NCT03470870

Brief Summary

Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2020

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 13, 2018

Last Update Submit

March 13, 2018

Conditions

Gynecological Cancers

Keywords

Enhanced recovery after surgerygynecologic oncology surgeryNomogram control

Outcome Measures

Primary Outcomes (1)

  • Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

    Validation of a predictive nomogram of short-term hospitalization (less than two days after surgery)

    2 days

Secondary Outcomes (5)

  • Descriptive analysis of the cohort.

    1 day

  • Analysis of the factors influencing the variations of average length of stay.

    1 day

  • Analysis of the variation of the average duration of stay in time.

    1 day

  • Morbidity analysis of the ERAS program.

    1 day

  • Description of the implementation of the ERAS program on the entire cohort.

    1 day

Study Arms (2)

Patients discharged before 2 days after surgery

patients discharged before 2 days of hospitalization following surgery

Other: Comparative analysis of the characteristics

Patients discharged after 2 days after surgery

patients discharging after 2 days of hospitalization following surgery

Other: Comparative analysis of the characteristics

Interventions

Comparative analysis of the characteristicsOTHER

* Predictive nomogram of short-term hospitalization (less than two days after surgery) * Factors influencing the variations of average stay lenght * Morbidity of the ERAS program

Patients discharged after 2 days after surgeryPatients discharged before 2 days after surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who had surgery for gynecological cancer under the RAAC program.

You may qualify if:

  • All patients who had surgery for gynecological cancer under the ERAS program.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

Related Publications (24)

  • Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced Recovery Pathways for Improving Outcomes After Minimally Invasive Gynecologic Oncology Surgery. Obstet Gynecol. 2016 Jul;128(1):138-144. doi: 10.1097/AOG.0000000000001466.

    PMID: 27275797BACKGROUND

  • Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394.

    PMID: 24469618BACKGROUND

  • Yoong W, Sivashanmugarajan V, Relph S, Bell A, Fajemirokun E, Davies T, Munro K, Chigwidden K, Evan F, Lodhi W; Enhanced Recovery After Surgery (ERAS) Team for Gynaecology and Anaesthesia. Can enhanced recovery pathways improve outcomes of vaginal hysterectomy? Cohort control study. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):83-9. doi: 10.1016/j.jmig.2013.06.007. Epub 2013 Jul 10.

    PMID: 23850899BACKGROUND

  • Kroon UB, Radstrom M, Hjelthe C, Dahlin C, Kroon L. Fast-track hysterectomy: a randomised, controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):203-7. doi: 10.1016/j.ejogrb.2010.04.001. Epub 2010 May 10.

    PMID: 20452716BACKGROUND

  • Borendal Wodlin N, Nilsson L, Kjolhede P; GASPI study group. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):299-308. doi: 10.1111/j.1471-0528.2010.02697.x. Epub 2010 Sep 14.

    PMID: 20840529BACKGROUND

  • Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cardenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.

    PMID: 26386495BACKGROUND

  • Bruneau L, Randet M, Evrard S, Damon A, Laurent FX. [Total laparoscopic hysterectomy and same-day discharge: Satisfaction evaluation and feasibility study]. J Gynecol Obstet Biol Reprod (Paris). 2015 Nov;44(9):870-6. doi: 10.1016/j.jgyn.2015.02.003. Epub 2015 Mar 13. French.

    PMID: 25777619BACKGROUND

  • Chase DM, Lopez S, Nguyen C, Pugmire GA, Monk BJ. A clinical pathway for postoperative management and early patient discharge: does it work in gynecologic oncology? Am J Obstet Gynecol. 2008 Nov;199(5):541.e1-7. doi: 10.1016/j.ajog.2008.04.037. Epub 2008 Jun 2.

    PMID: 18513685BACKGROUND

  • Wijk L, Franzen K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

    PMID: 26799328BACKGROUND

  • Lindemann K, Kok PS, Stockler M, Jaaback K, Brand A. Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed. Int J Gynecol Cancer. 2017 Jul;27(6):1274-1282. doi: 10.1097/IGC.0000000000000981.

    PMID: 28498237BACKGROUND

  • Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

    PMID: 21597360BACKGROUND

  • Schlaerth AC, Abu-Rustum NR. Role of minimally invasive surgery in gynecologic cancers. Oncologist. 2006 Sep;11(8):895-901. doi: 10.1634/theoncologist.11-8-895.

    PMID: 16951393BACKGROUND

  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

    PMID: 26603969BACKGROUND

  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

    PMID: 26757238BACKGROUND

  • Miralpeix E, Nick AM, Meyer LA, Cata J, Lasala J, Mena GE, Gottumukkala V, Iniesta-Donate M, Salvo G, Ramirez PT. A call for new standard of care in perioperative gynecologic oncology practice: Impact of enhanced recovery after surgery (ERAS) programs. Gynecol Oncol. 2016 May;141(2):371-378. doi: 10.1016/j.ygyno.2016.02.019. Epub 2016 Mar 9.

    PMID: 26906066BACKGROUND

  • Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

    PMID: 27521884BACKGROUND

  • Bauchat JR, Habib AS. Evidence-based anesthesia for major gynecologic surgery. Anesthesiol Clin. 2015 Mar;33(1):173-207. doi: 10.1016/j.anclin.2014.11.011. Epub 2014 Dec 31.

    PMID: 25701935BACKGROUND

  • Touijer K, Scardino PT. Nomograms for staging, prognosis, and predicting treatment outcomes. Cancer. 2009 Jul 1;115(13 Suppl):3107-11. doi: 10.1002/cncr.24352.

    PMID: 19544538BACKGROUND

  • Potters L, Roach M 3rd, Davis BJ, Stock RG, Ciezki JP, Zelefsky MJ, Stone NN, Fearn PA, Yu C, Shinohara K, Kattan MW. Postoperative nomogram predicting the 9-year probability of prostate cancer recurrence after permanent prostate brachytherapy using radiation dose as a prognostic variable. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1061-5. doi: 10.1016/j.ijrobp.2009.03.031. Epub 2009 Jun 18.

    PMID: 19540064BACKGROUND

  • Nixon IJ, Ganly I, Hann LE, Lin O, Yu C, Brandt S, Shah JP, Shaha A, Kattan MW, Patel SG. Nomogram for predicting malignancy in thyroid nodules using clinical, biochemical, ultrasonographic, and cytologic features. Surgery. 2010 Dec;148(6):1120-7; discussion 1127-8. doi: 10.1016/j.surg.2010.09.030.

    PMID: 21134542BACKGROUND

  • Barsoum WK, Murray TG, Klika AK, Green K, Miniaci SL, Wells BJ, Kattan MW. Predicting patient discharge disposition after total joint arthroplasty in the United States. J Arthroplasty. 2010 Sep;25(6):885-92. doi: 10.1016/j.arth.2009.06.022. Epub 2009 Sep 2.

    PMID: 19729270BACKGROUND

  • Kelly DM, Bennett R, Brown N, McCoy J, Boerner D, Yu C, Eghtesad B, Barsoum W, Fung JJ, Kattan MW. Predicting the discharge status after liver transplantation at a single center: a new approach for a new era. Liver Transpl. 2012 Jul;18(7):796-802. doi: 10.1002/lt.23434.

    PMID: 22454258BACKGROUND

  • Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.

    PMID: 27353883BACKGROUND

  • Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.

    PMID: 23107080BACKGROUND

Study Officials

  • Eric LAMBAUDIE

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric LAMBAUDIE

CONTACT

0491225810LAMBAUDIEE@ipc.unicancer.fr

Jerome MATHIS

CONTACT

0491227792MATHISJ@ipc.unicancer.fr

Study Design

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

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

January 8, 2018

Primary Completion

January 8, 2020

Study Completion

February 8, 2020

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)