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

NCT ID: NCT04112654

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2023-10-18

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.

Conditions

Colonic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional laparoscopy

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

Group Type: ACTIVE_COMPARATOR

Conventional pressure laparoscopy

Intervention Type: PROCEDURE

Conventional pressure laparoscopy using conventional insufflator AirSeal®

Low pressure laparoscopy

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

Group Type: EXPERIMENTAL

Low pressure laparoscopy

Intervention Type: PROCEDURE

Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Interventions

Conventional pressure laparoscopy

Conventional pressure laparoscopy using conventional insufflator AirSeal®

Intervention Type: PROCEDURE

Low pressure laparoscopy

Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecile DE CHAISEMARTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Countries

France

Other Identifiers

LOPRECOL-IPC 2017-02

Identifier Type: OTHER

Identifier Source: secondary_id

LOPRECOL-IPC 2017-02

Identifier Type: -

Identifier Source: org_study_id