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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kemal GUNGORDUK | Contact | +905054921766 | drkemalgungorduk@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mugla Education and Research Hospital | Recruiting | Muğla | 35460 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15803238 | Result | 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. |
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All data can be shared if you wish
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Muğla Sıtkı Kocman University | Recruiting | Muğla | Turkey (Türkiye) |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |