HysterectomyNCT04125173
Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy
A study testing Pneumoperitoneum pressure = 15mmHg, Pneumoperitoneum pressure = 12mm Hg and Pneumoperitoneum pressure = 10mmHg in people with Hysterectomy and Pneumoperitoneum, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Pneumoperitoneum
- What is being tested?
- Pneumoperitoneum pressure = 15mmHg, Pneumoperitoneum pressure = 12mm Hg and Pneumoperitoneum pressure = 10mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: The Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy: A Randomized Controlled Trial
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.
Read the detailed description
Minimally invasive hysterectomy, including conventional laparoscopic and robotic-assisted hysterectomy, is a commonly performed gynecologic surgery that universally results in postoperative pain for patients. Opioid medications are helpful to control postoperative pain and are routinely given to women who undergo minimally invasive hysterectomy. However, opioid abuse is on the rise in the United States, and there is increased awareness of misuse leading to abuse, overdose, and chronic opioid use. In addition to narcotic usage, postoperative pain also has negative effects on patient satisfaction and length of stay in the post-anesthesia care unit (PACU) leading to potential hospital admission. There is existing evidence that reducing the pressure used to create the pneumoperitoneum during laparoscopic surgery may affect pain scores that patients endorse in the PACU. Due to improved postoperative pain, patients may have decreased opioid use in the PACU and at home, shorter hospital stay, and improved overall patient satisfaction. If lower pneumoperitoneum pressures during laparoscopic surgery can be shown to reduce postoperative pain, then the ultimate question becomes whether there is ability to adapt this practice of using lower pressures to maintain pneumoperitoneum. It is unclear whether physician satisfaction will be affected.
There are several publications investigating the effect of lower pneumoperitoneum pressures on postoperative pain. A systematic review in 2016 included 238 patients (three RCTs), showed pneumoperitoneum pressures of 8mmHg had a statistically significant although minimal decrease in postoperative pain compared to 12mmHg, although lower pressures were associated with worse visualization. The authors concluded that the systematic review was inconclusive and further studies were necessary. A randomized pilot study with 60 patients comparing low pressure (7mmHg) using the AirSeal System versus standard insufflation (15mmHg), showed lower postoperative shoulder pain in the group with lower pressure using the AirSeal system. Two abstracts in the Journal of Minimally Invasive Gynecology present retrospective studies showing decreased postoperative pain with lower pneumoperitoneum pressure. The first abstract is from 2015, included a sample size of 170 patients who underwent benign robotic gynecologic surgery, 85 patients in each arm (12mmHg and 15mmHg). They showed no difference in median recovery time in the PACU and significantly lower median first pain score (5 vs 6, p=.04). The second abstract is from 2018 and included a sample size of 598 patients who underwent benign robotic gynecologic surgery, 99 patients in 15mmHg arm, 100 patients in 12mmHg arm, 99 patients in 10mmHg arm, and 300 patients in 8mmHg arm. They showed lower initial pain scores with each degree of lower pressure (5.9 vs 5.4 vs 4.4 vs 3.8, p=<.0001) and shorter hospital stays with lower pressures. They showed no difference in operative times or blood loss in the four arms. Similar studies have been done with cholecystectomy patients that have shown improved postoperative shoulder pain with lower pneumoperitoneum pressures. There is also an ongoing clinical trial that is still recruiting patients that is studying this similar comparison using 9mmHg vs 15mmHg with and without the AirSeal system.
However, the literature summarized here has never included blinding the intervention of lower pneumoperitoneum pressure to the surgeon to determine awareness of pressure and its effect on visualization and physician satisfaction.
- Conditions
- Hysterectomy, Pneumoperitoneum
- Being tested
- Pneumoperitoneum pressure = 15mmHg, Pneumoperitoneum pressure = 12mm Hg, Pneumoperitoneum pressure = 10mmHg
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum pressure = 15mmHgOther
Randomized pneumoperitoneum 1
Pneumoperitoneum pressure = 12mm HgOther
Randomized pneumoperitoneum 2
Pneumoperitoneum pressure = 10mmHgOther
Randomized pneumoperitoneum 3
| Study group | Role | What they receive |
|---|---|---|
| 1. Pneumoperitoneum pressure = 15mmHg | Active comparator | 1. Pneumoperitoneum will be set at 15mmHg Receives: Other: Pneumoperitoneum pressure = 15mmHg |
| 2. Pneumoperitoneum pressure = 12mmHg | Active comparator | 2.Pneumoperitoneum will be set at 12mmHg Receives: Other: Pneumoperitoneum pressure = 12mm Hg |
| 3. Pneumoperitoneum set at 10mmHg | Active comparator | 3. Pneumoperitoneum will be set at 10mmHg Receives: Other: Pneumoperitoneum pressure = 10mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Satisfaction Part 1
Physician satisfaction questionnaire completed immediately postoperative, 3 questions in length and measured with VAS score (0-5)
Measured: 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)
Measured: 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)
Measured: From completion of surgery to one hour postoperative
Secondary outcomes (2)
Postoperative Pain
Self reported pain intensity in PACU (VAS 0-10) first reported and maximum pain score, pain score at 6 hours postoperative, and pain score at 24 hours postoperative
Measured: From completion of surgery to 24 hours postoperative
Postoperative Shoulder Pain
Self reported shoulder pain intensity (VAS 0-10) at 6 hours postoperative and pain score at 24 hours postoperative
Measured: From completion of surgery to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start3 Mar 2020
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms including those with pneumoperitoneum pressure of 15mmgHg versus 12mmgHg vs 10 mmHg during laparoscopic or robotic hysterectomy for benign indications.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Bailey Smith, University of Arizona
- Investigators
- Michael Foley, MD, Study chair, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125173
- Sponsor's protocol ID
- 1909975965
- Status last verified
- Dec 2021
- First submitted
- 29 Jul 2019
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identifed individual participant data for all primary and secondary outcomes measures will be made available.
Publications
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.
PubMed 26955258Bogani 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.
PubMed 24374246Sroussi 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.
PubMed 284039723. 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.
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.
PubMed 25265495Nasajiyan 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.
PubMed 25225531
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04125173
- Acronym / sponsor ID
- 1909975965
- Conditions
- Hysterectomy, Pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Minimally invasive hysterectomy, including conventional laparoscopic and robotic-assisted hysterectomy, is a commonly performed gynecologic surgery that universally results in postoperative pain for patients. Opioid medications are helpful to control postoperative pain and are routinely given to women who undergo minimally invasive hysterectomy. However, opioid abuse is on the rise in the United States, and there is increased awareness of misuse leading to abuse, overdose, and chronic opioid use. In addition to narcotic usage, postoperative pain also has negative effects on patient satisfaction and length of stay in the post-anesthesia care unit (PACU) leading to potential hospital admission. There is existing evidence that reducing the pressure used to create the pneumoperitoneum during laparoscopic surgery may affect pain scores that patients endorse in the PACU. Due to improved postoperative pain, patients may have decreased opioid use in the PACU and at home, shorter hospital stay, and improved overall patient satisfaction. If lower pneumoperitoneum pressures during laparoscopic surgery can be shown to reduce postoperative pain, then the ultimate question becomes whether there is ability to adapt this practice of using lower pressures to maintain pneumoperitoneum. It is unclear whether physician satisfaction will be affected.
There are several publications investigating the effect of lower pneumoperitoneum pressures on postoperative pain. A systematic review in 2016 included 238 patients (three RCTs), showed pneumoperitoneum pressures of 8mmHg had a statistically significant although minimal decrease in postoperative pain compared to 12mmHg, although lower pressures were associated with worse visualization. The authors concluded that the systematic review was inconclusive and further studies were necessary. A randomized pilot study with 60 patients comparing low pressure (7mmHg) using the AirSeal System versus standard insufflation (15mmHg), showed lower postoperative shoulder pain in the group with lower pressure using the AirSeal system. Two abstracts in the Journal of Minimally Invasive Gynecology present retrospective studies showing decreased postoperative pain with lower pneumoperitoneum pressure. The first abstract is from 2015, included a sample size of 170 patients who underwent benign robotic gynecologic surgery, 85 patients in each arm (12mmHg and 15mmHg). They showed no difference in median recovery time in the PACU and significantly lower median first pain score (5 vs 6, p=.04). The second abstract is from 2018 and included a sample size of 598 patients who underwent benign robotic gynecologic surgery, 99 patients in 15mmHg arm, 100 patients in 12mmHg arm, 99 patients in 10mmHg arm, and 300 patients in 8mmHg arm. They showed lower initial pain scores with each degree of lower pressure (5.9 vs 5.4 vs 4.4 vs 3.8, p=<.0001) and shorter hospital stays with lower pressures. They showed no difference in operative times or blood loss in the four arms. Similar studies have been done with cholecystectomy patients that have shown improved postoperative shoulder pain with lower pneumoperitoneum pressures. There is also an ongoing clinical trial that is still recruiting patients that is studying this similar comparison using 9mmHg vs 15mmHg with and without the AirSeal system.
However, the literature summarized here has never included blinding the intervention of lower pneumoperitoneum pressure to the surgeon to determine awareness of pressure and its effect on visualization and physician satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three arms including those with pneumoperitoneum pressure of 15mmgHg versus 12mmgHg vs 10 mmHg during laparoscopic or robotic hysterectomy for benign indications.
| Arm | Type | Receives |
|---|---|---|
| 1. Pneumoperitoneum pressure = 15mmHg | Active comparator | Other: Pneumoperitoneum pressure = 15mmHg1. Pneumoperitoneum will be set at 15mmHg |
| 2. Pneumoperitoneum pressure = 12mmHg | Active comparator | Other: Pneumoperitoneum pressure = 12mm Hg2.Pneumoperitoneum will be set at 12mmHg |
| 3. Pneumoperitoneum set at 10mmHg | Active comparator | Other: Pneumoperitoneum pressure = 10mmHg3. Pneumoperitoneum will be set at 10mmHg |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumoperitoneum pressure = 15mmHgRandomized pneumoperitoneum 1 | Other | 1. Pneumoperitoneum pressure = 15mmHg |
| Pneumoperitoneum pressure = 12mm HgRandomized pneumoperitoneum 2 | Other | 2. Pneumoperitoneum pressure = 12mmHg |
| Pneumoperitoneum pressure = 10mmHgRandomized pneumoperitoneum 3 | Other | 3. Pneumoperitoneum set at 10mmHg |
Primary outcome
Physician Satisfaction Part 1
Time frame: From completion of surgery to one hour postoperative
Physician satisfaction questionnaire completed immediately postoperative, 3 questions in length and measured with VAS score (0-5)
Physician Satisfaction Part 2
Time frame: From completion of surgery to one hour postoperative
Included in the physician satisfaction questionnaire is presumed pneumoperitoneum pressure, measured as 10mmHg, 12mmHg, or 15mmHg (circle one - 10mmHg, 12mmHg, 15mmHg)
Physician Satisfaction Part 3
Time frame: From completion of surgery to one hour postoperative
Included in the physician satisfaction questionnaire are two yes/no questions on effect of pneumoperitoneum on visualization and operative time (circle one - yes, no)
2 secondary outcomes
Postoperative Pain
Time frame: From completion of surgery to 24 hours postoperative
Postoperative Shoulder Pain
Time frame: From completion of surgery to 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Background: PubMed 26955258Kyle 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.
- Background: PubMed 24374246Bogani 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.
- Background: PubMed 28403972Sroussi 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.
- Background3. 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: PubMed 25265495Topcu 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.
- Background: PubMed 25225531Nasajiyan 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.
- Individual participant dataSharing planned: Yes. De-identifed individual participant data for all primary and secondary outcomes measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Foley, MD study chair
Banner University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumoperitoneum pressure = 15mmHg, Pneumoperitoneum pressure = 12mm Hg and Pneumoperitoneum pressure = 10mmHg in people with Hysterectomy and Pneumoperitoneum, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Satisfaction Part 1 (time frame: From completion of surgery to one hour postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125173, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.