NCT07882277

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Oct 2026Feb 2028

Study Start

First participant enrolled

October 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

October 20, 2026

Status Verified

October 1, 2026

Enrollment Period

1.3 years

First QC Date

October 6, 2026

Last Update Submit

October 12, 2026

Conditions

Keywords

Minimally Invasive SurgeryLaparoscopyLaparoscopic HysterectomySentinel Lymph Node DissectionEndoscopic Imaging MonitorMonitor Size

Outcome Measures

Primary Outcomes (1)

  • Total Operative Time

    Total operative time, defined as the time from entry of the laparoscopic optic into the abdomen after trocar placement to completion of surgery, measured in minutes.

    During surgery

Secondary Outcomes (12)

  • Bilateral Pelvic Sentinel Lymph Node Dissection Time

    During surgery

  • Number of Retrieved Sentinel Lymph Nodes

    From surgery to final pathology assessment, up to 30 days after surgery

  • Hemoglobin Decrease

    Preoperative to postoperative 24 hours

  • Hematocrit Decrease

    Preoperative to postoperative 24 hours

  • Blood Transfusion Requirement

    From start of surgery to hospital discharge, up to 30 days after surgery

  • +7 more secondary outcomes

Study Arms (2)

27-Inch Monitor Group

EXPERIMENTAL

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.

Device: 27-Inch Endoscopic Imaging Monitor

55-Inch Monitor Group

ACTIVE COMPARATOR

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.

Device: 55-Inch Endoscopic Imaging Monitor

Interventions

Use of a 55-inch 4K-2D endoscopic imaging monitor during minimally invasive endometrial cancer surgery.

55-Inch Monitor Group

Use of a 27-inch 4K-2D endoscopic imaging monitor during minimally invasive endometrial cancer surgery.

27-Inch Monitor Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (3)

  • Walczak DA, Pawelczak D, Piotrowski P, Trzeciak PW, Jedrzejczyk A, Pasieka Z. Video display during laparoscopy - where should it be placed? Wideochir Inne Tech Maloinwazyjne. 2015 Apr;10(1):87-91. doi: 10.5114/wiitm.2014.47434. Epub 2014 Dec 4.

    PMID: 25960798BACKGROUND
  • El Shallaly G, Cuschieri A. Optimum view distance for laparoscopic surgery. Surg Endosc. 2006 Dec;20(12):1879-82. doi: 10.1007/s00464-005-0162-1.

    PMID: 17031749BACKGROUND
  • Sivas MC, Aslan Cetin B, Ohanoglu Cetinel K, Geyikoglu IE. The effect of using laparoscopic imaging screens of different sizes (55-inch vs. 27-inch) on surgical parameters in hysterectomy surgery: a retrospective cohort study. BMC Surg. 2025 Oct 3;25(1):425. doi: 10.1186/s12893-025-03168-1.

    PMID: 41044554BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Metehan Uzundal, MD

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked to the assigned monitor size. Surgeons, operating room staff, and investigators will not be masked because the assigned monitor must be visible and prepared before surgery.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: surgery using a 27-inch endoscopic imaging monitor or surgery using a 55-inch endoscopic imaging monitor. The surgical procedure and perioperative care will be standardized across both groups.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Obstetrics and Gynecology Specialist, Gynecologic Oncology Fellow

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 20, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

October 20, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. Study data will be collected and analyzed in a coded and confidential manner, and participant-identifying information will not be disclosed. Results will be reported only in aggregate form.

Locations