Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy

NCT04125173 | Completed

• 1 other identifier: 1909975965
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

With the limited evidence that lower pneumoperitoneum pressures improve postoperative pain in laparoscopic or robotic hysterectomy for benign indications, we would like to determine if we can both further validate this idea but also show that it has minimal effect on physician satisfaction performing the surgery.

Conditions

Hysterectomy; Pneumoperitoneum

Outcome Measures

Primary Outcomes (3)

• Physician Satisfaction Part 1

  Physician satisfaction questionnaire completed immediately postoperative, 3 questions in length and measured with VAS score (0-5)

  From completion of surgery to one hour postoperative

• Physician Satisfaction Part 2

  Included in the physician satisfaction questionnaire is presumed pneumoperitoneum pressure, measured as 10mmHg, 12mmHg, or 15mmHg (circle one - 10mmHg, 12mmHg, 15mmHg)

  From completion of surgery to one hour postoperative

• Physician Satisfaction Part 3

  Included in the physician satisfaction questionnaire are two yes/no questions on effect of pneumoperitoneum on visualization and operative time (circle one - yes, no)

  From completion of surgery to one hour postoperative

Secondary Outcomes (2)

• Postoperative Pain

  From completion of surgery to 24 hours postoperative

• Postoperative Shoulder Pain

  From completion of surgery to 24 hours postoperative

Other Outcomes (6)

• Narcotic usage

  From completion of surgery to 24 hours postoperative

• Length of hospital stay

  From completion of surgery to hospital discharge time up to 7 days

• Patient Satisfaction

  From completion of surgery to 24 hours postoperative

Study Arms (3)

1. Pneumoperitoneum pressure = 15mmHg

ACTIVE COMPARATOR

1\. Pneumoperitoneum will be set at 15mmHg

Other: Pneumoperitoneum pressure = 15mmHg

2. Pneumoperitoneum pressure = 12mmHg

ACTIVE COMPARATOR

2.Pneumoperitoneum will be set at 12mmHg

Other: Pneumoperitoneum pressure = 12mm Hg

3. Pneumoperitoneum set at 10mmHg

ACTIVE COMPARATOR

3\. Pneumoperitoneum will be set at 10mmHg

Other: Pneumoperitoneum pressure = 10mmHg

Interventions

Pneumoperitoneum pressure = 15mmHg OTHER

Randomized pneumoperitoneum 1

1. Pneumoperitoneum pressure = 15mmHg

Pneumoperitoneum pressure = 12mm Hg OTHER

Randomized pneumoperitoneum 2

2. Pneumoperitoneum pressure = 12mmHg

Pneumoperitoneum pressure = 10mmHg OTHER

Randomized pneumoperitoneum 3

3. Pneumoperitoneum set at 10mmHg

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• greater than or equal to 18 years old
• English-speaking
• undergoing laparoscopic or robotic total hysterectomy for benign indications by one of the two minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix

You may not qualify if:

• patients with body max index \>35
• American Society of Anesthesiologists (ASA) score III or IV
• preoperative uterine weight estimated to be greater than 500gm (measured by sonography and using the following formula: length x width x anteroposterior diameter x 0.52)
• patients on chronic opioids for chronic pain (defined as \> 3 months regular opioid use)
• patients who refuse participation in the study
• patients who do not provide informed consent

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (6)

• Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.

  PMID: 26955258 BACKGROUND

• Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.

  PMID: 24374246 BACKGROUND

• Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(R) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.

  PMID: 28403972 BACKGROUND

• 3. Kim DK, Cheong ILY, Lee GY, Cho JH. Low pressure (8 mm Hg) pneumoperitoneum does not reduce the incidence and severity of postoperative nausea and vomiting (PONV) following gynecologic laparoscopy. Korean J Anesthesiol. 2006.

  BACKGROUND

• Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.

  PMID: 25265495 BACKGROUND

• Nasajiyan N, Javaherfourosh F, Ghomeishi A, Akhondzadeh R, Pazyar F, Hamoonpou N. Comparison of low and standard pressure gas injection at abdominal cavity on postoperative nausea and vomiting in laparoscopic cholecystectomy. Pak J Med Sci. 2014 Sep;30(5):1083-7. doi: 10.12669/pjms.305.5010.

  PMID: 25225531 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Michael Foley, MD

  Banner University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinator will have randomized the patient into one of the 3 arms. The randomized pneumoperitoneum pressure will be set for the surgical procedure and blinded to the surgeon and first assistant, either fellow or resident.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rachael Smith, DO Fellow Minimally Invasive Gynecology

Model Details: Three arms including those with pneumoperitoneum pressure of 15mmgHg versus 12mmgHg vs 10 mmHg during laparoscopic or robotic hysterectomy for benign indications.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: October 14, 2019
• Study Start: March 3, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement.

Locations

US (1)