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The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial

Primary Purpose

Minimally Invasive Surgical Procedure, Hysterectomy, Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active voiding trial
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Minimally Invasive Surgical Procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease
  • planned same day discharge surgery

Exclusion Criteria:

  • history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding
  • bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria)
  • surgical cases converted to laparotomy or open surgery
  • Surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active Voiding Trial

    Passive Voiding Trial

    Arm Description

    At the completion of surgery, a Foley catheter was left in place. When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline. Voiding 200cc or (2/3) of the backfill amount was considered passing.

    At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.

    Outcomes

    Primary Outcome Measures

    length of hospital stay
    Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit

    Secondary Outcome Measures

    time to void
    Time (minutes) from Foley catheter removal to adequate voiding
    catheter replacement
    failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention
    discomfort with voiding trial
    average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.
    overnight admission
    planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)

    Full Information

    First Posted
    July 17, 2020
    Last Updated
    July 24, 2020
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04487600
    Brief Title
    The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial
    Official Title
    A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    August 4, 2017 (Actual)
    Study Completion Date
    August 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to investigate the impact of an active voiding trial compared to a passive voiding trial on time to discharge following a planned same day discharge laparoscopic hysterectomy. The investigators hypothesize that performing an active voiding trial will assess urinary function and lead to a reduction in length of stay.
    Detailed Description
    Following laparoscopic surgery with hysterectomy, there is no standard method for assuring urinary function prior to discharge. Total laparoscopic hysterectomy (TLH) has been demonstrated to be safe with a reduction in post-operative morbidity and length of hospital stay with no difference in cancer related outcomes in endometrial cancer. Furthermore, the investigators have demonstrated that following the adoption of same day discharge, there was no difference in composite complication rates or readmissions. Awaiting a passive void trial may impact time to discharge as well as same day discharge; however, this has not been clearly studied in this patient population. The aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery unit compared to a passive voiding trial with removal of the Foley catheter in the operating room at the end of the procedure. Secondary outcomes include time to void, catheter replacement, discomfort with the voiding trial, and overnight admission.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Minimally Invasive Surgical Procedure, Hysterectomy, Urinary Retention

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who were scheduled to undergo a same day discharge laparoscopic hysterectomy were assessed for eligibility to participate in this study. A computer generated blocked randomization schema was utilized with alternating block sizes to determine study groups. Participants were randomized 1:1 to each study group (active voiding trial vs. passive voiding trial). There was no cross-over between arms. If the participant did not receive the study intervention as allocated they were withdrawn from the study.
    Masking
    Investigator
    Masking Description
    Voiding trial protocols for each group (AVT and PVT) as well as data collection sheets were stored in sequentially numbered, opaque, sealed envelopes which were assigned after enrollment and were opened in the operating room at the completion of surgery by the surgical assistant. Attending surgeons and investigators were blinded to the individual patient study assignment. Due to the nature of the study, participants were not masked to their intervention.
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Voiding Trial
    Arm Type
    Experimental
    Arm Description
    At the completion of surgery, a Foley catheter was left in place. When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline. Voiding 200cc or (2/3) of the backfill amount was considered passing.
    Arm Title
    Passive Voiding Trial
    Arm Type
    No Intervention
    Arm Description
    At the completion of surgery, a Foley catheter was removed in the operating room. Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice. At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.
    Intervention Type
    Other
    Intervention Name(s)
    Active voiding trial
    Primary Outcome Measure Information:
    Title
    length of hospital stay
    Description
    Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit
    Time Frame
    within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)
    Secondary Outcome Measure Information:
    Title
    time to void
    Description
    Time (minutes) from Foley catheter removal to adequate voiding
    Time Frame
    within 12 hours (720 minutes) following surgical procedure
    Title
    catheter replacement
    Description
    failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention
    Time Frame
    within 24 hours (1440 minutes) following surgical procedure
    Title
    discomfort with voiding trial
    Description
    average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.
    Time Frame
    within 12 hours (720 minutes) following surgical procedure
    Title
    overnight admission
    Description
    planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
    Time Frame
    within 1 day following surgical procedure

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Given the nature of the surgery (gynecologic oncology surgery with hysterectomy) the study is limited to female participants
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease planned same day discharge surgery Exclusion Criteria: history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria) surgical cases converted to laparotomy or open surgery Surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified patient data and voiding protocols will be made available upon request via email to other researchers
    IPD Sharing Time Frame
    Data will be available upon request until the time of publication.
    IPD Sharing Access Criteria
    requests should be made via the study contact email.
    Citations:
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    Citation
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    Melamed A, Katz Eriksen JL, Hinchcliff EM, et al. Same-day discharge after laparoscopic hysterectomy for endometrial cancer. Gynecol Oncol. 2015;137(January 2015):37-38. doi:10.1016/j.ygyno.2015.01.088
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    The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial

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