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Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection (LoPreCol)

Primary Purpose

Colonic Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Conventional pressure laparoscopy
Low pressure laparoscopy
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Colic lesion justifying surgical resection by segmental colectomy,
  • Surgery proposed by laparoscopy,
  • Body mass index (BMI) ≤30 kg/m2,
  • Written informed consent signed by the patient,
  • Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.

Exclusion Criteria:

  • Probable realization of a stoma during the procedure,
  • Robot-assisted approach,
  • Contraindication to laparoscopic surgery,
  • Pregnant or likely to be pregnant,
  • Patient deprived of liberty or placed under the authority of a tutor,
  • Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.

Sites / Locations

  • Institut Paoli CalmettesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional laparoscopy

Low pressure laparoscopy

Arm Description

Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator.

Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal®

Outcomes

Primary Outcome Measures

The theoretical hospital stay
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)

Secondary Outcome Measures

Morbidity rate
Morbidity evaluated according Dindo-clavien classification
Mortality rate
Dead patient listing
GastroIntestinal-Quality-of-Life Index (GIQLI)
GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Short Form Health (SF12) score
This questionnaire is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Pain score using self-report pain assessment tool (EVA)
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
Intestinal transit recovery time frame
Period duration from surgery to intestinal gas recovery time (in days)
Nausea and vomiting incidence
Nausea and vomiting listing
Analgesic treatment incidence
Non-morphine and morphine analgesic consumption
Real hospitalization duration
Real hospitalization duration (actual patient discharge date based on non-medical criteria)
Rehospitalization number
Rehospitalization listing
Differential cost of patient care
According operating room occupation and real hospital stay

Full Information

First Posted
September 25, 2019
Last Updated
March 8, 2022
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT04112654
Brief Title
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
Acronym
LoPreCol
Official Title
Prospective Randomized Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
June 29, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional laparoscopy
Arm Type
Active Comparator
Arm Description
Laparoscopy realized at the conventional pressure (12-15 mmHg) using conventional insufflator.
Arm Title
Low pressure laparoscopy
Arm Type
Experimental
Arm Description
Laparoscopy realized at low pressure (6-8mmHg) using pressure-controlled insufflator AirSeal®
Intervention Type
Procedure
Intervention Name(s)
Conventional pressure laparoscopy
Intervention Description
Conventional pressure laparoscopy using conventional insufflator AirSeal®
Intervention Type
Procedure
Intervention Name(s)
Low pressure laparoscopy
Intervention Description
Low pressure laparoscopy using pressure-controlled insufflator AirSeal®
Primary Outcome Measure Information:
Title
The theoretical hospital stay
Description
The theoretical hospital stay in days (calculated from the day of the surgery to the theoretical day of discharge according to predefined exit criteria)
Time Frame
from hospitalization day until hospital discharge, assessed up to 15 days
Secondary Outcome Measure Information:
Title
Morbidity rate
Description
Morbidity evaluated according Dindo-clavien classification
Time Frame
20 days post surgery
Title
Mortality rate
Description
Dead patient listing
Time Frame
20 days post surgery
Title
GastroIntestinal-Quality-of-Life Index (GIQLI)
Description
GastroIntestinal-Quality-of-Life Index (GIQLI) questionnaire, 36 questions, each containing 4 answers equating to a score ranging from 0 (least desirable answer) to 4 (most desirable answer). Total score range 0-144.
Time Frame
20 days and 3 months post surgery
Title
Short Form Health (SF12) score
Description
This questionnaire is an abbreviated version of the "Medical Outcomes Study Short-Form General Health Survey" (SF-36) contains only 12 items out of 36 with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Time Frame
20 days and 3 months post surgery
Title
Pain score using self-report pain assessment tool (EVA)
Description
EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)
Time Frame
From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery
Title
Intestinal transit recovery time frame
Description
Period duration from surgery to intestinal gas recovery time (in days)
Time Frame
From surgery to transit recovery assessed up to 15 days
Title
Nausea and vomiting incidence
Description
Nausea and vomiting listing
Time Frame
From surgery to hospital discharge assessed up to 15 days
Title
Analgesic treatment incidence
Description
Non-morphine and morphine analgesic consumption
Time Frame
From surgery to 3 months post surgery
Title
Real hospitalization duration
Description
Real hospitalization duration (actual patient discharge date based on non-medical criteria)
Time Frame
From hospitalization day until hospital discharge assessed up to 15 days
Title
Rehospitalization number
Description
Rehospitalization listing
Time Frame
from hospital discharge assessed up to 15 days to 3 months post surgery
Title
Differential cost of patient care
Description
According operating room occupation and real hospital stay
Time Frame
From surgery to hospital discharge assessed up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colic lesion justifying surgical resection by segmental colectomy, Surgery proposed by laparoscopy, Body mass index (BMI) ≤30 kg/m2, Written informed consent signed by the patient, Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen. Exclusion Criteria: Probable realization of a stoma during the procedure, Robot-assisted approach, Contraindication to laparoscopic surgery, Pregnant or likely to be pregnant, Patient deprived of liberty or placed under the authority of a tutor, Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33491223778
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile DE CHAISEMARTIN, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Bouches Du Rhone
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Genre, MD
Phone
0033491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Cecile DE CHAISEMARTIN, MD

12. IPD Sharing Statement

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Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

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