NCT00835250

Brief Summary

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

February 2, 2009

Last Update Submit

March 11, 2013

Conditions

Cholelithiasis

Keywords

Transvaginal cholecystectomyNOTESMinilaparoscopyEndoscopic surgeryCholecystectomySurgical translumenal endoscopic surgeryTransvaginal translumenal endoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Parietal complications after surgery (infection and hernia)

    One year

Secondary Outcomes (1)

  • Surgical pain. General complications. Patient's preferences.

    One year

Study Arms (3)

Laparoscopy

ACTIVE COMPARATOR

Laparoscopic cholecystectomy

Procedure: Cholecystectomy

Transumbilical

EXPERIMENTAL

Transumbilical endoscopic cholecystectomy

Procedure: Cholecystectomy

Transvaginal

EXPERIMENTAL

Transvaginal endoscopic cholecystectomy

Procedure: Transvaginal hybrid NOTES cholecystectomyProcedure: Cholecystectomy

Interventions

Transvaginal hybrid NOTES cholecystectomyPROCEDURE

Cholecystectomy performed by using a combination of working tools inserted through the entry port for the minilaparoscopy and the videogastroscope, inserted into peritoneal cavity by transvaginal approach. The gallbladder is removed transvaginally through the videogastroscope.

Also known as: NOTES cholecystectomy, Transvaginal cholecystectomy
Transvaginal
CholecystectomyPROCEDURE

Extirpation of the gallbladder by a surgical procedure

LaparoscopyTransumbilicalTransvaginal

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18 and under 65
  • symptomatic cholelithiasis with an indication for performing laparoscopic surgery
  • absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
  • perforated hymen
  • agreement on the patient's part not to use the vagina for two weeks after the surgery
  • signed specific informed consent upon providing specific information about the new surgical approach.

You may not qualify if:

  • age under 18 or over 65
  • unperforated hymen
  • presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07140, Spain

Location

Related Publications (2)

  • Dolz C, Noguera JF, Martin A, Vilella A, Cuadrado A. [Transvaginal cholecystectomy (NOTES) combined with minilaparoscopy]. Rev Esp Enferm Dig. 2007 Dec;99(12):698-702. doi: 10.4321/s1130-01082007001200004. Spanish.

    PMID: 18290693RESULT

  • Noguera JF, Cuadrado A, Dolz C, Olea JM, Garcia JC. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012 Dec;26(12):3435-41. doi: 10.1007/s00464-012-2359-4. Epub 2012 May 31.

    PMID: 22648123DERIVED

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Angel Cuadrado, MD PhD

    Hospital Son Llàtzer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Department of Surgery

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

April 1, 2012

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

ES(1)