Trial document




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  DRKS00013997

Trial Description

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Title

Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer – the GHOST-trial

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Trial Acronym

GHOST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

If a rectal cancer is sufficiently distant from the anal sphincter, it is usually possible to perform a continence-preserving surgery of the rectal cancer. An new connection between the two parts of the bowel after resection must be constructed deep in the pelvis. Due to the risk of leakage of the connection of the bowel ends (anastomotic leakage) a temporary stoma is usually created to drain the stool and thus protect the new connection. Since anastomotic leakages only occur in max. 25% of all cases, approximately 75% of the patients "unnecessarily" receive a stoma and have to undergo surgery a second time to close it and are at risk for complications related to the stoma.
The so-called ghost ileostomy is a promising precursor technique to allow a more selective decision to create a diverting stoma in rectal resection. Although a loop of the small intestine is prepared and tethered as usual with a rubber band, only the band is passed through the abdominal wall and the operation is finalized without stoma. In case of an anastomotic leakage, the small bowel can be exteriorized in a secondary small operation along the rubber band to create a stoma and minimize the consequences of anastomotic leakage. The aim of this study is to investigate the safety and feasibility of ghost ileostomy compared to conventional ileostomy after continent-preserving recum tumor surgery.

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Brief Summary in Scientific Language

Colorectal cancer is currently the second most common malignancy in Europe and the second most common cause of cancer death, with one third of the tumors located in the rectum. Rectal carcinomas can usually be treated by a sphincter-preserving surgery in terms of a low anterior rectal resection (LAR) with total mesorectal excision (TME). However, since the risk of anastomotic leakage is between 3 and 23%, in most patients a protective ileostomy is created to minimze the consequences of anastomotic leakage. Stoma-related complications such as peristomal abscess, parastomal hernias or high fluid loss due to high stoma output and possible complications after stoma reversal should be considered in patients undergoing LAR/TME with protective ileostomy. Assuming that 75% of patients "unnecessarily" receive a protective ileostomy with the above-mentioned risks, the concept of ghost ileostomy provides an approach for a more selective use of ileostomies.
Based on the promising results of previous studies, the randomized controlled GHOST trial will compare ghost ileostomy with the current clinical practice of routine protective ileostomy after LAR/TME .
The primary goal of the GHOST study is to compare the safety and feasibility of GHOST ileostomy with the current standard of conventional loop ileostomy in patients receiving elective LAR/TME for rectal cancer. The Comprehensive Complication Index not only records direct surgical complications but also stoma-related morbidity within three months of LAR/TME.
In addition, the data obtained from this study will form the basis for a later confirmatory study if the ghost ileostomy proves to be a safe alternative to conventional ileostomy.

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Organizational Data

  •   DRKS00013997
  •   2018/04/09
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  •   yes
  •   Approved
  •   S-694/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1208-9742 
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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Ghost ileostomy fashioned at the end of the operation
  •   Conventional protective loop ileostomy fashioned at the end of the operation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

To evaluate the safety and feasibility of a ghost ileostomy compared to conventional loop ileostomy in patients undergoing elective low anterior resection for rectal cancer

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Secondary Outcome

1. Comprehensive Complication Index during 30 days and 6 months after index operation
2. Anastomotic leakage (according to the ISREC definition)
3. Frequency of transformation of ghost ileostomy into protective loop ileostomy
4. 30-day mortality
5. reoperations
6. rate of terminal ostomy
7. Intra-abdominal abscess
8. Need for interventional drainage
9. Completion of intended chemotherapy
10. QoL (EORTC QLQ-C30, CR29)
11. Stoma related complications
12. Survival
13. Complications after ileostomy closure
14. Mean length of bearing the stoma (in days)
15. Postoperative anorectal function 6 months after initial surgery (Wexner score)
16. Patients with stoma (terminal / loop) at 6 months after initial surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients undergoing elective low anterior resection for rectal cancer
- Ability of subject to understand character and individual consequences of the clinical trial
- ≥ 18 years of age
- Written informed consent

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Exclusion Criteria

Preoperative exclusion criteria:
- BMI >30 kg/m²
- ASA >3
- Chronic renal failure (necessitating dialysis or GFR <30 ml/min)
- Immunosuppression (cortisone ≥ 40 mg/d or equivalent; azathioprine, etc.)
- Significant cardiac disease
- Current therapeutic anticoagulation
- Liver cirrhosis (of any Child-Pugh grade)
- Ultralow rectal cancer (<4 cm ab ano, or necessitating intersphincteric resection or transanal colo-anal anastomosis)
- Participation in another intervention trial with interference of intervention and outcome of this study

Intraoperative exclusion criteria:
- Incomplete stapling rings
- Positive intraoperative air (bubble) test
- Intraoperative findings that make a loop ileostomy inevitable in the individual surgeon’s opinion (e.g. intraoperative diagnosis of liver cirrhosis, acute or chronic Ileus, intraoperative lesion of the rectum, urinary bladder, vagina, etc.)
- Multivisceral resection

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Addresses

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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • INF 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Markus K.  Diener 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Dr. med.  Felix  Hüttner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Heidelberger Stiftung Chirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.