Effect of 27-Inch and 55-Inch Endoscopic Imaging Monitors on Surgical and Postoperative Outcomes in Endometrial Cancer Surgery: A Randomized Controlled Trial
| Registry | NCT07882277 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 70 (Estimated) |
| Sponsor | Metehan Uzundal (Other gov) |
| Conditions | Endometrial Cancer |
| Interventions | 27-Inch Endoscopic Imaging Monitor, 55-Inch Endoscopic Imaging Monitor (Device) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Endometrial Cancer All trials of 27-Inch Endoscopic Imaging Monitor All trials of 55-Inch Endoscopic Imaging Monitor
This study will compare the use of 27-inch and 55-inch endoscopic imaging monitors during minimally invasive surgery for women with endometrial cancer. Participants will be randomly assigned to one of the two monitor groups. All participants will undergo the same standard surgical procedure; only the monitor size used during surgery will differ. The main question is whether monitor size affects total operative time. The study will also evaluate sentinel lymph node dissection time, blood count changes, complications, infections, hospital stay, and drain-related outcomes during the first 30 days after surgery.
This is a single-center, prospective, randomized, parallel-group clinical study designed to evaluate whether endoscopic imaging monitor size affects surgical and early postoperative outcomes in minimally invasive endometrial cancer surgery. Eligible adult women with histologically diagnosed endometrial cancer who are scheduled for total laparoscopic hysterectomy with bilateral salpingectomy or salpingo-oophorectomy and bilateral sentinel lymph node dissection will be enrolled after informed consent.
Participants will be randomly assigned in a 1:1 ratio to surgery using either a 27-inch endoscopic imaging monitor or a 55-inch endoscopic imaging monitor. Both monitor systems are standard surgical imaging equipment used in routine clinical practice. The surgical procedure, operative technique, energy devices, sentinel lymph node mapping approach, and postoperative care will be standardized across both groups. No additional invasive procedure, investigational drug, biologic product, or experimental treatment will be used as part of this study.
The primary outcome measure is total operative time, defined as the time from entry of the laparoscopic optic into the abdomen after trocar placement to completion of surgery. Secondary outcomes include bilateral pelvic sentinel lymph node dissection time, number of right and left sentinel lymph nodes removed, hemoglobin and hematocrit decrease, blood transfusion requirement, intraoperative complications, postoperative complications within 30 days, postoperative infections within 30 days, Clavien-Dindo complication grade, length of hospital stay, drain requirement, and postoperative day of drain removal if a drain is placed.
Participants will be followed during hospitalization and at postoperative day 7-10 and day 30 visits. The study aims to determine whether monitor size has a measurable effect on operative performance and early postoperative outcomes in a standardized minimally invasive surgical setting.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 27-Inch Monitor Group | Experimental | Device: 27-Inch Endoscopic Imaging Monitor | Participants randomized to this arm will undergo minimally invasive endometrial cancer surgery using a 27-inch 4K-2D endoscopic imaging monitor. The surgical procedure and perioperative care will be standardized. |
| 55-Inch Monitor Group | Active comparator | Device: 55-Inch Endoscopic Imaging Monitor | Participants randomized to this arm will undergo the same minimally invasive endometrial cancer surgery using a 55-inch 4K-2D endoscopic imaging monitor. The surgical procedure and perioperative care will be standardized. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Female patients aged 18 years or older * Histologically diagnosed endometrial cancer with planned surgical treatment * Eligible for minimally invasive surgery * Planned total laparoscopic hysterectomy with bilateral salpingectomy or bilateral salpingo-oophorectomy and sentinel lymph node dissection * No severe systemic disease that would contraindicate laparoscopic surgery based on preoperative evaluation * Standard cervical four-quadrant indocyanine green injection planned for sentinel lymph node mapping * Bilateral sentinel lymph node mapping and bilateral sentinel lymph node dissection feasible during surgery * Preoperative hemoglobin level of 10 g/dL or higher * Able and willing to provide written informed consent Exclusion Criteria: * Distant metastasis detected on preoperative imaging or clinical evaluation * Not suitable for minimally invasive surgery, such as severe cardiopulmonary disease * Conversion from laparoscopy to laparotomy * Failure of bilateral sentinel lymph node mapping or inability to perform bilateral sentinel lymph node dissection * Systematic pelvic and/or para-aortic lymph node dissection performed * Body mass index of 40 kg/m² or higher * Uterine size equivalent to 12 weeks of gestation or larger * Dense bowel or omental adhesions detected intraoperatively * History of abdominal surgery through a midline incision * History of myomectomy * History of tubo-ovarian abscess * History of three or more cesarean deliveries * Need for an additional major surgical procedure outside the standardized surgical protocol * Preoperative hemoglobin level below 10 g/dL * Refusal to participate or inability to provide informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Basaksehir Cam and Sakura City Hospital | Istanbul, Istanbul | Turkey (Türkiye) |