vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery" (VNOTES-TLH)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status: Enrolling

Conditions: Hysterectomy

Treatments: Procedure: Total Laparoscopic Hysterectomy; Procedure: vNOTES Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07306507

11/7/2025-705

Details and patient eligibility

About

This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes.

Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients.

Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.

Full description

This study is a single-center, prospective, randomized controlled clinical trial designed to compare two minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to determine whether vNOTES offers advantages in postoperative pain control, opioid requirements, and early recovery outcomes by eliminating abdominal wall incisions and reducing pneumoperitoneum-related physiological effects.

Eligible ASA I-II female patients aged 18-75 scheduled for elective hysterectomy are randomly assigned in a 1:1 ratio to the vNOTES or TLH group using a computer-generated sequence with sealed opaque envelopes for allocation concealment. All procedures are performed by the same experienced surgical and anesthesia team using a standardized general anesthesia protocol. Postoperative analgesia and recovery care are identical for both groups to ensure uniformity of perioperative management.

In the vNOTES group, hysterectomy is performed via transvaginal access using a self-retaining vaginal port, with pneumoperitoneum pressure kept at or below 15 mmHg. In the TLH group, a standard laparoscopic approach using a 10 mm umbilical port and two 5 mm accessory trocars is applied, with pneumoperitoneum maintained between 12-15 mmHg. Trendelenburg positioning is used in both techniques but is expected to be less steep and shorter in duration in the vNOTES group.

Outcome assessment is conducted by nurses and clinicians blinded to group allocation. Primary endpoints include postoperative pain scores at 12 and 24 hours (measured using a 0-10 Visual Analog Scale) and total opioid consumption within the first 24 hours. Secondary endpoints include Quality of Recovery-15 (QoR-15) scores, Fatigue Assessment Scale (FAS) scores, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications such as nausea/vomiting, shoulder pain, and respiratory discomfort. The study is powered based on a one-tailed hypothesis expecting lower postoperative discomfort in the vNOTES group.

The findings of this trial may help clarify whether vNOTES provides superior postoperative comfort and enhanced recovery compared to standard laparoscopic hysterectomy, contributing evidence to guide technique selection in minimally invasive gynecologic surgery.

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged 18 to 75 years
• ASA physical status I-II
• Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)
• Able to understand study procedures and provide written informed consent
• Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)

Exclusion criteria

• ASA III-IV status
• Severe cardiopulmonary disease or contraindication to general anesthesia
• Coagulopathy or bleeding disorders
• Active pelvic infection
• History of extensive pelvic or abdominal surgery complicating minimally invasive access
• Cognitive impairment or inability to complete questionnaires
• Conversion to laparotomy
• Known allergy or intolerance to study medications (paracetamol, tramadol)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

vNOTES Group

Experimental group

Description:

Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg.

Treatment:

Procedure: vNOTES Hysterectomy

TLH Group

Active Comparator group

Description:

Patients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg.

Treatment:

Procedure: Total Laparoscopic Hysterectomy