Single Port Colic Laparoscopic Surgery (TRUE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: October 7, 2013
Last updated: October 6, 2015
Last verified: October 2015
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.

Condition Intervention Phase
Colonic Neoplasms
Crohn's Disease
Procedure: single port surgery
Procedure: Multiport surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Length of postoperative hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Post-operative morbidity [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
  • Conversion rates [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Pathologic results [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Postoperative recovery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Aesthetic results [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Costs [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Lenght of true hospitalization stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Technical feasability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Post-operative quality of life [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    SF-36 and GIQLI

Estimated Enrollment: 128
Study Start Date: January 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01959087     History of Changes
Other Study ID Numbers: P111112 
Study First Received: October 7, 2013
Last Updated: October 6, 2015
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Colonic Neoplasms
Crohn Disease
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Intraabdominal Infections
Neoplasms by Site processed this record on May 22, 2016