Comparison of vNOTES and Conventional Laparoscopic Hysterectomy: A Randomized Controlled Study of Pain, Opioid Use, and Quality of Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators responsible for postoperative data collection and analysis and outcome assessors were blinded to group allocation. These investigators were not involved in the surgical or anesthetic management of the patients. Due to the nature of the surgical procedures, blinding of participants and care providers was not feasible.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
vNOTES Group
Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg.
干预措施: vNOTES Hysterectomy (Procedure)
TLH Group
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.
干预措施: Total Laparoscopic Hysterectomy (Procedure)
结局指标
主要结局
Postoperative Pain Intensity (NRS)
时间窗: At 12 and 24 hours postoperatively
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
次要结局
- Need for Rescue Analgesia Within 24 Hours(First 24 postoperative hours)
- Time to First Flatus(Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.)
- Length of Postoperative Hospital Stay(Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.)
- Change in QoR-15 Score from Baseline to 24 Hours(Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively)
- Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours(Preoperative (within 24 hours before surgery) and 24 hours postoperatively)
- Postoperative Nausea and Vomiting (PONV)(During the first 24 hours postoperatively)
- Postoperative Hemoglobin Decrease(From preoperative baseline to 24 hours postoperatively)
- Need for Rescue Analgesia Within 24 Hours(First 24 postoperative hours)
- Time to First Mobilization(From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively.)
- Time to First Flatus(Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.)
- Length of Postoperative Hospital Stay(Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.)
- Change in QoR-15 Score from Baseline to 24 Hours(Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively)
- Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours(Preoperative (within 24 hours before surgery) and 24 hours postoperatively)
- Postoperative Nausea and Vomiting (PONV)(During the first 24 hours postoperatively)
- Estimated Intraoperative Blood Loss(During surgery)
- Postoperative Hemoglobin Decrease(From preoperative baseline to 24 hours postoperatively)
- Perioperative Blood Transfusion Requirement(During surgery and up to 24 hours postoperatively)
- Postoperative Delirium and Acute Cognitive Dysfunction(Within the first 24 hours postoperatively)
研究者
Fatma Acil,MD
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital