Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy? Results From a Randomized Controlled Trial.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Turkey
Mugla Education and Research Hospital
RECRUITING
Muğla
Muğla Sıtkı Kocman University
RECRUITING
Muğla
Contact Information
Primary
Kemal GUNGORDUK
drkemalgungorduk@gmail.com
+905054921766
Time Frame
Start Date: 2026-03-09
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 94
Treatments
No_intervention: Control Group
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
Experimental: Study Group
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.
Sponsors
Leads: Erzincan Military Hospital

This content was sourced from clinicaltrials.gov