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NCT01705288

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

Completed EARLY_PHASE1 Results posted Last updated 17 February 2020
What this trial tests

EARLY_PHASE1 trial testing Laparotomy in Cervical Cancer in 103 participants. Completed in 24 August 2016.

Timeline
1 January 2013
Primary endpoint
24 August 2016
24 August 2016

Quick facts

Lead sponsorMasonic Cancer Center, University of Minnesota
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment103
Start date1 January 2013
Primary completion24 August 2016
Estimated completion24 August 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

19 and older, any sex, with Cervical Cancer or Uterine Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospital Stay Primary · 1 Month

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

GroupValue95% CI
Control Group (Standard Laparotomy)3.02.0 – 3.0
Rapid Recovery Group3.02.0 – 3.0
Pain Medications Used Secondary · Post operative - day 2

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

GroupValue95% CI
Control Group (Standard Laparotomy)10.08.3 – 12.3
Rapid Recovery Group7.53.3 – 10.0
Pain Assessment Secondary · Day 0

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.

GroupValue95% CI
Control Group (Standard Laparotomy)4.333.0 – 6.25
Rapid Recovery Group3.132.30 – 4.40

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group (Standard Laparotomy)
Serious: 1/52 (2%)
Deaths:
Rapid Recovery Group
Serious: 4/51 (8%)
Deaths:

Serious adverse events (2 terms)

ReactionSystemControl Group (Standard La…Rapid Recovery Group
ICU admissionGeneral disorders
HemorrhageBlood and lymphatic system disorders
Other adverse events (1 terms — click to expand)

ReactionSystemControl Group (Standard La…Rapid Recovery Group
Individual adverse events breakup not knownGeneral disorders

Most-reported serious reactions: ICU admission, Hemorrhage.

Data from ClinicalTrials.gov NCT01705288 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial.
    Dickson EL, Stockwell E, Geller MA, Vogel RI, et al · · 2017 · cited 40× · PMID 28079776 · DOI 10.1097/aog.0000000000001838
  2. Perioperative enhanced recovery programmes for women with gynaecological cancers.
    Chau JPC, Liu X, Lo SHS, Chien WT, et al · · 2022 · cited 13× · PMID 35289396 · DOI 10.1002/14651858.cd008239.pub5

Verify or expand the search:

Other trials of Laparotomy

Trials testing the same drug.

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

Other Masonic Cancer Center, University of Minnesota trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01705288.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing