TRUE: Single Port Colic Laparoscopic Surgery

Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed ID
Fondation de l'Avenir (Other)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: single port surgery
  • 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

Study Design

Study Type:
Actual Enrollment :
128 participants
Intervention Model:
Parallel Assignment
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
Actual Study Start Date :
Jan 27, 2014
Actual Primary Completion Date :
Feb 24, 2017
Actual Study Completion Date :
Mar 24, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Length of postoperative hospital stay [30 days]

    Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge

Secondary Outcome Measures

  1. Operative mortality [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 [Day 30]

  3. Conversion rates [Day 1]

  4. Pathologic results [Day 180]

  5. Postoperative recovery [30 days]

  6. Postoperative pain [6 days]

  7. Aesthetic results [180 days]

  8. Costs [Day 180]

  9. Lenght of true hospitalization stay [30 days]

  10. Technical feasability [Day 1]

  11. Post-operative quality of life [Day 180]

    SF-36 and GIQLI

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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


Site City State Country Postal Code
1 Service de Chirurgie Colorectale Clichy Ile De France France 92110

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Fondation de l'Avenir


  • Principal Investigator: Yves PANIS, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris Identifier:
Other Study ID Numbers:
  • P111112
First Posted:
Oct 9, 2013
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021