Postoperative PainLow-PressureNCT07467577
Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy?
A study testing warm saline in people with Postoperative Pain and vNOTES, run by Erzincan Military Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The evolution of minimally invasive gynecology has transitioned from traditional laparotomy to laparoscopy, and most recently, to vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery). 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
- Postoperative Pain, vNOTES
- What is being tested?
- warm saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 30 Sep 2026
- 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
- Surgical Indication: Scheduled for elective total hysterectomy for gynecological conditions
- Deemed suitable candidates for the vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) approach by a senior gynecologic surgeon.
- American Society of Anesthesiologists (ASA) physical status classification I or III.
- Uterine volume ≤14 weeks of gestation (or a sonographically estimated weight of ≤ 500 grams) to ensure a standardized vNOTES procedural duration
- Ability to understand the study protocol and provide written informed consent, including the willingness to use the Visual Analogue Scale (VAS) for pain assessment.
- Sufficient literacy and fluency in Turkish to accurately complete postoperative pain and recovery surveys
Who cannot join
- Chronic Pain Syndromes: Diagnosis of chronic pelvic pain, fibromyalgia, or any condition requiring long-term analgesic or opioid therapy, as these may distort postoperative Visual Analogue Scale (VAS) scores.
- Extensive Adhesions: Known or suspected severe pelvic adhesions (Stage III or IV endometriosis) or a history of multiple major abdominal surgeries that might necessitate conversion to traditional laparoscopy or laparotomy.
- Uterine Size: Uterine weight exceeding 500 grams or size greater than 14 weeks of gestation, potentially requiring morcellation or prolonged surgical time.
- Anatomical Constraints: Severe vaginal stenosis or insufficient vaginal access that precludes the vNOTES approach.
- Hypersensitivity: Known allergy or hypersensitivity to local anesthetics or medications used in the standardized postoperative pain protocol.
- Psychiatric/Cognitive Disorders: Any condition that impairs the patient's ability to reliably report pain levels using the VAS or follow the study protocol.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mugla Education and Research Hospital
Muğla, 35460
Muğla Sıtkı Kocman University
Muğla
About this study
Official title: Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy? Results From a Randomized Controlled Trial.
The evolution of minimally invasive gynecology has transitioned from traditional laparotomy to laparoscopy, and most recently, to vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery). By combining the visual advantages of endoscopy with the scarless approach of vaginal surgery, vNOTES has demonstrated superior outcomes in terms of reduced postoperative pain, shorter hospital stays, and improved cosmetic results compared to traditional total laparoscopic hysterectomy (TLH).
Despite these advancements, post-laparoscopic pain syndrome (PLPS) remains a significant clinical challenge. Characterized by deep-seated abdominal pressure and referred shoulder-tip pain, PLPS is primarily attributed to the irritation of the phrenic nerve caused by residual carbon dioxide and the formation of carbonic acid on the peritoneal surface. In the Trendelenburg position required for gynecologic procedures, this gas often becomes trapped in the subdiaphragmatic space, leading to significant distress that can delay discharge even when the surgical site itself is healing well.
Read more
The physiological impact of the pneumoperitoneum is largely pressure-dependent. The landmark study by Barczyński and Herman (2004) in general surgery established that maintaining a low-pressure pneumoperitoneum (<10 mmHg) significantly reduces peritoneal stretching and the subsequent inflammatory response. Furthermore, the technique of intraperitoneal saline washout has been proposed to physically remove residual CO2 and dilute acidic metabolites, thereby mitigating phrenic nerve irritation.
While these techniques have been validated in abdominal laparoscopic procedures such as cholecystectomy, their efficacy within the unique framework of vNOTES hysterectomy remains unexplored. vNOTES naturally utilizes lower pressures than traditional laparoscopy, yet the incidence of referred pain persists. There is currently a lack of high-level evidence determining whether the addition of a standardized saline washout provides an incremental benefit over low-pressure vNOTES alone.
The aim of this prospective, randomized controlled trial is to evaluate the impact of intraperitoneal saline washout on postoperative pain scores and analgesic consumption in patients undergoing low-pressure vNOTES hysterectomy. The investigators hypothesize that the combination of low-pressure insufflation and active saline washout will result in a synergistic reduction in post-laparoscopic pain, facilitating an ultra-fast-track recovery protocol.
- Conditions
- Postoperative Pain, vNOTES
- Being tested
- warm saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm salineOther
To maintain peritoneal homeostasis and prevent thermal-induced desiccation, the irrigation fluid was standardized to normothermic saline (37°C). A volume of $25 mL/kg was administered at the conclusion of the procedure, ensuring all subdiaphragmatic CO2 pockets were effectively displaced while preserving the peritoneal fibrinolytic environment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | A standardized low-pressure pneumoperitoneum of 8 mmHg was utilized for all vNOTES hysterectomies and salpingectomies. Oophorectomy or additional surgical interventions were integrated into the procedure as required by the clinical findings |
| Study Group | Experimental | Similar to the control group, vNOTES hysterectomy in the intervention group was performed under an 8 mmHg low-pressure pneumoperitoneum. However, this group received an additional intraperitoneal washout with warm saline (25mL/kg) at the end of the surgery. Receives: Other: warm saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 h postoperative VAS score
Postoperative pain was evaluated through a visual analog scale (VAS). Patients subjectively rated their pain on a 0-10 scale, where 0 represented no pain and 10 signified the worst possible pain. Pain assessment was conducted 24 hours after surgery, with evaluations performed by clinicians experienced in using the scale.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start9 Mar 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (actual)
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
- NCT07467577
- Sponsor's protocol ID
- M21
- Acronym
- Low-Pressure
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared if you wish
Publications
Barczynski M, Herman RM. Low-pressure pneumoperitoneum combined with intraperitoneal saline washout for reduction of pain after laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2004 Sep;18(9):1368-73. doi: 10.1007/s00464-003-9299-y. Epub 2004 Jun 23.
PubMed 15803238
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy? Results From a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07467577
- Acronym / sponsor ID
- Low-Pressure / M21
- Conditions
- Postoperative Pain, vNOTES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 12 Mar 2026 (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 evolution of minimally invasive gynecology has transitioned from traditional laparotomy to laparoscopy, and most recently, to vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery). By combining the visual advantages of endoscopy with the scarless approach of vaginal surgery, vNOTES has demonstrated superior outcomes in terms of reduced postoperative pain, shorter hospital stays, and improved cosmetic results compared to traditional total laparoscopic hysterectomy (TLH).
Despite these advancements, post-laparoscopic pain syndrome (PLPS) remains a significant clinical challenge. Characterized by deep-seated abdominal pressure and referred shoulder-tip pain, PLPS is primarily attributed to the irritation of the phrenic nerve caused by residual carbon dioxide and the formation of carbonic acid on the peritoneal surface. In the Trendelenburg position required for gynecologic procedures, this gas often becomes trapped in the subdiaphragmatic space, leading to significant distress that can delay discharge even when the surgical site itself is healing well.
The physiological impact of the pneumoperitoneum is largely pressure-dependent. The landmark study by Barczyński and Herman (2004) in general surgery established that maintaining a low-pressure pneumoperitoneum (<10 mmHg) significantly reduces peritoneal stretching and the subsequent inflammatory response. Furthermore, the technique of intraperitoneal saline washout has been proposed to physically remove residual CO2 and dilute acidic metabolites, thereby mitigating phrenic nerve irritation.
While these techniques have been validated in abdominal laparoscopic procedures such as cholecystectomy, their efficacy within the unique framework of vNOTES hysterectomy remains unexplored. vNOTES naturally utilizes lower pressures than traditional laparoscopy, yet the incidence of referred pain persists. There is currently a lack of high-level evidence determining whether the addition of a standardized saline washout provides an incremental benefit over low-pressure vNOTES alone.
The aim of this prospective, randomized controlled trial is to evaluate the impact of intraperitoneal saline washout on postoperative pain scores and analgesic consumption in patients undergoing low-pressure vNOTES hysterectomy. The investigators hypothesize that the combination of low-pressure insufflation and active saline washout will result in a synergistic reduction in post-laparoscopic pain, facilitating an ultra-fast-track recovery protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –A standardized low-pressure pneumoperitoneum of 8 mmHg was utilized for all vNOTES hysterectomies and salpingectomies. Oophorectomy or additional surgical interventions were integrated into the procedure as required by the clinical findings |
| Study Group | Experimental | Other: warm salineSimilar to the control group, vNOTES hysterectomy in the intervention group was performed under an 8 mmHg low-pressure pneumoperitoneum. However, this group received an additional intraperitoneal washout with warm saline (25mL/kg) at the end of the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Surgical Indication: Scheduled for elective total hysterectomy for gynecological conditions
- Deemed suitable candidates for the vNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) approach by a senior gynecologic surgeon.
- American Society of Anesthesiologists (ASA) physical status classification I or III.
- Uterine volume ≤14 weeks of gestation (or a sonographically estimated weight of ≤ 500 grams) to ensure a standardized vNOTES procedural duration
- Ability to understand the study protocol and provide written informed consent, including the willingness to use the Visual Analogue Scale (VAS) for pain assessment.
Key exclusion criteria (6 listed)
- Chronic Pain Syndromes: Diagnosis of chronic pelvic pain, fibromyalgia, or any condition requiring long-term analgesic or opioid therapy, as these may distort postoperative Visual Analogue Scale (VAS) scores.
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 |
|---|---|---|
| warm salineTo maintain peritoneal homeostasis and prevent thermal-induced desiccation, the irrigation fluid was standardized to normothermic saline (37°C). A volume of $25 mL/kg was administered at the conclusion of the procedure, ensuring all subdiaphragmatic CO2 pockets were effectively displaced while preserving the peritoneal fibrinolytic environment. | Other | Study Group |
Primary outcome
24 h postoperative VAS score
Time frame: 24 hours
Postoperative pain was evaluated through a visual analog scale (VAS). Patients subjectively rated their pain on a 0-10 scale, where 0 represented no pain and 10 signified the worst possible pain. Pain assessment was conducted 24 hours after surgery, with evaluations performed by clinicians experienced in using the scale.
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 6 Oct 2026.
- Results publication: PubMed 15803238Barczynski M, Herman RM. Low-pressure pneumoperitoneum combined with intraperitoneal saline washout for reduction of pain after laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2004 Sep;18(9):1368-73. doi: 10.1007/s00464-003-9299-y. Epub 2004 Jun 23.
- Individual participant dataSharing planned: Yes. All data can be shared if you wish
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warm saline in people with Postoperative Pain and vNOTES, run by Erzincan Military Hospital at 2 sites 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 6 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
24 h postoperative VAS score (time frame: 24 hours). 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 NCT07467577, which also lists 1 linked publication.
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 6 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.