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NCT04165148: RANDOLIL
Low Impact Laparoscopy Concept Versus Conventional Laparoscopy
NA trial testing Low Impact Laparoscopy in Ambulatory Laparoscopic Hysterectomy in 2 participants. Terminated before completion.
3 January 2023
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 3 June 2020 |
| Primary completion | 3 January 2023 |
| Estimated completion | 3 September 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Low Impact Laparoscopy
- conventional laparoscopy
- Visual Analog Scale (VAS) for Pain
- Saint-Antoine Pain Questionnaire (QDSA)
- post-operative questionnaire
Conditions studied
- Ambulatory Laparoscopic Hysterectomy — all drugs for Ambulatory Laparoscopic Hysterectomy →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, female only, with Ambulatory Laparoscopic Hysterectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS. The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain. The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased. The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy. The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04165148
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04165148 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 18 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04165148.
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