NCT01959087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2017

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

October 7, 2013

Last Update Submit

November 19, 2021

Conditions

Colonic NeoplasmsCrohn's DiseaseDiverticulitis

Keywords

Single port surgeryColonic surgeryPostoperative morbidityPostoperative outcomes

Outcome Measures

Primary Outcomes (1)

  • Length of postoperative hospital stay

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

    30 days

Secondary Outcomes (11)

  • Operative mortality

    30 days

  • Post-operative morbidity

    Day 30

  • Conversion rates

    Day 1

  • Pathologic results

    Day 180

  • Postoperative recovery

    30 days

  • +6 more secondary outcomes

Study Arms (2)

1: Single port surgery

EXPERIMENTAL

Surgery with single port

Procedure: single port surgeryProcedure: Multiport surgery

2: Multiport surgery

ACTIVE COMPARATOR

Surgery with multiport

Procedure: Multiport surgery

Interventions

single port surgeryPROCEDURE

Single port surgery can be converted in multiport surgery if necessary

1: Single port surgery
Multiport surgeryPROCEDURE
1: Single port surgery2: Multiport surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Colonic resection performed for benign or malignant colonic neoplasm, Crohn's disease, or diverticulitis
  • Informed consent signed
  • Social Insurance

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Colorectale

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

Location

Related Publications (1)

  • 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.

    PMID: 30303873DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsCrohn DiseaseDiverticulitis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesInflammatory Bowel DiseasesGastroenteritisDiverticular Diseases

Study Officials

  • Yves PANIS, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

January 27, 2014

Primary Completion

February 24, 2017

Study Completion

March 24, 2017

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations

FR(1)