Enhanced Recovery After Surgery: A RCT of Perioperative Management of Gynecologic Patients

NCT02357251 | Completed

• 1 other identifier: CASE 17814
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blinded randomized control trial comparing the current perioperative care of the investigators gynecologic oncology patients with a standardized perioperative "enhanced recovery" pathway. Adult patients undergoing laparotomy by one of the gynecologic oncology surgeons will be eligible to participate. The primary outcome will be length of hospitalization including any days of readmission in the 30 days post-operatively. Secondary outcomes will include 30-day readmission rate, complications, quality of recovery, and pain control.

Conditions

Laparotomy; Gynecologic Diseases

Outcome Measures

Primary Outcomes (1)

• Length of hospitalization

  Hospital days in first 30 days post-operatively (Length of stay of primary hospitalization plus any days of readmission)

  30 days post-operatively

Secondary Outcomes (4)

• Readmission rate

  30 days post-operatively

• Complications

  30 days post-operatively

• Quality of life/recovery

  30 days post-operatively

• Pain control

  30 days post-operatively

Study Arms (2)

Enhanced recovery protocol

ACTIVE COMPARATOR

Aspects of perioperative care will be standardized. Specific protocol for pre-operative, intra-operative, and post-operative care will be followed in this group.

Other: Enhanced recovery protocol

Standard of care

NO INTERVENTION

Treating physicians will determine all aspects of patients' perioperative care. Specifically, the individual surgeon, nurse, resident, fellow, and anesthesiologist caring for the patient will determine the patients' pre-operative counseling, bowel preparation, postoperative nausea and vomiting prophylaxis, IV fluid replacement, use of drains, timing of urinary catheter removal, mobilization, post-operative nutrition, pain medication, and bowel stimulation.

Interventions

Enhanced recovery protocol OTHER

Enhanced recovery protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are to undergo laparotomy

You may not qualify if:

• Inability to provide informed consent
• Inability to comprehend written or spoken English
• Immobility as defined by inability to ambulate unassisted
• Patient currently residing in a skilled nursing facility
• ASA physical status 4 or 5
• Planned greater than one night admission to the ICU
• Pregnancy

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kathryn Maurer, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: December 12, 2014
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

US (1)