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OpenTrials
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NCT Number: NCT04614519

Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.

This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.

Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.

Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.

Material and methods :

This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:

* Conventional group: insufflation pressure at 12mmHg and conventional instrumentation * LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.

Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.

Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.

Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product

Exclusion criteria

  • coagulopathy or thrombopathy
  • arguments for a complicated appendicitis: fever> 38.5 ° C, hyperleucytosis> 15,000, CRP> 100, presence of an intraperitoneal abscess, a plastron, a fluid effusion of medium or great abundance or '' a pneumoperitoneum on the CT scan
  • History of abdominal surgery by laparotomy
  • Obese patients (BMI> 30kg / m2)
  • minor patients
  • patients without health insurance
  • pregnant patient
  • patient incarcerated or in detention
  • patient under guardianship or curatorship
  • rapid sequence induction with the use of ketamine

Treatment and study plan

Conventional group

Procedure

Insufflation pressure at 12mmHg and conventional instrumentation

Low impact laparoscopy group

Procedure

Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation

Primary outcomes

  1. Post-operative pain decrease with low-impact laparoscopy

    Time frame: 30 days

    Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group.

Secondary outcomes

  1. Feasibility of Low Impact Laparoscopy in appendectomies

    Time frame: 30 days

    Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy

  2. Reduction in the average length of stay

    Time frame: 30 days

    Obtain a 10% reduction in the average length of stay between the 2 groups

  3. Decrease of opioids consumption

    Time frame: 30 days

    Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics

  4. Cost reduction in the LIL group

    Time frame: 30 days

    Equivalent operating time in the 2 groups

  5. Faster resumption of activities

    Time frame: 30 days

    Lower costs in the LIL group compared to the conventional group

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: LIL-APP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2020
Registry last updated
Mar 24, 2026

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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