Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

S

Shandong University

Status

Completed

Conditions

Gynecologic Cancer
Gynecologic Disease

Treatments

Procedure: ERAS protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03629626
ERASGS-01

Details and patient eligibility

About

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

Full description

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Enrollment

540 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age >18 and <70 years old
  • Patients candidated for elective gynecological surgery for benign pathology
  • Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
  • Signed consent form

Exclusion criteria

  • Contraindication to loco-regional anaesthesia
  • Patients with ileus or subocclusive condition prior surgery
  • Coagulation disorders
  • Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
  • Uncontrolled hypertension (>180/95)
  • Alcohol or drug abuser (current or previous)
  • Psychiatric condition or language barriers
  • Planned Intensive Care Recovery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

540 participants in 2 patient groups

Conventional Perioperative (SP) care
No Intervention group
Description:
Conventional Perioperative (SP) care
ERAS protocol
Experimental group
Description:
preoperative / intraoperative/ postoperative management
Treatment:
Procedure: ERAS protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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