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临床试验/NCT07786337
NCT07786337尚未招募不适用

How Low Can You Go: a Randomized Controlled Trial of Normal Versus Low Intraabdominal Pressure During Laparoscopic Uterosacral Suspension Surgery

University of Calgary0 个研究点目标入组 164 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
164
主要终点
Postoperative Pain Visual Analog Scale

研究概览

简要总结

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.

详细描述

The primary objective of this research proposal is to answer the question: in patients scheduled to undergo laparoscopic uterosacral suspension surgery of the uterus or vaginal vault, does lower intraabdominal operating pressure reduce post-operative pain, measured using a standardized visual analogue scale?

Secondary outcomes include frequency of opioid and non-opioid analgesic prescriptions at time of discharge, rescue opioid analgesics in the day-surgery recovery unit, rate of unanticipated admission to hospital. Surgical safety outcomes will also be assessed including surgeon perception of operative field visibility, rate of surgeon requests to increase intraabdominal pressure, rate of conversion to open surgery, incidence of surgical complications (up to 30d post-operatively).

3.0 METHODS & STATISTICAL ANALYSIS This study will be a double-blinded randomized controlled trial patients ≥18 years of age scheduled for laparoscopic uterosacral suspension surgery of either the uterus or vaginal vault at the Foothills Medical Centre, an academic tertiary hospital. Patients scheduled to receive concomitant prolapse, hysterectomy, or anti-incontinence surgeries will be included. Patients scheduled to receive concomitant non-urogynecologic surgery or those converted to an open, abdominal surgical approach will be excluded. For participants randomized to the lower IAP group, after entry into the abdominal-pelvic cavity, pneumoperitoneum pressure will be set and maintained at 10mmHg throughout the surgery. For those randomized to the normal IAP group, after entry into the abdominal-pelvic cavity, pneumoperitoneum pressure will be set and maintained at 15mmHg.

Data collected - including but not limited to:

  1. Preoperative data:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥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

排除标准

  • 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

结局指标

主要结局

Postoperative Pain Visual Analog Scale

时间窗: 3 hours and 24 hours postop

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

次要结局

  • Post-operative analgesia(0 - 3 days postoperative)
  • Surgeon visibility(immediately after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shunaha Kim-Fine

Clinical Associate Professor, Head of Section of Urogynecology

University of Calgary

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