Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk-Reducing Surgeries for Hereditary Ovarian Cancer

NCT03294343

Hereditary Breast and Ovarian Cancer Syndrome Colorectal Neoplasms, Hereditary Nonpolyposis Ovariectomy +1 more

UNKNOWN NA

Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

NCT00746018

Cervical Cancer Ovarian Cancer Uterine Cancer

COMPLETED NA

Molecular and Cellular Profiling of Uterine Lavage Collected During Gynecologic Surgery

NCT07044505

Gynecologic Cancer Gynecologic Disease Gynecological Surgery +1 more

RECRUITING NA

Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer

NCT00791635

Cervical Carcinoma Endometrial Carcinoma Malignant Female Reproductive System Neoplasm +2 more

ACTIVE_NOT_RECRUITING

Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy

NCT01893086

Benign Uterine Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This research study is a prospective, randomized trial. Women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon. The resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epithelial Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard surgical resection

standard surgical resection using clamps and surgical ligatures

Group Type OTHER

Standard Surgical resection

Intervention Type OTHER

standard surgical resection using clamps and surgical ligatures

LIGASURE

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Group Type ACTIVE_COMPARATOR

LIGASURE

Intervention Type DEVICE

resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Surgical resection

standard surgical resection using clamps and surgical ligatures

Intervention Type OTHER

LIGASURE

resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must be 18 years or older
* All patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants.
* Potential candidates must have signed an IRB-approved Informed Consent (University of Utah Informed consent if their surgery will be performed at the Huntsman Cancer Hospital, or Intermountain Health Care consent if the surgery is to be performed at LDSH or IMC.
* Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation.