NCT07786337

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 15, 2026

Last Update Submit

August 23, 2026

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapselaparoscopyinsufflation

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Visual Analog Scale

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

    3 hours and 24 hours postop

Secondary Outcomes (2)

  • Post-operative analgesia

    0 - 3 days postoperative

  • Surgeon visibility

    immediately after surgery

Study Arms (2)

Standard insufflation

ACTIVE COMPARATOR

15 mmHg

Procedure: Standard insufflation

Low Insufflation

EXPERIMENTAL

10 mm Hg

Procedure: Low insufflation

Interventions

Standard insufflationPROCEDURE

standard insufflation pressure of 15 mm Hg

Standard insufflation
Low insufflationPROCEDURE

10 mm Hg of insufflation pressure

Low Insufflation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Shunaha Kim-Fine, MD MS

CONTACT

403-944-1438skimfine@ucalgary.ca

Louise Gofton

CONTACT

403-944-1438

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor, Head of Section of Urogynecology

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

against local IRB