Transvaginal Appendectomy

NCT ID: NCT00806429

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-12-31

Brief Summary

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

The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.

Detailed Description

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

Conditions

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

Appendicitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

appendicitis surgery laparoscopy natural orifice transluminal surgery

Study Design

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

Allocation Method

NON_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.

1

transvaginal appendectomy

Group Type EXPERIMENTAL

transvaginal appendectomy

Intervention Type PROCEDURE

patient undergoes transvaginal appendectomy

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

transvaginal appendectomy

patient undergoes transvaginal appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* ultrasound or CT-based diagnosis of acute or chronic appendicitis
* ASA classification 1 or 2

Exclusion Criteria

* BMI \>35
* on Immunosuppressive meds or immunocompromised
* on blood thinners or aspirin or abnormal coagulation tests
* h/o ectopic pregnancy, PID or endometriosis
* prior open abdominal surgery or transvaginal surgery
* with diffuse peritonitis
* evidence of abscess
* retroflexed uterus
* non english speaking
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kurt E Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Roberts KE, Solomon D, Mirensky T, Silasi DA, Duffy AJ, Rutherford T, Longo WE, Bell RL. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012 Feb;255(2):266-9. doi: 10.1097/SLA.0b013e31823b2748.

Reference Type DERIVED
PMID: 22167005 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0712003306

Identifier Type: -

Identifier Source: org_study_id