NCT04505111

Brief Summary

Prospective, interventionist, controlled and randomized study to test the effectiveness of multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 23, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

July 30, 2020

Last Update Submit

April 2, 2022

Conditions

Gynecologic Surgical ProceduresEnhanced Recovery After Surgery

Keywords

PrehabilitationGynecological CancerERAS - Enhanced Recovery After SurgeryGynecologic Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative recovery time

    Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs

    Up to 30 postoperative days

Secondary Outcomes (10)

  • Complications

    Up to 30 postoperative days

  • Readmissions

    Up to 30 postoperative days

  • Intensive Care Unit admission rates

    Up to 30 postoperative days

  • Health-related Quality of Life

    At Baseline, then at 30 and 60 days postoperatively

  • Compliance to the ERAS® program guidelines

    Through study completion, an average of 1 year

  • +5 more secondary outcomes

Study Arms (2)

Prehabilitation + Enhanced Recovery After Surgery

EXPERIMENTAL

Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.

Other: Prehabilitation Program + Enhanced Recovery After Surgery

Enhanced Recovery After Surgery

ACTIVE COMPARATOR

Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.

Other: Enhanced Recovery After Surgery

Interventions

Prehabilitation Program + Enhanced Recovery After SurgeryOTHER

Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol

Also known as: Prehabilitation + ERAS
Prehabilitation + Enhanced Recovery After Surgery
Enhanced Recovery After SurgeryOTHER

ERAS protocol

Also known as: ERAS
Enhanced Recovery After Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
  • Women aged between 18 and 80 years old;
  • Gynecological surgery performed by laparotomy;
  • Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
  • Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks

You may not qualify if:

  • Patients under 18 or older than 80 years old;
  • ECOG ≥3;
  • Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
  • Limitation of locomotion preventing the patient to perform physical exercises;
  • Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
  • Emergency or urgency surgeries;
  • Surgeries by minimally invasive approach (laparoscopy or robotics);
  • Vulvectomy or soft tissue surgery without abdominal approach;
  • Minor gynaecological surgeries such as conizations;
  • Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
  • Non-adherence of the patient in the intervention group to the preoperative prehabilitation program.
  • If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, São Paulo, 03102-002, Brazil

Location

Related Publications (10)

  • Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.

    PMID: 25076007BACKGROUND

  • Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.

    PMID: 24439570BACKGROUND

  • Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

    PMID: 28489682BACKGROUND

  • 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

  • Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

    PMID: 30877144BACKGROUND

  • Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.

    PMID: 14555665BACKGROUND

  • Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.

    PMID: 25535730BACKGROUND

  • Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.

    PMID: 31473663BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

MeSH Terms

Interventions

Enhanced Recovery After SurgeryPreoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, OperativePatient CareTherapeuticsExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Andre Lopes, MD

    Doctor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single-Blind (surgeons and anesthesiologists)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 10, 2020

Study Start

July 23, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

After publication of the results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After study enrollment
Access Criteria
Public

Locations

BR(1)