Trial document




drksid header

  DRKS00005123

Trial Description

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Title

Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a randomised, controlled, multicenter trial.

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Trial Acronym

The C-Seal Study

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URL of the Trial

http://www.csealtrial.com/

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Brief Summary in Lay Language

The main objective of this trial is to find out wether the use of a C-Seal leads to fewer suture leakages after surgery of the large intestine or rectum.
Due to a medical problem with an intestine, part of the large intestine or rectum will need to be removed. Both ends will be sutured to create a functioning passage. This new connection is called an intestinal suture. One possible complication is leakage of this intestinal suture. The contents of the intestine will leak into the abdominal cavity. This can lead to peritonitis. The chance of leakage in intestinal sutures located close to the anus is approximately 10 %.
In order to reduce the likelihood of leakage of an intestinal suture, a biodegradable drain (a kind of thin tube) with a thin wall has been developed - The C-Seal. This drain is placed over the intestinal suture in the intestine during surgery. The drain will decompose automatically, so it does not need to be removed.
Before you undergo surgery, your doctor will discuss the procedure with you. The surgical procedure will be done in the usual way. Lots will be drawn to determine whether or not you will receive the C-Seal.
In either case the connection between the large intestine and the rectum will be made using a surgical stapler. In patients who receive a C-Seal, the intestinal connection will be made and then C-Seal will be joined to the connection using those staples. After surgery, a small portion of the drain will protrude from your anus. As it is made of a soft material, it will cause very little discomfort to you.
Before you leave the hospital, the drain will be shortened, so that it will not cause any discomfort at all to you once you are back home. The drain will disintegrate after 2 to 4 weeks. When it does, you may find some pieces of it in your faces.
The efficacy of the C-Seal will be evaluated after your hospital discharge as well as after 30 days and after 1 year after operation by phone call or routine hospital visit.
All patients aged 18 years of above who must undergo a non-urgent surgical procedure involving an intestinal suture due to an intestinal complaint are asked to participate in this trial.

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Brief Summary in Scientific Language

Anastomotic leakage (AL) is a major complication in colorectal surgery. The incidence of AL in colorectal anastomoses is about 10 %. In order to reduce the incidence of anastomotic leakage, the C-Seal is developed.
This intraluminal biodegradable drain is developed to prevent extravasation of intracolonic content to the peritoneal cavity in case of an anastomotic dehiscence.
The primary endpoint/outcome is the incidence of anastomotic leakage leading to invasive treatment within 30
days after the primary operation.
The following hypotheses will be examined:
H(0): There is no difference in percentage of Leakage between the C-seal group and the control group (or a higher
percentage of Leakage in the C-seal group).
H(1): The percentage of Leakage in the C-seal group is lower than in the control group.
Your doctor will discuss the operation/procedure in detail with you. The surgical procedure will be done in the usual way. Lots will be drawn to determine whether or not you will receive the C-Seal.
In either case the connection between the large intestine and the rectum will be made using a surgical stapler. In patients who receive a C-Seal, the intestinal connection will be made and then C-Seal will be joined to the connection using those staples. After surgery, a small portion of the drain will protrude from your anus. As it is made of a soft material, it will cause very little discomfort to you.
Before you leave the hospital, the drain will be shortened, so that it will not cause any discomfort at all to you once you are back home. The drain will disintegrate after 2 to 4 weeks. When it does, you may find some pieces of it in your faces.
The efficacy of the C-Seal will be evaluated after your hospital discharge as well as after 30 days and after 1 year after operation by phone call or routine hospital visit.
All patients aged 18 years of above who must undergo a non-urgent surgical procedure involving an intestinal suture due to an intestinal complaint are asked to participate in this trial.

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Organizational Data

  •   DRKS00005123
  •   2013/07/02
  •   2011/09/26
  •   yes
  •   Approved
  •   2012-414M-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   NTR3080  (Netherlands Trial Register)
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Health Condition or Problem studied

  •   Anastomotic Leakage after colorectal surgery
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Interventions/Observational Groups

  •   The Sponsor wants to enroll overall 616 patients in this study. Each group (Intervention group vs. Control group) should include 313 patients.
    Procedure: After the physician has decided to make an anastomosis during the surgery the patient will be randomized either to the intervention group (with C-Seal application) or to the control group (without C-Seal application).
    If the patient will be assigned to the intervention group the C-Seal will be used. It will be stapled to the anastomosis during the operation.
    After surgery and after the discharge of the hospital two follow-up visits will be conducted either by phone call or within a routine visit at the hospital.

  •   The operation within the control group will be conducted according the local standard but without the C-seal.
    In general, the overall study will be conducted without any additional visits or burden for the patients. All steps and procedures will be done due to the local requirements.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the incidence of anastomotic leakage leading to invasive treatment within 30 days after the primary operation.

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Secondary Outcome

Secondary Outcomes:
- Number of dismantled anastomoses
- Grade A, B or C Anastomotic Leakage
- Interval between the primary operation and the diagnosis of Anastomotic Leakage
- Pain Score at day 3 postoperatively on a visual analogue scale
- Number of ostomies created
- Late anastomotic leakage (diagnosed 30 days after the primary operation)
- Number of ostomies present after one year
- Total duration of hospital stay including readmissions for (serious) adverse events and/or stoma closure
- Interval between the primary operation and the excretion of the C-Seal through the anus
- Other complications

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Countries of Recruitment

  •   Germany
  •   Netherlands
  •   Austria
  •   Spain
  •   Italy
  •   France
  •   United Kingdom
  •   Portugal
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/10/15
  •   616
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- The patient will receive a colorectal anastomosis by means of stapling
- Elective surgery
- Age: 18 or older
- American Society of Anesthesiologist (ASA) classification 1,2 or 3
- The patient did receive preoperative oral mechanical bowel preparation

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Exclusion Criteria

- There are clinical signs of peritonitis
- The patient underwent major surgical or interventional procedures in the last 30 days prior to this study or surgical or interventional procedures are planned within 30 days of entry in this study
- There are psychological, familial, sociological conditions which could hampering compliance with the study protocol or follow-up schedule
- Patient is randomized in this trial before

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University Medical Center Groningen Department of Abdominal Surgery
    • Mr.  Klaas  Havenga 
    • P.O. Box 30.001
    • 9700 RB  Groningen
    • Netherlands
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • University Medical Center Groningen Department of Abdominal Surgery
    • Mr.  Klaas  Havenga 
    • P.O. Box 30.001
    • 9700 RB  Groningen
    • Netherlands
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    • University Medical Center Groningen Department of Abdominal Surgery
    • Ms.  Ilsalien  Bakker 
    • P.O. Box 30.001
    • 9700 RB  Groningen
    • Netherlands
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    •   +316-31623612; +3150-3611505
    •   +3150-3614873
    •   i.s.bakker at umcg.nl
    •   [---]*
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Sources of Monetary or Material Support

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    • University Medical Center Groningen Department of Abdominal Surgery
    • Ms.  Ilsalien  Bakker 
    • P.O. Box 30.001
    • 9700 RB  Groningen
    • Netherlands
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    •   +316-31623612; +3150-3611505
    •   +3150-3614873
    •   i.s.bakker at umcg.nl
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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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.