Single Port Colic Laparoscopic Surgery (TRUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01959087
Recruitment Status : Recruiting
First Posted : October 9, 2013
Last Update Posted : August 19, 2016
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 Phase 3

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

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

Secondary Outcome Measures :
  1. Operative mortality [ Time Frame: 30 days ]
  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

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 identifier (NCT number): NCT01959087

Contact: Yves PANIS, MD, PhD 33
Contact: Léon MAGGIORI, MD 33

Service de Chirurgie Colorectale Recruiting
Clichy, Ile de France, France, 92110
Contact: Yves PANIS, MD, PhD    33   
Contact: Leon MAGGIORI, MD    33   
Principal Investigator: Yves PANIS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Principal Investigator: Yves PANIS, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01959087     History of Changes
Other Study ID Numbers: P111112
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Single port surgery
Colonic surgery
Postoperative morbidity
Postoperative outcomes

Additional relevant MeSH terms:
Crohn Disease
Colonic Neoplasms
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Intraabdominal Infections
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases