Colonic NeoplasmsTRUENCT01959087
Single Port Colic Laparoscopic Surgery
A study testing single port surgery and Multiport surgery in people with Colonic Neoplasms and Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Crohn's Disease, Diverticulitis
- What is being tested?
- single port surgery and Multiport surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2014to 24 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
- Informed consent signed
- Social Insurance
Who cannot join
- 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
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- Synchronous metastasis
- Preoperative suspicion of T4 colorectal cancer
- Emergency procedure
- Associated resection (except appendectomy or liver biopsy)
- Pregnancy or current breast feeding.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Colorectale
Clichy, Île-de-France Region, 92110
About this study
Official title: Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.
Read the 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
- Conditions
- Colonic Neoplasms, Crohn's Disease, Diverticulitis
- Being tested
- single port surgery, Multiport surgery
- Keywords
- Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes
- Medical subject headings
- Colonic Neoplasms, Crohn Disease, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single port surgeryProcedure or surgery
Single port surgery can be converted in multiport surgery if necessary
Multiport surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1: Single port surgery | Experimental | Surgery with single port Receives: Procedure: single port surgery; Procedure: Multiport surgery |
| 2: Multiport surgery | Active comparator | Surgery with multiport Receives: Procedure: Multiport surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Theoretical duration of hospitalization (from the day of the surgery to the theoretical date of discharge
Measured: 30 days
Secondary outcomes (11)
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;
Measured: 30 days
Post-operative morbidity
Measured: Day 30
Conversion rates
Measured: Day 1
Pathologic results
Measured: Day 180
Postoperative recovery
Measured: 30 days
Postoperative pain
Measured: 6 days
Aesthetic results
Measured: 180 days
Costs
Measured: Day 180
Lenght of true hospitalization stay
Measured: 30 days
Technical feasability
Measured: Day 1
Post-operative quality of life
SF-36 and GIQLI
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study start27 Jan 2014
- Primary completion24 Feb 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Yves PANIS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959087
- Sponsor's protocol ID
- P111112
- Acronym
- TRUE
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2013
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30303873
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL
- ClinicalTrials.gov ID
- NCT01959087
- Acronym / sponsor ID
- TRUE / P111112
- Conditions
- Colonic Neoplasms, Crohn's Disease, Diverticulitis
- Keywords
- Single port surgery, Colonic surgery, Postoperative morbidity, Postoperative outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 27 Jan 2014 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Single port surgery | Experimental | Procedure: single port surgery, Procedure: Multiport surgerySurgery with single port |
| 2: Multiport surgery | Active comparator | Procedure: Multiport surgerySurgery with multiport |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
- Informed consent signed
- Social Insurance
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single port surgerySingle port surgery can be converted in multiport surgery if necessary | Procedure or surgery | 1: Single port surgery |
| Multiport surgery | Procedure or surgery | 1: Single port surgery, 2: Multiport surgery |
Primary outcome
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
11 secondary outcomes
Operative mortality
Time frame: 30 days
Post-operative morbidity
Time frame: Day 30
Conversion rates
Time frame: Day 1
Pathologic results
Time frame: Day 180
Postoperative recovery
Time frame: 30 days
Postoperative pain
Time frame: 6 days
Aesthetic results
Time frame: 180 days
Costs
Time frame: Day 180
Lenght of true hospitalization stay
Time frame: 30 days
Technical feasability
Time frame: Day 1
Post-operative quality of life
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 30303873Maggiori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves PANIS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single port surgery and Multiport surgery in people with Colonic Neoplasms and Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of postoperative hospital stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01959087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.