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Single Port Colic Laparoscopic Surgery (TRUE)

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ClinicalTrials.gov Identifier: NCT01959087
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Crohn's Disease Diverticulitis Procedure: single port surgery Procedure: Multiport surgery Not Applicable

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
Actual Study Start Date : January 27, 2014
Actual Primary Completion Date : February 24, 2017
Actual Study Completion Date : March 24, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: Single port surgery
Surgery with single port
Procedure: single port surgery
Single port surgery can be converted in multiport surgery if necessary

Procedure: Multiport surgery
Active Comparator: 2: Multiport surgery
Surgery with multiport
Procedure: Multiport surgery



Primary Outcome Measures :
  1. Length of postoperative hospital stay [ Time Frame: 30 days ]
    Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge


Secondary Outcome Measures :
  1. Operative mortality [ Time Frame: 30 days ]
    Operative mortality rate; Overall morbidity rate at 30 days postoperatively including infectious and noninfectious morbidity according to the DINDO classification; Rates of incisional herniation, occlusion, rehospitalization related to the surgical procedure and reintervention until J180; Actual hospital stay;

  2. Post-operative morbidity [ Time Frame: Day 30 ]
  3. Conversion rates [ Time Frame: Day 1 ]
  4. Pathologic results [ Time Frame: Day 180 ]
  5. Postoperative recovery [ Time Frame: 30 days ]
  6. Postoperative pain [ Time Frame: 6 days ]
  7. Aesthetic results [ Time Frame: 180 days ]
  8. Costs [ Time Frame: Day 180 ]
  9. Lenght of true hospitalization stay [ Time Frame: 30 days ]
  10. Technical feasability [ Time Frame: Day 1 ]
  11. Post-operative quality of life [ Time Frame: Day 180 ]
    SF-36 and GIQLI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959087


Locations
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France
Service de Chirurgie Colorectale
Clichy, Ile De France, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Investigators
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Principal Investigator: Yves PANIS, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01959087    
Other Study ID Numbers: P111112
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Single port surgery
Colonic surgery
Postoperative morbidity
Postoperative outcomes
Additional relevant MeSH terms:
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Diverticulitis
Colonic Neoplasms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases