NCT01039129

Brief Summary

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

December 22, 2009

Last Update Submit

August 19, 2015

Conditions

GallstonesAppendicitisPelvic Pain

Keywords

GallstonesAppendicitisPelvic painPeritoneal mass

Outcome Measures

Primary Outcomes (2)

  • Technical success

    intra-operative

  • Complication

    1 month

Secondary Outcomes (2)

  • Operative time

    intra-operative

  • Sexual function

    1 year

Study Arms (3)

Endoscopic Cholecystectomy

EXPERIMENTAL

20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis).

Procedure: Endoscopic Cholecystectomy

Endoscopic Appendectomy

EXPERIMENTAL

Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.

Procedure: Endoscopic Appendectomy

Endoscopic Peritoneoscopy

EXPERIMENTAL

20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.

Procedure: Endoscopic Peritoneoscopy

Interventions

Endoscopic CholecystectomyPROCEDURE

An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.

Endoscopic Cholecystectomy
Endoscopic AppendectomyPROCEDURE

An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus

Endoscopic Appendectomy
Endoscopic PeritoneoscopyPROCEDURE

A diagnostic peritoneoscopy with or without biopsy for any indication

Endoscopic Peritoneoscopy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic or early appendicitis
  • Symptomatic gallstones
  • Suspicious abdominal mass/nodule
  • Female
  • Age 18-60 years
  • ASA Class I or II

You may not qualify if:

  • Pregnant women
  • History of previous abdominal, pelvic, or vaginal surgery
  • History of previous abdominal or pelvic radiation therapy
  • History of fibroid uterus
  • History of endometriosis
  • History of large ovarian cyst
  • History of unexplained vaginal bleeding or dyspareunia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

GallstonesAppendicitisPelvic Pain

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Julio Teixeira, MD

    St. Luke's-Roosevelt Hospital Center, Department of Surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

US(1)