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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04487600
Collaborator
(none)
130
Enrollment
2
Arms
7.1
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Active voiding trial
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Supportive Care
Official Title:
A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Aug 4, 2017
Actual Study Completion Date :
Aug 4, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Voiding Trial

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.

Other: Active voiding trial
No Intervention: Passive Voiding Trial

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.

Outcome Measures

Primary Outcome Measures

  1. length of hospital stay [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)]

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

Secondary Outcome Measures

  1. time to void [within 12 hours (720 minutes) following surgical procedure]

    Time (minutes) from Foley catheter removal to adequate voiding

  2. catheter replacement [within 24 hours (1440 minutes) following surgical procedure]

    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

  3. discomfort with voiding trial [within 12 hours (720 minutes) following surgical procedure]

    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.

  4. overnight admission [within 1 day following surgical procedure]

    planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Colleen Marie Feltmate, MD, BWPO Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04487600
Other Study ID Numbers:
  • 2015P000902
First Posted:
Jul 27, 2020
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Retention

Study Results

No Results Posted as of Jul 27, 2020