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Cervical CancerEarly Phase 1NCT01705288

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

A Early Phase 1 study testing Laparotomy, intravenous narcotics and standard anesthesia in people with Cervical Cancer and Uterine Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Laparotomy, intravenous narcotics and standard anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteUnited States
Study dates
1 Jan 2013to 24 Aug 2016
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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.

Read the 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).

Being tested
Laparotomy, intravenous narcotics, standard anesthesia, regional anesthesia, Non-steroidal anti-inflammatory drugs
Keywords
laparotomy, hysterectomy
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaparotomyProcedure or surgery

    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 narcoticsDrug

    Also called morphine

    given for pain management after surgery per physician orders

  • standard anesthesiaDrug

    Also called general anesthesia

    inhalant or intravenous during surgery

  • regional anesthesiaDrug

    Also called local anesthesia

    given by spinal or epidural infusion

  • Non-steroidal anti-inflammatory drugsDrug

    Also called NSAIDs

    given for pain management after surgery

Study groups in NCT01705288
Study groupRoleWhat they receive
Control Group (Standard Laparotomy)Active comparatorPatients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Receives: Procedure: Laparotomy; Drug: intravenous narcotics; Drug: standard anesthesia
Rapid Recovery GroupExperimentalProtocol 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.
Receives: Procedure: Laparotomy; Drug: regional anesthesia; Drug: Non-steroidal anti-inflammatory drugs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Stay

    Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge

    Measured: 1 Month

Secondary outcomes (2)

  1. Pain Medications Used

    Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.

    Measured: Post operative - day 2

  2. Pain Assessment

    Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study start1 Jan 2013
  3. Primary completion24 Aug 2016
  4. Study completion24 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705288
Sponsor's protocol ID
2012LS096
Status last verified
Feb 2020
First submitted
9 Oct 2012
Last updated
17 Feb 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35289396

  • 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.

    PubMed 28079776

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Laparotomy, intravenous narcotics and standard anesthesia in people with Cervical Cancer and Uterine Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Stay (time frame: 1 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705288, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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