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NCT Number: NCT04112654

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

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.

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Key information

Conditions

Colonic Disease Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional pressure laparoscopy

Procedure

Conventional pressure laparoscopy using conventional insufflator AirSeal®

Low pressure laparoscopy

Procedure

Low pressure laparoscopy using pressure-controlled insufflator AirSeal®

Primary outcomes

  1. The theoretical hospital stay

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

    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 outcomes

  1. Morbidity rate

    Time frame: 20 days post surgery

    Morbidity evaluated according Dindo-clavien classification

  2. Mortality rate

    Time frame: 20 days post surgery

    Dead patient listing

  3. GastroIntestinal-Quality-of-Life Index (GIQLI)

    Time frame: 20 days and 3 months post surgery

    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.

  4. Short Form Health (SF12) score

    Time frame: 20 days and 3 months post surgery

    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).

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

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

    EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)

  6. Intestinal transit recovery time frame

    Time frame: From surgery to transit recovery assessed up to 15 days

    Period duration from surgery to intestinal gas recovery time (in days)

  7. Nausea and vomiting incidence

    Time frame: From surgery to hospital discharge assessed up to 15 days

    Nausea and vomiting listing

  8. Analgesic treatment incidence

    Time frame: From surgery to 3 months post surgery

    Non-morphine and morphine analgesic consumption

  9. Real hospitalization duration

    Time frame: From hospitalization day until hospital discharge assessed up to 15 days

    Real hospitalization duration (actual patient discharge date based on non-medical criteria)

  10. Rehospitalization number

    Time frame: from hospital discharge assessed up to 15 days to 3 months post surgery

    Rehospitalization listing

  11. Differential cost of patient care

    Time frame: From surgery to hospital discharge assessed up to 15 days

    According operating room occupation and real hospital stay

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: LoPreCol

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2019
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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