Trial document




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  DRKS00000040

Trial Description

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Title

HAnd-suture versus STApling for Closure of Loop Ileostomy

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Trial Acronym

HASTA Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with history of low anterior resection (LAR) due to rectal cancer and placement of protective loop ileostomy undergoing closure of loop ileostomy.
To investigate differences in frequency of bowel obstruction after stapling versus hand-suture loop ileostomy closure.

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Brief Summary in Scientific Language

Colorectal cancer is the second most common tumor in developed countries, with a lifetime incidence of 5%(1;2). Approximately 30% of these tumors are located in the rectum. Surgery forms the cornerstone in the treatment of rectal cancer, with the low anterior resection (LAR) being the standard procedure(3). A transient protective loop ileostomy should be created in patients undergoing LAR in order to protect the deep rectal anastomosis until definite healing is achieved(4-6). After a period of three months the ileostomy is subsequently closed and intestinal continuity is re-established. Due to the high incidence of rectal cancer, closure of loop ileostomy is a frequently performed procedure in surgical routine. While there are two techniques available for closure of loop ileostomy (the hand-sutured and the stapled anastomosis), valid data are missing which one of these techniques should preferably be used in daily practice.

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Organizational Data

  •   DRKS00000040
  •   2008/10/27
  •   [---]*
  •   yes
  •   Approved
  •   S-278/2008, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Closure of Loop ileostomy after Low anterior resection due to colon carcinoma
  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   The stapler is brought into the two opened antimesenteric apexes of the intestinal shanks to facilitate side-to-side (functional end-to-end) anastomosis. The apex of the loop and the spout is cross-stapled with a refill of the GIA-stapler followed by overstitching the cross-stapled line with a Polydioxanon equivalent suture (USP 5-0/Ethicon, Norderstedt). The intestine is then put back into the peritoneal cavity. The abdominal wall is closed with interrupted sutures using Polyglactin equivalent sutures (USP 2). The subcutaneous tissue is not sutured and no subcutaneous drainage is used. The skin can be closed by either interrupted monofilament sutures or clips.
  •   After thorough mobilisation the loop ileostomy is resected using two bowel clamps. An end-to-end anastomosis is performed as follows: a two-layer continuous suture using four Polydioxanon equivalent sutures (USP 5-0). The inner layer consists of a transmural suture, the outer layer of a sero-muscular suture. Alternatively interrupted sutures could be performed depending on local standards. The abdominal wall and the skin are closed in the same way as for stapled closure.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

Frequency of bowel obstruction within 30 days after ileostomy closure

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Secondary Outcome

Time needed to perform the procedure/Wound infection/Frequency of re-operation due to anastomotic leakage of the ileostomy closure/Time to first tolerance to solid food and first bowel movement, whichever of these occurred last/Length of postoperative hospital stay/30 day and one year mortality after ileostomy closure/Frequency of re-operation and re-hospitalization within one year due to bowel obstruction/Costs of surgical procedure/Quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University 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 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2009/02/13
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Preoperative
Patients, 18 years or older, scheduled for elective ileostomy closure after Low Anterior Resection (LAR)/Given Inormed Consent

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Exclusion Criteria

Preoperative:
Pathologic findings in routine preoperative diagnostic tests (e.g anastomotic leakage), which do not allow a safe ileostomy closure./Participation in another intervention trial with interference of intervention and outcome of this study/Expected lack of compliance

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Addresses

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    • Universitätsklinikum Heidelberg - Verwaltung
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Chirurgische Klinik der Universität Heidelberg
    • Ms.  Inga  Rossion 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • SDGC Heidelberg Chirurgische Klinik der Universität Heidelberg
    • Ms.  Inga  Rossion 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg - Verwaltung
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Johnson & Johnson MEDICAL
    • Hummelsbütteler Steindamm 71
    • 22851  Norderstedt
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   2011/10/27
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Trial Publications, Results and other Documents

  •   Veröffentlichung Studienprotokoll
  •   Löffler T, Rossion I, Bruckner T, Diener MK, Weitz J et al; HASTA Trial Group: HAnd Suture versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97
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* This entry means the parameter is not applicable or has not been set.