Health TrialsbyHealthPanel

How Low Can You Go

ConditionPelvic Organ Prolapse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Calgary

About this trial

This is a randomized controlled trial to determine if lower intraabdominal operating pressure reduces post-operative pain in patients scheduled to undergo laparoscopic uterosacral suspension surgery of the uterus or vaginal vault.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

planned laparoscopic uterosacral suspension surgery of the uterus or vaginal vault

patients with planned concomitant prolapse, hysterectomy, or anti-incontinence surgeries will be included

Disqualifiers

non-urogynecologic procedures, or conversion to open abdominal surgery will be excluded as additional or alternative sites of pain may contribute to possible confounding for the primary outcome of postoperative pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard insufflation

    Procedure/Surgery

    standard insufflation pressure of 15 mm Hg

  • Low insufflation

    Procedure/Surgery

    10 mm Hg of insufflation pressure

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Standard insufflationActive comparator 1 intervention
Group B: Low InsufflationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Visual Analog Scale

Visual analog scale minimum 0 maximum 10 0 means no pain 10 means worst possible pain

Time frame
3 hours and 24 hours postop

Secondary outcomes

1

Post-operative analgesia

total dose of morphine milligram equivalents MME used during first days after surgery.

Time frame
0 - 3 days postoperative
2

Surgeon visibility

surgeon rating of intraoperative visibility on a Likert scale of 0 - 10. 0 means no visibility. 10 = optimum visibility.

Time frame
immediately after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: