoma (synonyms) is performed after colorectal resection and forming of a primary anastomosis Receives: Procedure: Ghost ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of one year
Secondary outcomes (1)
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.
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start31 Jan 2019
- Primary completion20 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Ghost ileostomy (short: ghost stoma) as an alternative to protective loop ileostomy or no outlet after colorectal resection
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne
- Responsible party
- Principal investigator, Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH
- Investigators
- Claudia L Rudroff, PhD MD, Principal investigator, EVK Koeln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573075
- Sponsor's protocol ID
- GI_observational_01_20
- Acronym
- GI_versus_LI
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25703524Ihnat 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.
PubMed 26902615Sacchi 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.
PubMed 18019692Hernandez 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.
PubMed 35478159
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Ghost Ileostomy a Safe Alternative to a Protective Loop Ileostomy for Patients After Colorectal Resections ?
- ClinicalTrials.gov ID
- NCT04573075
- Acronym / sponsor ID
- GI_versus_LI / GI_observational_01_20
- Conditions
- Colorectal Surgery
- Keywords
- ghost ileostomy, loop ileostomy, colorectal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Evangelisches Klinikum Köln Weyertal gGmbHUniversity, hospital or other
- Collaborators
- University of Cologne
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Ghost ileostomy (short: ghost stoma) as an alternative to protective loop ileostomy or no outlet after colorectal resection
| Arm | Type | Receives |
|---|---|---|
| no outlet | Other | Procedure: no outletno outlet is used after colorectal resection and forming of a primary anastomosis |
| loop ileostomy | Active comparator | Procedure: loop ileostomyloop ileostomy is applied after colorectal resection and forming of a primary anastomosis |
| ghost ileostomy | Experimental | Procedure: Ghost ileostomyghost ileostomy or ghost stoma (synonyms) is performed after colorectal resection and forming of a primary anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ghost ileostomyAlso: Ghost stomaa loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy | Procedure or surgery | ghost ileostomy |
| loop ileostomya protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis | Procedure or surgery | loop ileostomy |
| no outletno further intervention is used after colorectal resection and forming of a primary anastomosis | Procedure or surgery | no outlet |
Primary outcome
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.
1 secondary outcome
Morbidity and Mortality after ghost ileostomy compared to the other groups
Time frame: through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 25703524McDermott 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.
- Background: PubMed 26902615Ihnat 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.
- Background: PubMed 18019692Sacchi 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.
- Results publication: PubMed 35478159Hernandez 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.
- Standard operating procedure on the treatment of colorectal cancer in GermanyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia L Rudroff, PhD MD principal investigator
EVK Koeln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ghost ileostomy, loop ileostomy and no outlet in people with Colorectal Surgery, run by Evangelisches Klinikum Köln Weyertal gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of protective loop ileostomies avoided by the ghost stoma (time frame: through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573075, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.