Peri-operative Analgesia for Single-incision Laparoscopic Appendectomy

NCT05773521 | Unknown

• 1 other identifier: 2022-124
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic appendectomy is a very common intervention in pediatric surgery. To improve outcomes, some teams have developed the use of single-site laparoscopic appendectomy (SILAP). Nevertheless, there is no consensus yet and no published data on the better perioperative analgesia, and different modalities including general intravenous analgesia, locoregional pre-operative analgesia and local analgesia can be used.

Conditions

Appendicitis

Keywords

appendectomy; single-site laparoscopy; analgesia; pain; peri-operative management

Outcome Measures

Primary Outcomes (1)

• To assess the level of pain after SILAP during the 24 first hours after surgery.

  Objectified by the quantity of level 2-3 (in morphin equivalent) analgesic used up to 24 hours after surgery.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

Secondary Outcomes (5)

• To assess the level of pain as measured by the different pain scales routinely used.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

• To assess the level of pain during the initial post-operative recovery room stay.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

• To assess the level of pain after the 24 first hours and until hospital release.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

• To assess the different peri-operative local and loco-regional analgesia modalities used and to compare their efficiency.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

• To assess the types and gravity of peri-operative and post-analgesia complications.

  Up to 16 years of age. From the date of surgery until the end of hospital stay, assessed up to 16 years of age

Study Arms (1)

SILAP patients

This cohort is composed by all pediatric patients operated on for SILAP between January 1st, 2012 and August 31, 2022.

Procedure: SILAP (single incision laparoscopic appendectomy)

Interventions

SILAP (single incision laparoscopic appendectomy) PROCEDURE

Appendectomy performed through transumbilical single access laparoscopy, consisting in the removal of the appendix.

SILAP patients

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients operated on by single-site access for laparoscopic appendectomy.

You may qualify if:

• All patients operated on for appendectomy by SILAP, aged 15 years and under in our pediatric surgical center.

You may not qualify if:

• Patients aged 16 years or more.
• Patients with concomitant pathologies potentially inducing hyper- or hypoesthesia (e.g. cancers, spinal cord injury, etc...)
• Patients with contraindications for the use of IV analgesics.
• patients operated on for appendectomy through 3-ports laparoscopy or open surgery.
• Opposition of the patients and their representative to the study.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49933, France

Location

Related Publications (2)

• Goodman LF, Lin AC, Sacks MA, McRae JJLH, Radulescu A, Khan FA. Single site versus conventional laparoscopic appendectomy: some pain for no gain? J Surg Res. 2021 Aug;264:321-326. doi: 10.1016/j.jss.2021.03.010. Epub 2021 Apr 10.

  PMID: 33848830 BACKGROUND

• Binet A, Braik K, Lengelle F, Laffon M, Lardy H, Amar S. Laparoscopic one port appendectomy: Evaluation in pediatric surgery. J Pediatr Surg. 2018 Nov;53(11):2322-2325. doi: 10.1016/j.jpedsurg.2017.12.018. Epub 2017 Dec 27.

  PMID: 29370892 BACKGROUND

MeSH Terms

Conditions

Appendicitis; Agnosia; Pain

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Françoise Schmitt, MD, PhD

  University hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Goulin, MD

CONTACT

+33 2 41 35 42 90; jeanne.goulin@chu-angers.fr

Françoise Schmitt, MD-PhD

CONTACT

+33 2 41 35 42 90; FrSchmitt@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: August 31, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)