NCT04112654

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.

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 Jun 2020

Longer than P75 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

September 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

September 25, 2019

Last Update Submit

April 8, 2024

Conditions

Colonic Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

    from hospitalization day until hospital discharge, assessed up to 15 days

Secondary Outcomes (11)

  • Morbidity rate

    20 days post surgery

  • Mortality rate

    20 days post surgery

  • GastroIntestinal-Quality-of-Life Index (GIQLI)

    20 days and 3 months post surgery

  • Short Form Health (SF12) score

    20 days and 3 months post surgery

  • Pain score using self-report pain assessment tool (EVA)

    From surgery to hospital discharge assessed up to 15 days, at 20 days and at 3 months post surgery

  • +6 more secondary outcomes

Study Arms (2)

Conventional laparoscopy

ACTIVE COMPARATOR

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

Procedure: Conventional pressure laparoscopy

Low pressure laparoscopy

EXPERIMENTAL

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

Procedure: Low pressure laparoscopy

Interventions

Conventional pressure laparoscopyPROCEDURE

Conventional pressure laparoscopy using conventional insufflator AirSeal®

Conventional laparoscopy
Low pressure laparoscopyPROCEDURE

Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Low pressure laparoscopy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Cecile DE CHAISEMARTIN, MD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 2, 2019

Study Start

June 29, 2020

Primary Completion

June 7, 2023

Study Completion

October 18, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

FR(1)