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Completed

NCT Number: NCT01959087

Single Port Colic Laparoscopic Surgery

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

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Crohn Disease Crohn's Disease Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Colorectale

Clichy, Île-de-France Region, 92110, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

single port surgery

Procedure

Single port surgery can be converted in multiport surgery if necessary

Multiport surgery

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study title

Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

Acronym: TRUE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2013
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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