Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2022-12-31

Brief Summary

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This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

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Detailed Description

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This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.

Study Groups

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Standard Insufflation Group

Patients will receive standard insufflation during surgery (15 mm Hg).

Group Type ACTIVE_COMPARATOR

Insufflation during surgery

Intervention Type PROCEDURE

This is the amount of insufflation using during the surgical procedure.

Low Insufflation Group

Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).

Group Type EXPERIMENTAL

Insufflation during surgery

Intervention Type PROCEDURE

This is the amount of insufflation using during the surgical procedure.

Interventions

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Insufflation during surgery

This is the amount of insufflation using during the surgical procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse.
* Age 18-90 years
* Can read and understand the consent form and consents to the procedure