Clinical Effect Evaluation of Laparoscopic Surgery for Ov... | NCT06047730

Studies
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches

NCT06047730

Sponsor

Yingchun Ma

Status

Completed

Last Update Posted

Sep 21, 2023Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Laparoscope
Malignant Ovarian Tumor
Single-site Surgery

Interventions

operation ways

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jul 1, 2022Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Sep 14, 2023

First Submission Date that Met QC Criteria

Sep 14, 2023

First Posted Date

Sep 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2023

Last Update Posted Date

Sep 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yingchun Ma, Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches, Qianfoshan HospitalSponsor-Investigator

Lead Sponsor

Yingchun MaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multi-port laparoscopic surgery			Procedure: operation ways
transumbilical laparoendoscopic single-site surgery			Procedure: operation ways
vaginal natural orifice transluminal endoscopic surgery			Procedure: operation ways

Interventions

Name	Type	Description	Arm Group Labels	Other Names
operation ways	Procedure	nothing	multi-port laparoscopic surgery transumbilical laparoendoscopic single-site surgery vaginal natural orifice transluminal endoscopic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peroperative bleeding	peroperative bleeding	during the operation time

Secondary Outcomes

Measure	Description	Time Frame
postoperative exhaust time	postoperative exhaust time	within 3 days after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preoperative consideration was for benign ovarian tumors requiring surgical treatment.

Exclusion Criteria:

(1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

nothing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University		Jinan	Shandong		China

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided