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Hysterectomy clinical trials

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NCT ID: NCT05190939 Completed - Hysterectomy Clinical Trials

The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

An investigation comparing the reliability of dye-aided versus dye-less evaluation of urinary tract integrity during intra-operative cystoscopy among patients undergoing hysterectomy.

NCT ID: NCT05080114 Completed - Surgery Clinical Trials

Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Modified Bakay technique offers a novel colpotomy and cuff closure technique for total laparoscopic hysterectomy (TLH), and consists of placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The modified Bakay technique adds a standard apical compartment support and has the potential to facilitate the primary healing of the vaginal cuff. This study aimed to compare the surgical and clinical outcomes of the Modified Bakay technique to conventional standard technique in patients undergoing TLH.

NCT ID: NCT05063864 Completed - Hysterectomy Clinical Trials

Post-Hysterectomy Nursing Support Program

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

Objective: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy. Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially. Method: The study is a single blind, randomized controlled study conducted at the Department of Obstetrics and Gynecology in a university hospital between November 2017 and November 2018. 60 women who had hysterectomy were divided into experimental and control groups and It was evaluated on the 1-2 day, 6-7 day and 2nd month. In the study, the nursing support program was applied only to women in the experimental group.

NCT ID: NCT05037383 Completed - Clinical trials for Cesarean Section Complications

Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions

MOVIE
Start date: September 27, 2021
Phase: N/A
Study type: Interventional

During minimally invasive surgery (MIS), surgeons manipulate sharp and stiff instruments in the vicinity of fragile tissue, blood vessels, and critical nerves, where poor depth perception can have dramatic consequences. Since typically, 2-dimensional visualization is offered, to correctly infer the 3rd dimension, surgeons rely on their anatomical knowledge and experience. During unforeseen events, correct depth information can make the difference between success and failure. This explains the steep and long learning curve for surgeons. The absence of proper depth information slows down execution and leads to an unnecessary large mental load. A recent document from the European Association of Endoscopic Surgery showed that 3D shortens operative time and learning curves and reduces complications. 'What the best way is to visualize 3D content' remains an open question. Near-to-eye displays provide small screens in front of each eye, while stereoscopic displays use glasses to project the 3D content to the eyes. The Da Vinci surgical system uses two individual optical panels. These systems are bulky, or restrict head movement, thus users have remarks on the ergonomics. The glasses for stereoscopic displays obscure the view, reduce brightness, and alter the color. Correct color is crucial to recognize tissue types and details or parts in shaded areas. Stereoscopic 3D displays lead to headache and eye-fatigue, called visually induced motion sickness in 11-22% of surgeons after several surgeries. Autostereoscopic Visualization (ASV) is appealing for medical applications. Besides the improvement of depth perception, it allows 'glasses-free' operation. One of the key components of such displays is eye-tracking, that locates the eyes of the user to be able to render the 3D image to that viewpoint. ASV is a single-viewer application, which can be challenging in an operating room, with multiple people present. Therefore, a rigorous investigation is needed to maximize the performance of the algorithm and ensure the quality of service needed for medical use. It is crucial to collect data from real scenarios by recording the operation, the pose, motion of surgeons and the entire staff. These recordings will deliver solid understanding of the circumstances and rate of occurrences where eye-tracking and 3D visualization fails (or could fail). Furthermore, patterns can be recognized that could help to develop a robust eye-tracking algorithm and safety features for ASV.

NCT ID: NCT05031182 Recruiting - Laparoscopy Clinical Trials

Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

VLAP
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

NCT ID: NCT04972682 Completed - Endometrial Cancer Clinical Trials

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

SENTRY
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

NCT ID: NCT04904822 Completed - Laparoscopy Clinical Trials

Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

TLH-Bisection
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

NCT ID: NCT04886791 Recruiting - Hysterectomy Clinical Trials

Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

VANH
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy. Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness. Study design: The study concerns a single-blinded, multicentre, randomised controlled trial. Study population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication. Intervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups. Main study parameters/endpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8. The secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: vNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.

NCT ID: NCT04785638 Completed - Pain, Postoperative Clinical Trials

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

Start date: April 14, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.

NCT ID: NCT04696276 Recruiting - Ovarian Cancer Clinical Trials

Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece

ERAS
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecolodic oncology surgery (MGOS). Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.