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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04947982
Study groupRoleWhat they receive
ControlNo interventionAll laparoscopic surgical procedures were performed at 12 mmHg CO2 pressure throughout the surgery
StudyExperimentalAll 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.

  1. 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)
  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.

  1. First posted1 Jul 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jul 2022 (estimated)

Resources

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)
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

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.

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