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Single Port Colic Laparoscopic Surgery

NCT ID: NCT01959087

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-27

Study Completion Date

2017-03-24

Brief Summary

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

Detailed Description

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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

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Colonic Neoplasms Crohn's Disease Diverticulitis

Keywords

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Single port surgery Colonic surgery Postoperative morbidity Postoperative outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1: Single port surgery

Surgery with single port

Group Type EXPERIMENTAL

single port surgery

Intervention Type PROCEDURE

Single port surgery can be converted in multiport surgery if necessary

Multiport surgery

Intervention Type PROCEDURE

2: Multiport surgery

Surgery with multiport

Group Type ACTIVE_COMPARATOR

Multiport surgery

Intervention Type PROCEDURE

Interventions

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single port surgery

Single port surgery can be converted in multiport surgery if necessary

Intervention Type PROCEDURE

Multiport surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de l'Avenir

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves PANIS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Chirurgie Colorectale

Clichy, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30303873 (View on PubMed)

Other Identifiers

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P111112

Identifier Type: -

Identifier Source: org_study_id