Trial Outcomes & Findings for A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance (NCT NCT00889928)
NCT ID: NCT00889928
Last Updated: 2011-11-24
Results Overview
Completion of procedure - transvaginal removal of the gallbladder
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Day of Surgery
Results posted on
2011-11-24
Participant Flow
Participant milestones
| Measure |
Cholecystectomy
transvaginal cholecystectomy
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Baseline characteristics by cohort
| Measure |
Cholecystectomy
n=7 Participants
transvaginal cholecystectomy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.7 years
STANDARD_DEVIATION 6.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of SurgeryPopulation: All subjects on whom the procedure was attempted.
Completion of procedure - transvaginal removal of the gallbladder
Outcome measures
| Measure |
Transvaginal Cholecystectomy
n=7 Participants
|
|---|---|
|
Procedure Completion
|
7 participants
|
Adverse Events
Cholecystectomy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cholecystectomy
n=7 participants at risk
transvaginal cholecystectomy
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Herpes zoster infection neurological
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
28.6%
2/7 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural pain
|
85.7%
6/7 • Number of events 8
|
|
Injury, poisoning and procedural complications
Urethral injury
|
14.3%
1/7 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER