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出境医 / 临床实验 / Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery (BDD RAAC)
Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery (BDD RAAC)
Study Description
Brief Summary:
Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).
| Condition or disease | Intervention/treatment |
|---|---|
| Oncology | Procedure: Enhanced recovery after surgery program |
Detailed Description:
This database would also allow an objective evaluation of the quality of the surgical management and the follow-up.
One of the evaluation criteria will be measured by the quantity and quality of publications from this database, and also by the increase in the activity of the service concerned.
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery |
| Actual Study Start Date : | January 1, 2016 |
| Estimated Primary Completion Date : | January 1, 2020 |
| Estimated Study Completion Date : | February 28, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
ERP
Any patient requiring oncologic surgery, including hysterectomy or curettage, posterior pelvectomy, conventional laparoscopic or assisted robotic surgery, or laparotomy for cervical or cervical cancer or ovarian cancer, body or cervix uterus and ovaries as well as benign pathologies or borderline malignancy.
|
Procedure: Enhanced recovery after surgery program
Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).
|
Outcome Measures
Primary Outcome Measures :
- Data collection [ Time Frame: 4 years ]Restrospective and prospective data collection
Secondary Outcome Measures :
- Evaluation of the quality of surgical management [ Time Frame: 4 days ]characteristics of the surgery according to the type of diagnosis
- Post-operative complications [ Time Frame: 4 days ]post-operative complications in hospitalization and post-operative complications after leaving hospital
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | uterine or cervical cancer or ovarian cancer |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.
Criteria
Inclusion Criteria:
- Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.
Exclusion Criteria:
- Non applicable.
Contacts and Locations
Contacts
| Contact: Dominique Genre | +33491223778 | drci.up@ipc.unicancer.fr |
Locations
| France | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, Bouches Du Rhone, France, 13009 | |
| Contact: Dominique Genre, MD 0033491223778 drci.up@ipc.unicancer.fr | |
| Principal Investigator: Eric Lambaudie, MD | |
Sponsors and Collaborators
Institut Paoli-Calmettes
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | September 20, 2018 | ||||||
| First Posted Date | May 14, 2019 | ||||||
| Last Update Posted Date | May 14, 2019 | ||||||
| Actual Study Start Date | January 1, 2016 | ||||||
| Estimated Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Data collection [ Time Frame: 4 years ] Restrospective and prospective data collection
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
|
||||||
| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery | ||||||
| Official Title | Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery | ||||||
| Brief Summary | Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS). | ||||||
| Detailed Description |
This database would also allow an objective evaluation of the quality of the surgical management and the follow-up. One of the evaluation criteria will be measured by the quantity and quality of publications from this database, and also by the increase in the activity of the service concerned. |
||||||
| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||
| Target Follow-Up Duration | 1 Year | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018. | ||||||
| Condition | Oncology | ||||||
| Intervention | Procedure: Enhanced recovery after surgery program
Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).
|
||||||
| Study Groups/Cohorts | ERP
Any patient requiring oncologic surgery, including hysterectomy or curettage, posterior pelvectomy, conventional laparoscopic or assisted robotic surgery, or laparotomy for cervical or cervical cancer or ovarian cancer, body or cervix uterus and ovaries as well as benign pathologies or borderline malignancy.
Intervention: Procedure: Enhanced recovery after surgery program
|
||||||
| Publications * | Lambaudie E, de Nonneville A, Brun C, Laplane C, N'Guyen Duong L, Boher JM, Jauffret C, Blache G, Knight S, Cini E, Houvenaeghel G, Blache JL. Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center. BMC Surg. 2017 Dec 28;17(1):136. doi: 10.1186/s12893-017-0332-9. | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status | Unknown status | ||||||
| Estimated Enrollment |
500 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | February 28, 2020 | ||||||
| Estimated Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Sex/Gender |
|
||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03950011 | ||||||
| Other Study ID Numbers | BDD RAAC-IPC 2016-011 2174848 ( Other Identifier: CNIL ) |
||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Institut Paoli-Calmettes | ||||||
| Study Sponsor | Institut Paoli-Calmettes | ||||||
| Collaborators | Not Provided | ||||||
| Investigators | Not Provided | ||||||
| PRS Account | Institut Paoli-Calmettes | ||||||
| Verification Date | May 2019 | ||||||
