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

NCT04487600 | Completed

• 1 other identifier: 2015P000902
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Minimally Invasive Surgical Procedure; Hysterectomy; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

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

  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 Outcomes (4)

• time to void

  within 12 hours (720 minutes) following surgical procedure

• catheter replacement

  within 24 hours (1440 minutes) following surgical procedure

• discomfort with voiding trial

  within 12 hours (720 minutes) following surgical procedure

• overnight admission

  within 1 day following surgical procedure

Study Arms (2)

Active Voiding Trial

EXPERIMENTAL

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

Passive Voiding Trial

NO INTERVENTION

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.

Interventions

Active voiding trial OTHER

Active Voiding Trial

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Given the nature of the surgery (gynecologic oncology surgery with hysterectomy) the study is limited to female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (15)

• Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, Patel PR. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):656-61. doi: 10.1016/j.jmig.2014.01.012. Epub 2014 Jan 24.

  PMID: 24462854 BACKGROUND

• Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB. The impact of different surgical modalities for hysterectomy on satisfaction and patient reported outcomes. Interact J Med Res. 2014 Jul 17;3(3):e11. doi: 10.2196/ijmr.3160.

  PMID: 25048103 BACKGROUND

• Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.

  PMID: 23107080 BACKGROUND

• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.

  PMID: 19805679 BACKGROUND

• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30.

  PMID: 22291074 BACKGROUND

• Melamed A, Katz Eriksen JL, Hinchcliff EM, Worley MJ Jr, Berkowitz RS, Horowitz NS, Muto MG, Urman RD, Feltmate CM. Same-Day Discharge After Laparoscopic Hysterectomy for Endometrial Cancer. Ann Surg Oncol. 2016 Jan;23(1):178-85. doi: 10.1245/s10434-015-4582-4. Epub 2015 May 9.

  PMID: 25956576 BACKGROUND

• Nahas S, Feigenberg T, Park S. Feasibility and safety of same-day discharge after minimally invasive hysterectomy in gynecologic oncology: A systematic review of the literature. Gynecol Oncol. 2016 Nov;143(2):439-442. doi: 10.1016/j.ygyno.2016.07.113. Epub 2016 Jul 27.

  PMID: 27475523 BACKGROUND

• Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.

  PMID: 25210477 BACKGROUND

• Foundation W-BF. Wong-Baker FACES® Pain Rating Scale. 2016

  BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.

  PMID: 17980330 RESULT

• Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.

  PMID: 21860294 RESULT

• Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.

  PMID: 18060956 RESULT

• Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.

  PMID: 20727543 RESULT

• Alessandri F, Mistrangelo E, Lijoi D, Ferrero S, Ragni N. A prospective, randomized trial comparing immediate versus delayed catheter removal following hysterectomy. Acta Obstet Gynecol Scand. 2006;85(6):716-20. doi: 10.1080/00016340600606976.

  PMID: 16752265 RESULT

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BWPO Physician

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 27, 2020
• Study Start: January 1, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available upon request until the time of publication.
• Access Criteria: requests should be made via the study contact email.