CHU de Nice
Nice, France
NCT Number: NCT04614519
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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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Nice, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insufflation pressure at 12mmHg and conventional instrumentation
Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
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.
Time frame: 30 days
Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy
Time frame: 30 days
Obtain a 10% reduction in the average length of stay between the 2 groups
Time frame: 30 days
Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics
Time frame: 30 days
Equivalent operating time in the 2 groups
Time frame: 30 days
Lower costs in the LIL group compared to the conventional group
Centre Hospitalier Universitaire de Nice
Other
Acronym: LIL-APP
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