Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study

NCT ID: NCT01705288

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2016-08-24

Brief Summary

Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.

Detailed Description

Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).

Conditions

Cervical Cancer; Uterine Endometrial Cancer; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group (Standard Laparotomy)

Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.

Group Type: ACTIVE_COMPARATOR

Laparotomy

Intervention Type: PROCEDURE

Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital

intravenous narcotics

Intervention Type: DRUG

given for pain management after surgery per physician orders

standard anesthesia

Intervention Type: DRUG

inhalant or intravenous during surgery

Rapid Recovery Group

Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.

Group Type: EXPERIMENTAL

Laparotomy

Intervention Type: PROCEDURE

Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital

regional anesthesia

Intervention Type: DRUG

given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs

Intervention Type: DRUG

given for pain management after surgery

Interventions

Laparotomy

Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital

Intervention Type: PROCEDURE

intravenous narcotics

given for pain management after surgery per physician orders

Intervention Type: DRUG

standard anesthesia

inhalant or intravenous during surgery

Intervention Type: DRUG

regional anesthesia

given by spinal or epidural infusion

Intervention Type: DRUG

Non-steroidal anti-inflammatory drugs

given for pain management after surgery

Intervention Type: DRUG

Other Intervention Names

morphine; general anesthesia; local anesthesia; NSAIDs

Eligibility Criteria

Inclusion Criteria

• Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy

Exclusion Criteria

• < 19 years old
• Pregnant
• Undergoing a procedure other than laparotomy
• Scheduled to be discharged the same day of surgery
• Chronic narcotic pain medication user
• American Society of Anesthesiologists (ASA) score of > or = 3
• Any condition that would exclude women from undergoing regional anesthesia

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Argenta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.

Reference Type: DERIVED

PMID: 35289396 (View on PubMed)

Dickson EL, Stockwell E, Geller MA, Vogel RI, Mullany SA, Ghebre R, Witherhoff BJ, Downs LS Jr, Carson LF, Teoh D, Glasgow M, Gerber M, Rivard C, Erickson BK, Hutchins J, Argenta PA. Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):355-362. doi: 10.1097/AOG.0000000000001838.

Reference Type: DERIVED

PMID: 28079776 (View on PubMed)

Other Identifiers

2012LS096

Identifier Type: -

Identifier Source: org_study_id