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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional group | Active Comparator | Insufflation pressure at 12mmHg and conventional instrumentation |
|
| Low impact laparoscopy group | Experimental | Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional group | Procedure | Insufflation pressure at 12mmHg and conventional instrumentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain decrease with low-impact laparoscopy | Decrease of 2 points on a numerical pain scale of 0 to 10 in the LIL group compared to the conventional group. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Low Impact Laparoscopy in appendectomies | Possibility of performing at least 80% of LIL procedures without conversion to conventional laparoscopy | 30 days |
| Reduction in the average length of stay |
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Inclusion Criteria:
- Patients with acute appendicitis uncomplicated by computed tomography with injection of contrast product
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37382370 | Result | Etienne JH, Salucki B, Gridel V, Orban JC, Baque P, Massalou D. Low-Impact Laparoscopy vs Conventional Laparoscopy for Appendectomy: A Prospective Randomized Trial. J Am Coll Surg. 2023 Oct 1;237(4):622-631. doi: 10.1097/XCS.0000000000000795. Epub 2023 Jun 29. |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| Low impact laparoscopy group | Procedure | Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation |
|
Obtain a 10% reduction in the average length of stay between the 2 groups
| 30 days |
| Decrease of opioids consumption | Obtain a 10% reduction in the consumption of level 2 and 3 perioperative analgesics | 30 days |
| Cost reduction in the LIL group | Equivalent operating time in the 2 groups | 30 days |
| Faster resumption of activities | Lower costs in the LIL group compared to the conventional group | 30 days |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |