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Single Port Colic Laparoscopic Surgery (TRUE)

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ClinicalTrials.gov Identifier: NCT01959087
Recruitment Status : Recruiting
First Posted : October 9, 2013
Last Update Posted : August 19, 2016
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

October 7, 2013
October 9, 2013
August 19, 2016
January 2014
February 2017   (Final data collection date for primary outcome measure)
Length of postoperative hospital stay [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01959087 on ClinicalTrials.gov Archive Site
  • Operative mortality [ Time Frame: 30 days ]
  • Post-operative morbidity [ Time Frame: Day 30 ]
  • Conversion rates [ Time Frame: Day 1 ]
  • Pathologic results [ Time Frame: Day 180 ]
  • Postoperative recovery [ Time Frame: 30 days ]
  • Postoperative pain [ Time Frame: 6 days ]
  • Aesthetic results [ Time Frame: 180 days ]
  • Costs [ Time Frame: Day 180 ]
  • Lenght of true hospitalization stay [ Time Frame: 30 days ]
  • Technical feasability [ Time Frame: Day 1 ]
  • Post-operative quality of life [ Time Frame: Day 180 ]
    SF-36 and GIQLI
Same as current
Not Provided
Not Provided
 
Single Port Colic Laparoscopic Surgery
Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
The aim of this study is to compare surgical results of colonic resection performed by single port and multiport laparoscopic approaches. Primary endpoint is the length of postoperative hospital stay. Secondary endpoints include postoperative mortality, postoperative morbidity, conversion rates, postoperative recovery, aesthetic results, postoperative pain, and costs
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Colonic Neoplasms
  • Crohn's Disease
  • Diverticulitis
  • Procedure: single port surgery
    Single port surgery can be converted in multiport surgery if necessary
  • Procedure: Multiport surgery
  • Experimental: 1: Single port surgery
    Surgery with single port
    Interventions:
    • Procedure: single port surgery
    • Procedure: Multiport surgery
  • Active Comparator: 2: Multiport surgery
    Surgery with multiport
    Intervention: Procedure: Multiport surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
Same as current
February 2017
February 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18
  • Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
  • Informed consent signed
  • Social Insurance

Exclusion Criteria:

  • Digestive stoma in place or planned during the intervention
  • Body mass index > 30 kg/m2
  • History of previous laparotomy, except Mc Burney, Pfannenstiel ou subcostal
  • Subtotal colectomy
  • Transverse colectomy
  • Proctectomy or total coloproctectomy
  • Synchronous metastasis
  • Preoperative suspicion of T4 colorectal cancer
  • Emergency procedure
  • Associated resection (except appendectomy or liver biopsy)
  • Pregnancy or current breast feeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Yves PANIS, MD, PhD 33 1.40.87.45.47 yves.panis@bjn.aphp.fr
Contact: Léon MAGGIORI, MD 33 1.40.87.45.47 leon.maggiori@bjn.aphp.fr
France
 
 
NCT01959087
P111112
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Principal Investigator: Yves PANIS, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP