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Single Port Colic Laparoscopic Surgery (TRUE)

Primary Purpose

Colonic Neoplasms, Crohn's Disease, Diverticulitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
single port surgery
Multiport surgery
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms focused on measuring Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Service de Chirurgie Colorectale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Single port surgery

2: Multiport surgery

Arm Description

Surgery with single port

Surgery with multiport

Outcomes

Primary Outcome Measures

Length of postoperative hospital stay
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge

Secondary Outcome Measures

Operative mortality
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;
Post-operative morbidity
Conversion rates
Pathologic results
Postoperative recovery
Postoperative pain
Aesthetic results
Costs
Lenght of true hospitalization stay
Technical feasability
Post-operative quality of life
SF-36 and GIQLI

Full Information

First Posted
October 7, 2013
Last Updated
November 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT01959087
Brief Title
Single Port Colic Laparoscopic Surgery
Acronym
TRUE
Official Title
Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2014 (Actual)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de l'Avenir

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Crohn's Disease, Diverticulitis
Keywords
Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Single port surgery
Arm Type
Experimental
Arm Description
Surgery with single port
Arm Title
2: Multiport surgery
Arm Type
Active Comparator
Arm Description
Surgery with multiport
Intervention Type
Procedure
Intervention Name(s)
single port surgery
Intervention Description
Single port surgery can be converted in multiport surgery if necessary
Intervention Type
Procedure
Intervention Name(s)
Multiport surgery
Primary Outcome Measure Information:
Title
Length of postoperative hospital stay
Description
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Operative mortality
Description
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;
Time Frame
30 days
Title
Post-operative morbidity
Time Frame
Day 30
Title
Conversion rates
Time Frame
Day 1
Title
Pathologic results
Time Frame
Day 180
Title
Postoperative recovery
Time Frame
30 days
Title
Postoperative pain
Time Frame
6 days
Title
Aesthetic results
Time Frame
180 days
Title
Costs
Time Frame
Day 180
Title
Lenght of true hospitalization stay
Time Frame
30 days
Title
Technical feasability
Time Frame
Day 1
Title
Post-operative quality of life
Description
SF-36 and GIQLI
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves PANIS, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Colorectale
City
Clichy
State/Province
Ile De France
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30303873
Citation
Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.
Results Reference
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Single Port Colic Laparoscopic Surgery

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