Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy?

NCT07467577 | Recruiting

• 1 other identifier: M21
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

vNOTES; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (2)

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.

Other: warm saline

Interventions

warm saline OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (2)

Mugla Education and Research Hospital

Muğla, 35460, Turkey (Türkiye)

RECRUITING

Muğla Sıtkı Kocman University

Muğla, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 15803238 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Kemal GUNGORDUK

CONTACT

+905054921766; drkemalgungorduk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 12, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (2)