Trial record 17 of 21 for:    Open Studies | "Diverticulitis"

Single Port Colic Laparoscopic Surgery (TRUE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01959087
First received: October 7, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Colonic Neoplasms
Crohn's Disease
Diverticulitis
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: October 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (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
NA
Active Comparator: 2: Multiport surgery
Surgery with multiport
Procedure: Multiport surgery
NA

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT01959087

Contacts
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

Locations
France
Service de Chirurgie Colorectale Not yet recruiting
Clichy, Ile de France, France, 92110
Contact: Yves PANIS, MD, PhD    33 1.40.87.45.47    yves.panis@bjn.aphp.fr   
Contact: Leon MAGGIORI, MD    33 1.40.87.45.47    leon.maggiori@bjn.aphp.fr   
Principal Investigator: Yves PANIS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de l'Avenir
Investigators
Principal Investigator: Yves PANIS, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01959087     History of Changes
Other Study ID Numbers: P111112
Study First Received: October 7, 2013
Last Updated: October 7, 2013
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:
Diverticulitis
Neoplasms
Colonic Neoplasms
Crohn Disease
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on July 22, 2014