Gynecologic SurgeryNCT04947982
Low Versus Standard Pressure Pneumoperitoneum
A study testing carbon dioxide in people with Gynecologic Surgery, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
The role of laparoscopy in gynecological and gyne-oncological surgery has dramatically increased over the past decades. Although laparoscopic procedure has several advantages over open surgery such as reduced blood loss, faster recovery earlier return to normal activities and work, however, postoperative pain and some… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- carbon dioxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Jul 2022
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women underwent a total laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy, salpingectomy, or pelvic and/or para-aortic lymphadenectomy
Who cannot join
- those who refused to give consent
- inability to understand the research questionnaire
- severe psychiatric or mental disorders
- American Society of Anesthesiologists (ASA) physical status classification > III
- conversion to laparotomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Education and Research Hospital
Muğla, 48000
About this study
Official title: Low Versus Standard Pressure Pneumoperitoneum in Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
The role of laparoscopy in gynecological and gyne-oncological surgery has dramatically increased over the past decades. Although laparoscopic procedure has several advantages over open surgery such as reduced blood loss, faster recovery earlier return to normal activities and work, however, postoperative pain and some hemodynamic changes sometimes discomforts the patients, lessening quality of life at postoperative period [1-3]. In clinical practice the majority of laparoscopic procedures are performed using standard pressure pneumoperitoneum (SPP, 12-15 mmHg) [1-3]. These noticeable adverse effects are associated with of creation of pneumoperitoneum with carbon dioxide (CO2) but it is requisite in all laparoscopic surgery for adequate visualization and operative manipulation.
The incidence of pain after gynecologic laparoscopies has been reported to vary from 35% to 63% [4,5]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [6]. The origin of pain after laparoscopy is multifactorial and complex. It can be differentiated into abdominal pain and shoulder pain [7]. The precise causes for such pain are still obscure. Abdominal pain may be attributed to stretching of the abdominal cavity, and peritoneal irritation due to entrapment of dissolved CO2 [1-7]. Intraperitoneal acidosis, mucosal ischemia and compression of the splanchnic nerve as a consequence of the pneumoperitoneum may also be relevant factors [8,9]. On the other hand, shoulder pain is related to phrenic nerve and diaphragm irrigation due to residual CO2 in the subdiaphragmatic space [7-9].
Read more
In addition to pain, CO2 insufflation and a concomitant steep head-down (Trendelenburg, TP) position in surgical procedure also cause an increase in intra-abdominal pressure, which unfavorably affect patients homeostasis, inducing a significant change in the respiratory and cardiovascular system, lessening perfusion in abdominal organs and blood flow in the inferior vena cava, and posing an increased risk of thrombotic disease [10,11].
Low-pressure pneumoperitoneum (LPP, 7-10 mmHg) is recommended to minimize the adverse side effects associated with SPP [12]. There are several reports on the safety of low CO2 pneumoperitoneum pressure (LPP) in gynecological laparoscopic procedures however their trials have some limitations due to the small sample size, performed in only short laparoscopic procedures, and inadequate to assess the surgical impression of visualization [13-16]. Thus, further studies are still required.
Therefore, the purpose of this randomized controlled trial (RCT) is to assess the effect of LPP versus SPP on metabolic response, postoperative pain scores, surgical field visualization.
- Conditions
- Gynecologic Surgery
- Being tested
- carbon dioxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxideOther
carbon dioxide insufflation pressure
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All laparoscopic surgical procedures were performed at 12 mmHg CO2 pressure throughout the surgery |
| Study | Experimental | All laparoscopic surgical procedures were performed at 8 mmHg CO2 pressure throughout the surgery Receives: Other: carbon dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of postoperative recovery
QoR-40 questionnaire scores. This questionnaire pertains to five dimensions of recovery: physical comfort (12 questions), emotional state (9 questions), physical independence (5 questions), psychological support (7 questions), and pain (7 questions). Each question carries 5 point Likert scale (none of the time, some of the time, usually, most of the time, and all of the time). The total score on the QoR-40 ranges from 40 (poorest possible recovery) to 200 (best possible recovery)
Measured: at 24 hours after the surgical procedure (postoperative day [POD] 1)
Secondary outcomes (1)
Abdominal and shoulder pain intensities
Before starting the study, the participants will be instructed on how to assess their pain intensity using a visual analog scale (VAS; 0 cm = no pain, 10 cm = worst pain imaginable). To improve adherence to the protocol, participants will be asked to request analgesia without hesitation if the VAS pain score is > 4.
Measured: The pain score were measured every 6 hours for 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Erzincan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947982
- Sponsor's protocol ID
- MUGLA-4
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus Standard Pressure Pneumoperitoneum in Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04947982
- Acronym / sponsor ID
- MUGLA-4
- Conditions
- Gynecologic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 1 Jul 2021 (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.
The role of laparoscopy in gynecological and gyne-oncological surgery has dramatically increased over the past decades. Although laparoscopic procedure has several advantages over open surgery such as reduced blood loss, faster recovery earlier return to normal activities and work, however, postoperative pain and some hemodynamic changes sometimes discomforts the patients, lessening quality of life at postoperative period [1-3]. In clinical practice the majority of laparoscopic procedures are performed using standard pressure pneumoperitoneum (SPP, 12-15 mmHg) [1-3]. These noticeable adverse effects are associated with of creation of pneumoperitoneum with carbon dioxide (CO2) but it is requisite in all laparoscopic surgery for adequate visualization and operative manipulation.
The incidence of pain after gynecologic laparoscopies has been reported to vary from 35% to 63% [4,5]. A randomized controlled trial has demonstrated that there may be more intense pain and greater analgesia requirements in the immediate postoperative period after laparoscopic surgery than after laparotomy [6]. The origin of pain after laparoscopy is multifactorial and complex. It can be differentiated into abdominal pain and shoulder pain [7]. The precise causes for such pain are still obscure. Abdominal pain may be attributed to stretching of the abdominal cavity, and peritoneal irritation due to entrapment of dissolved CO2 [1-7]. Intraperitoneal acidosis, mucosal ischemia and compression of the splanchnic nerve as a consequence of the pneumoperitoneum may also be relevant factors [8,9]. On the other hand, shoulder pain is related to phrenic nerve and diaphragm irrigation due to residual CO2 in the subdiaphragmatic space [7-9].
In addition to pain, CO2 insufflation and a concomitant steep head-down (Trendelenburg, TP) position in surgical procedure also cause an increase in intra-abdominal pressure, which unfavorably affect patients homeostasis, inducing a significant change in the respiratory and cardiovascular system, lessening perfusion in abdominal organs and blood flow in the inferior vena cava, and posing an increased risk of thrombotic disease [10,11].
Low-pressure pneumoperitoneum (LPP, 7-10 mmHg) is recommended to minimize the adverse side effects associated with SPP [12]. There are several reports on the safety of low CO2 pneumoperitoneum pressure (LPP) in gynecological laparoscopic procedures however their trials have some limitations due to the small sample size, performed in only short laparoscopic procedures, and inadequate to assess the surgical impression of visualization [13-16]. Thus, further studies are still required.
Therefore, the purpose of this randomized controlled trial (RCT) is to assess the effect of LPP versus SPP on metabolic response, postoperative pain scores, surgical field visualization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All laparoscopic surgical procedures were performed at 12 mmHg CO2 pressure throughout the surgery |
| Study | Experimental | Other: carbon dioxideAll laparoscopic surgical procedures were performed at 8 mmHg CO2 pressure throughout the surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women underwent a total laparoscopic hysterectomy with or without additional surgery, such as salpingo-oophorectomy, salpingectomy, or pelvic and/or para-aortic lymphadenectomy
Key exclusion criteria (5 listed)
- those who refused to give consent
- inability to understand the research questionnaire
- severe psychiatric or mental disorders
- American Society of Anesthesiologists (ASA) physical status classification > III
- conversion to laparotomy.
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 |
|---|---|---|
| carbon dioxidecarbon dioxide insufflation pressure | Other | Study |
Primary outcome
Quality of postoperative recovery
Time frame: at 24 hours after the surgical procedure (postoperative day [POD] 1)
QoR-40 questionnaire scores. This questionnaire pertains to five dimensions of recovery: physical comfort (12 questions), emotional state (9 questions), physical independence (5 questions), psychological support (7 questions), and pain (7 questions). Each question carries 5 point Likert scale (none of the time, some of the time, usually, most of the time, and all of the time). The total score on the QoR-40 ranges from 40 (poorest possible recovery) to 200 (best possible recovery)
1 secondary outcome
Abdominal and shoulder pain intensities
Time frame: The pain score were measured every 6 hours for 48 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon dioxide in people with Gynecologic Surgery, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Quality of postoperative recovery (time frame: at 24 hours after the surgical procedure (postoperative day [POD] 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2021.